Maturitas 77 (2014) 73–77
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Telephone-guided Self-Help Cognitive Behavioural Therapy for menopausal symptoms Evgenia Stefanopoulou, Myra S. Hunter ∗ Institute of Psychiatry, King’s College London, London, UK
a r t i c l e
i n f o
Article history: Received 24 July 2013 Received in revised form 19 September 2013 Accepted 23 September 2013
Keywords: Telephone-guided Self-Help CBT Menopause Hot flushes
a b s t r a c t Objectives: Group and Self-Help forms of Cognitive Behavioural Therapy (CBT) are effective treatment options for women with problematic menopausal hot flushes and night sweats (HF/NS). However, some women are unable to attend face-to-face sessions. This study investigates whether Self-Help CBT for HF/NS is as effective when rolled out to women living at a distance with minimal telephone guidance. Study design: Forty-seven women completed a Self-Help CBT intervention (booklet and relaxation/paced breathing CD) during a 4-week period. They also received one ‘guiding’ telephone call from a clinical psychologist two weeks into treatment to provide support and discuss individual treatment goals. Questionnaires were collected at baseline, 6 weeks (post-treatment) and 3 months (follow-up) after the end of the intervention. Main outcome measures: HF/NS problem rating. Secondary outcome measures: HF/NS frequency, HF/NS beliefs and behaviours, sleep, anxiety and depressed mood. Results: There was a significant reduction in HF/NS problem-rating following the intervention which was maintained at follow-up. Moreover, women reported less frequent HF/NS along with further improvements in sleep quality, mood and HF/NS beliefs and behaviours. Conclusions: Telephone-guided Self-Help interventions might provide an effective way of widening access to CBT treatment for HF/NS. © 2013 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Cognitive Behavioural Therapy (CBT) has been found to reduce the impact of hot flushes and night sweats (HF/NS) in recent randomised controlled trials (MENOS 1 and MENOS 2) with well women and breast cancer patients [1,2]. HF/NS are the cardinal symptoms of the menopause transition and can negatively impact on sleep, mood and quality of life [3,4]. Guided Self-Help CBT was found to be as effective as Group CBT in reducing HF/NS problemrating or interference [1] and may be offered in order to widen access to treatment for women experiencing troublesome symptoms. Indeed, use of Self-Help formats has been found to be a cost-effective method of delivering treatments for anxiety and depression [5]. The UK National Health Service (NHS) also recognises that Self-Help CBT and other self-management interventions play an important role in addressing health inequalities in chronic symptom management [5,6]. Typically, guided Self-Help consists of a psychological intervention involving the patient taking home a standardised psychological manual in a written format (e.g. in a booklet, downloadable pdf
∗ Corresponding author. Tel.: +44 207 188 0180. E-mail address: [email protected] (M.S. Hunter). 0378-5122/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.maturitas.2013.09.013
etc.) and working through it in an independent manner [7,8]. Using step-by-step instructions, patients can learn how to apply a generally accepted psychological treatment to address their own needs; moreover, minimal time is required by a therapist, whose role is primarily supportive in helping the patient to work through the treatment her/himself. Therapist input tends to be maintained at a fairly minimal level by brief face-to-face contact, telephone, email or other communication methods [5]. However, guided Self-Help interventions often come in many forms and with different levels and types of therapist input, which may have significant implications for the costs of the treatments or their effectiveness [9]. For instance, although strong associations between higher levels of therapist input and better health-related outcomes have been reported [9], a recent meta-analysis suggested comparable outcomes between guided Self-Help and face-to-face interventions for anxiety and mood disorders; consequently, the authors argued that it may not be so much the intensity of therapist input (e.g. type, number or length of sessions) that makes a difference, but rather having contact between the two people in itself [5]. A CBT treatment for menopause-related HF/NS was developed based on a theoretical model of HF/NS, which outlines specific components (e.g. biological, psychological and social factors) and how these might influence women’s experiences of HF/NS [10,11]. In
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E. Stefanopoulou, M.S. Hunter / Maturitas 77 (2014) 73–77
the MENOS 2 trial [1], women received CBT in a Self-Help format (i.e. booklet and relaxation/paced breathing CD) and had two contacts with a therapist: one face-to-face session during which the CBT approach was explained and a guiding phone call 2 weeks into treatment. Women reported significantly less problematic HF/NS compared to no-treatment controls at the end of intervention, which remained significant at 6 months follow-up [1]. During qualitative interviews carried out after the end of follow-up assessments, women reported finding the Self-Help approach beneficial [12]. Nevertheless, some women were unable to participate or attend face-to-face sessions due to travelling distance. This study investigates whether a guided Self-Help CBT intervention for HF/NS can be as effective as MENOS 2 Self Help CBT [1] when rolled out to women living at a distance with minimal telephone guidance. Findings are therefore discussed in relation to MENOS 2 data. HF/NS problem rating at post-treatment was selected as the most appropriate primary outcome measure because it is associated with reduced quality of life [4,13,14]. Secondary outcome measures included HF/NS frequency, beliefs and behavioural reactions towards HF/NS, sleep, anxiety and depressed mood. 2. Methods 2.1. Participants Women with variable menstrual cycles (menopause transition) or who were more than one year from their last menstrual period (post-menopause) with problematic HF/NS were recruited from websites and newspaper advertisements. Inclusion criteria: English speaking women, 18 years old or older, having problematic HF/NS (score > 2 on the Hot Flush Rating Scale (HFRS)) [11] for at least 1 month and minimum frequency of 10 flushes per week) and unable to attend for face-to-face interviews (e.g. living outside London) [1]. Exclusion criteria: non English speaking women and/or with history of medical or psychiatric conditions that would affect their ability to participate. 2.2. Procedure Potential participants were initially contacted by telephone for a screening assessment, which included an eligibility check and an explanation of the research procedure. If eligible and interested, they were sent information together with a consent form and assessment questionnaires, which they completed and returned to the research team using a freepost envelope. On receipt of the questionnaires and signed consent forms, the intervention was sent out. Another set of questionnaires was sent out at 6 weeks (posttreatment) and again at 3 months (follow-up) after the end of the intervention. Ethical approval was obtained from Kings College London Research Ethics Committee (Psychiatry, Nursing and Midwifery Research Ethics Subcommittee, reference: PNM/08/09-42). All participants gave written informed consent before taking part. 2.3. Intervention The intervention included psychoeducation, paced breathing and relaxation, and CBT to help women to manage HF/NS [1,15]. The intervention has been shown to be acceptable to women and has shown effectiveness in randomised clinical trials of Self-Help and group CBT [1,2]. It is based on a cognitive behavioural model of HF/NS that describes how a range of psychological factors might influence the physiological mechanisms as well as women’s perception and appraisal of HF/NS [10]. The model includes four stages
of HF/NS experience: physiological processes, symptom perception, cognitive appraisal and behavioural reactions to symptoms. Research examining the cognitive appraisals of HF/NS suggests that negative thoughts and beliefs about HF/NS are associated with problematic HF/NS, whereas calm thoughts, accepting the symptoms and not over-reacting, are associated with less problematic symptoms [10,16]. Negative attitudes to menopause have been found to be correlated with negative beliefs about HFNS [16], and depressed mood and anxiety have been found to be associated with more problematic HFNS. Self-Help CBT included a booklet completed over a four-week period. The content of Self-Help CBT was identical to a Group CBT intervention delivered in previous trials [1,2] with participants receiving a relaxation/paced breathing CD for daily practice and completing weekly homework tasks (e.g. daily diaries of their HF/NS so that they could monitor their own progress). The booklet also included interactive exercises with space for participants to write relevant information. The booklet content has been described previously: week 1 introduced participants to the CBT model of HF/NS and stress; week 2 introduced cognitive and behavioural strategies for dealing with HF; week 3 focused on managing NS and sleep and during week 4 participants reviewed individual goals and developed a maintenance plan (for more detailed information see [1,15]). Telephone guiding consisted of a telephone call from a clinical psychologist 2 weeks into treatment to provide support and discuss individual treatment goals. The psychologist discussed participants’ progress in reading through the materials and practising the exercises (e.g. cognitive and behavioural strategies, relaxation and breathing exercises). Possible barriers were identified (e.g. time constraints) and practical strategies to overcome these were considered. Telephone guiding lasted on average 25 min (range 15–35 min). Women were also provided with the contact details of the clinical psychologist in case they wished to gain clarification regarding anything they did not understand. 2.4. Measures Sociodemographic information, menopausal status, health and lifestyle questions were included with the following standardised questionnaires. The Hot Flush Rating Scale (HFRS) [11] is a self-report measure of HF/NS frequency and problem-rating over the past week. Problemrating is calculated as the mean of the scores on three Likert scales (scores range from 1–10) assessing the extent to which HF/NS are problematic, distressing and causing interference in daily life. Higher scores indicate more problematic HF/NS whereas a 2-point change on the scale is considered clinically significant. The scale has shown good test–retest reliability and concurrent validity. The Hot Flush Beliefs Scale (HFBS) [16] is a 27-item questionnaire, which assesses women’s beliefs about their HF/NS. It consists of three sub-scales (scores range from 0–5) reflecting negative beliefs about (i) hot flushes in a social context, (ii) coping/control over HF/NS and (iii) coping with night sweats and sleep. Higher scores indicate more negative beliefs. Internal consistency of the subscale items ranged between 0.78 and 0.93 and test–retest reliability ranged between 0.74 and 0.78. The Hot Flush Behaviour Scale (HFBehS) [17] is an 11-item questionnaire that measures behavioural strategies used to deal with HF/NS. It consists of three subscales (scores range from 0–5) assessing (i) behavioural avoidance, (ii) practical cooling behaviours and (iii) positive behavioural strategies. The scale has shown adequate internal consistency and concurrent criterion validity. The Women’s Health Questionnaire (WHQ) [18] is a reliable tool in assessing women’s perceptions of emotional and physical health
E. Stefanopoulou, M.S. Hunter / Maturitas 77 (2014) 73–77 Table 1 Sample characteristics: mean (standard deviation) or percentage %.
7
Telephone-guided CBT (N = 47)
Control (MENOS 2) Self-Help (MENOS 2)
6
Telephone-Guided Self-Help
54.82 ± 6.81 (44–77) 93.6 2.1 4.3 30.4 69.6
5 PROBLEM RATING SCORES
Age (years) Mean ± SD (range) Ethnicity % White Asian Black Menopausal status % Post-menopausal Perimenopause BMI Average weight Overweight or obese Surgical menopause % Oophorectomy Hysterectomy Marital status % Single Married/with a partner Divorced/Separated/Widowed Educational level % University/higher education School education (up to 18 year) No formal qualification Employment status % Full time Part time Not employed/Retired Smoking status % Current smoker Ex-smoker Never smoked Exercise % Rarely/never ≤1/week 2–6/week Daily Alcohol % 0–6 units 7–13 units 14+units
75
4
3
48.9 51.1
2
6.4 8.5
1
8.5 76.6 14.9
0
53.2 42.5 4.3 51.1 25.5 23.4 8.5 27.7 63.8 8.5 27.7 44.7 19.1 68.1 21.3 10.6
and has shown reasonable concurrent validity. Sleep, depressed mood and anxiety were the three subscales used in this study. 2.5. Data analysis Based on our previous findings a sample size of 40 has 90% power to detect a clinically relevant difference in mean HF/NS problem rating of 2 points, allowing for baseline value (estimated to have a mean of 5 and SD of 2.4) and a correlation between baseline and posttreatment values of 0.4 (giving a correction factor of 0.84) with two-sided significance level of 0.05 [1,2]. All analyses were completed in SPSS 18.0. Possible differences in outcome measures between (a) baseline and post-treatment and (b) baseline and follow-up were examined using paired samples t-tests. Between groups analyses were conducted on the primary outcome (i.e. problem rating scores at post-treatment) comparing the current sample with the no treatment control arm of the MENOS 2 trial (n = 45) using difference scores and baseline scores as a covariate. 3. Results 3.1. Sample characteristics Sample characteristics are presented in Table 1. Fifty-six women expressed interest in the study and forty-seven women met the inclusion criteria. The sample (n = 47) had a mean age of 54.82 (SD 6.81), ranging from 44 to 77 years old; 30% were perimenopausal
Baseline
Post-treatment TIME
Follow-up
(3 months for Telephone Self-Help CBT; 6 months for MENOS2 trial)
Fig. 1. HF/NS Problem rating mean scores at baseline, post-treatment and followup for Telephone-Guided (T-G) Self-Help CBT with MENOS2 Self-Help and control groups for comparison.
and 70% postmenopausal. The majority were white, married or cohabiting; educational level was fairly evenly divided between those educated up to and more than 18 years and three quarters were in employment. They drank on average between 0 and 6 units of alcohol per week (68.1%); 4 women were current cigarette smokers and 13 past smokers. They tended to be slightly overweight (mean body mass index (BMI) = 25.56, SD = 3.76) and 63% exercised regularly (a least twice a week). 34% of women had sought help from their GP/hospital doctor for their menopausal symptoms; 12% had used hormone replacement therapy (HRT) in the past and 6% were current users but were still symptomatic with problematic HF/NS. 3.2. Baseline measures Women estimated they were having on average 55 (SD 38.34) HF/NS per week. 44.21 (SD 34.97) were hot flushes and 15.44 (11.22) were night sweats. Average duration of HF/NS was 6.14 years (ranging from 4 months to 33 years; SD 7.47 years) and the mean HF/NS problem-rating scores were 6.23 (SD 2.16; range 1–10), reflecting frequent, chronic and moderately problematic HF/NS. Baseline WHQ, HFBS and HFBehS scores are presented in Table 2; scores were very similar to baseline MENOS 2 baseline data [1]. 3.3. Primary and secondary outcomes 3.3.1. Hot flushes and night sweats Compared to baseline, women reported a significant reduction in both the problem-rating scores (t (38) = 5.88, p < 0.0001) and frequency of HF/NS per week (t (40) = 3.42, p = 0.001) at posttreatment (see Table 2). At follow-up, women reported mean HF/NS problem-rating of 2.98 (SD 1.36) and 28.54 (SD 27.55) HF/NS per week. Differences from baseline for problem rating (t (31) = 7.40, p < 0.0001) and frequency (t (32) = 3.31, p = 0.002) remained significant at 3 months follow-up. Furthermore, the percentage of women reporting a clinically significant improvement greater than a 2-point reduction from baseline on the HF/NS problem rating scale was 63% (95% CI, 48–78) at post-treatment and 70% (95% CI, 54–86) at follow-up, respectively. The figures depict the mean problem rating scores (Fig. 1),
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Table 2 Questionnaire scores at baseline, post-treatment and follow-up for telephone-guided CBT group. Telephone Guided CBT Mean (SD)
Hot Flush Rating Scale Frequency Problem rating Women’s Health Questionnaire Depressed mood Anxiety Sleep Hot Flush Beliefs Scale Beliefs about social context Hot flush coping/control Night sweats/sleep Hot Flush Behaviours Scale Cooling behaviours Positive coping Avoidance
Baseline
Post-treatment
Follow-up
55.52 (38.34) 6.23 (2.16)
37.85 (30.33)** 3.74 (1.87)**
28.54 (27.55)** 2.98 (1.36)**
0.32 (0.26) 0.46 (0.29) 0.65 (0.31)
0.21 (0.24)* 0.33 (0.25)** 0.52 (0.34)*
0.16 (0.19)** 0.24 (0.27)** 0.51 (0.36)**
2.60 (1.19) 2.84 (0.98) 2.59 (0.96)
2.04 (1.04)** 2.17 (0.75)** 2.04 (1.06)**
1.44 (0.85)** 1.80 (0.72)** 1.83 (0.99)**
3.53 (1.37) 2.61 (1.02) 1.41 (1.06)
3.51 (1.25) 3.47 (0.93)** 1.01 (0.92)*
3.37 (1.25) 3.84 (0.83)** 0.81 (0.79)**
*p < 0.05, **p < 0.01 (paired t-tests from baseline).
and the percentages of participants with a clinically significant improvement from baseline of 2 points on the same scale (Fig. 2); data from Self-Help CBT and no-treatment control group (MENOS 2 trial) are also included for comparison. Further analysis was conducted on the primary outcome (i.e. difference in problem rating scores between baseline and posttreatment) comparing women in this study with the no treatment control arm of the MENOS2 trial [1]. We found significant group differences on problem rating scores (F [1,79] = 13.38, p < 0.0001), with the telephone-guided Self-Help reporting fewer problematic flushes at post-treatment (mean [SD] difference scores 2.37 [2.52] than the no treatment control group 0.77 [1.56]; adjusted mean difference 1.40; 95% CI, 0.64–2.16). 3.3.2. Mood, HF/NS beliefs and behaviours Compared to baseline, participants reported a significant increase in positive coping (t (37) = −4.89, p < 0.0001) and reductions in avoidance (t (37) = 2.30, p = 0.02) behaviour scores (HFBehS) at post-treatment; scores in safety behaviours did not change significantly from baseline. Similarly, reductions were reported in negative beliefs (HFBS) about experiencing flushes in a social context (t (37) = 3.62, p = 0.001), coping/control (t (38) = 4.04, p < 0.0001) and night sweats/sleep (t (40) = 3.34, p = 0.002) subscales. In terms of WHQ scores, there were significant reductions in depressed mood (t (40) = 2.63, p = 0.01), anxiety (t
Fig. 2. Percentages of participants with a clinically significant improvement from baseline of 2 points on the HF/NS Problem Rating Scale at post-treatment and followup for telephone-guided Self-Help compared with MENOS 2 groups (self-help CBT, and no treatment control).
(40) = 3.10, p = 0.004) and sleep (t (40) = 2.26, p = 0.02) subscales. All differences from baseline remained statistically significant at follow-up (p < 0.05 for all comparisons). 4. Discussion This study aimed to investigate whether a Self-Help CBT intervention for HF/NS can be as effective when rolled out to women living at a distance with minimal telephone guidance, compared to outcomes obtained in the setting of a randomised controlled trial which included face to face contact [1]. In doing so, we wished to make the intervention more widely accessible to women who were not able to attend face-to-face sessions. Telephone-guided Self-Help CBT produced clinically significant changes in HF/NS problem rating (approximately 40% reduction in problem rating scores) at post-treatment which also remained significant at 3 month follow-up. This level of improvement is comparable to the MENOS 2 results (approximately 49% reduction in scores for Self-Help group at post-treatment) [1]. Moreover, 63% of telephone-guided Self-Help and 73% of MENOS 2 Self-Help CBT participants reported a clinically significant improvement of 2 points or more on the HF/NS problem rating scale at post-treatment whilst changes were maintained at follow-up (70% and 72%, respectively). Statistical analysis comparing this telephone guided intervention with the MENOS 2 no treatment control group showed significant group differences in the primary outcome (problemrating at post treatment), which is consistent with MENOS 2 outcomes. Similarly, women reported less frequent symptoms at post-treatment and follow-up along with further improvements in sleep quality, mood as well as positive changes in HF/NS beliefs and behaviours. Taken together, findings from this study appear to support the view that the mode of therapist input might not have a significant effect on treatment outcome [5,19]. However, there is some evidence that guided Self-Help is more effective than unguided Self-Help for the treatment of anxiety and depression [20,21]. In the current study women received the same content of treatment as in previous trials [1,2] but this was delivered face by a single telephone guiding session only. In the MENOS 1 and 2 trials, participants had an initial face-to-face interview with a clinical psychologist explaining the treatment plus a telephone guiding session [1,2]. Moreover, in the current study, although women were provided with the contact details of the clinical psychologist, none of the participants contacted the therapist to discuss the materials (booklet, CD) further. It is possible that the brief contact with the therapist, rather than the intensity of such input, might
E. Stefanopoulou, M.S. Hunter / Maturitas 77 (2014) 73–77
influence outcome [5], but also that the Self Help CBT booklet alone is sufficient for women to manage their menopausal symptoms. Guided versus unguided CBT for HF/NS could be tested in future research. Future research might usefully explore preferences for modes of delivery of CBT, such as guided Self-Help or computerised CBT or Group CBT [22]. In the MENOS 2 trial, women who received Group CBT did obtain more general improvements in mood and quality of life than those who received Self-Help CBT, even though findings were remarkably similar for the main outcome (HF/NS problem rating) [1]. Similarly, further research is warranted to evaluate the acceptability and efficacy of Self-Help CBT with women from more culturally diverse backgrounds, since our sample comprised mostly of white British, reasonably well-educated participants. In terms of other limitations, we only included a three month post treatment follow up period in this study, rather than the six month post randomisation follow up in MENOS 2 – a difference of 2 months as treatment was over one month. No control group was included in this study and therefore we cannot determine whether improvements occurred because of the CBT intervention only. However, we were able to compare this sample with the control arm of the MENOS 2 trial. We tested a naturalistic roll out of the intervention and found that the results are broadly comparable to those obtained in the context of a randomised controlled trial. In terms of clinical implications, it is possible that this Self-Help CBT intervention might also help to alleviate cancer treatmentrelated HF/NS which are prevalent and troublesome for breast cancer survivors [2], as well as for men experiencing problematic HF/NS following hormone treatments for prostate cancer [23]. 5. Conclusions Findings from the current study suggest that telephone-guided Self-Help CBT might be an effective way of delivering an intervention for HF/NS for women who have difficulty in accessing face-to-face CBT. However, Group CBT might be considered for those who prefer a group format or who have low mood and/or quality of life. Ideally a choice of formats could be offered. Contributors MSH was the principal investigator of the study; ES carried out the guided self-help intervention and both authors prepared and approved the final manuscript. Competing interest None. Funding None.
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Acknowledgements We would like to thank Eleanor Mann and Rowena Barber for their help with data collection in the early stages of this study. References [1] Ayers B, Smith M, Hellier J, Mann E, Hunter MS. Effectiveness of group and Self-Help Cognitive Behavior Therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. Menopause 2012;19:749–59. [2] Mann E, Smith MJ, Hellier J, Balabanovic JA, Hamed H, Grunfeld EA, Hunter MS. Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncol 2012;13:309–18. [3] Archer DF, Sturdee DW, Baber R, et al. Menopausal hot flushes and night sweats: where are we now. Climacteric 2011;14:515–28. [4] Ayers B, Hunter MS. Health-related quality of life of women with menopausal hot flushes and night sweats. Climacteric 2013;16:235–9. [5] Cuijpers P, Donker T, Van Straten A, Li J, Andersson G. Is guided Self-Help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010;40, 1943-57. [6] Department of Health. Research evidence on the effectiveness of self care support. London: Stationery Office; 2007. [7] Marrs RW. A meta-analysis of bibliotherapy studies. Am J Community Psychol 1995;23:843–70. [8] Cuijpers P, Schuurmans J. Self-Help interventions for anxiety disorders: an overview. Curr Psychiatry Rep 2007;9:284–90. [9] Palmqvist B, Carlbring P, Andersson G. Internet-delivered treatments with or without therapist input: does the therapist factor have implications for efficacy and cost. Expert Rev Pharmacoecon Outcomes Res 2007;7:291–7. [10] Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res 2010;69:491–501. [11] Hunter MS, Liao KLM. A psychological analysis of menopausal hot flushes. Br J Clin Psychol 1995;34:589–99. [12] Balabanovic J, Ayers B, Hunter MS. Cognitive behaviour therapy for menopausal hot flushes and night sweats: a qualitative analysis of women’s experiences of group and Self-Help CBT. Behav Cogn Psychoth 2012;1:1–17. [13] Hunter MS, Rendall M. Bio-psycho-socio-cultural perspectives on menopause. Best Pract Res Clin Obstet Gynaecol 2007;21:261–74. [14] Rand KL, Otte JL, Flockhart D, et al. Modeling hot flushes and quality of life in breast cancer survivors. Climacteric 2011;14:171–80. [15] Hunter MS, Smith M. Managing Hot Flushes and Night Sweats: A Cognitive Behavioural Guide to Menopause. Sussex, UK: Routledge; 2013. [16] Rendall MJ, Simonds LM, Hunter MS. The Hot Flush Beliefs Scale: a tool for assessing thoughts and beliefs associated with the experience of menopausal hot flushes and night sweats. Maturitas 2008;60:158–69. [17] Hunter MS, Ayers B, Smith M. The Hot Flush Behavior Scale: a measure of behavioral reactions to menopausal hot flushes and night sweats. Menopause 2011;18:1178–83. [18] Hunter MS. The Women’s Health Questionnaire: a measure of mid-aged women’s perceptions of their emotional and physical health. Psychol Health 1992;7:45–54. [19] Andersson G, Carlbring P, Grimlund A. Predicting treatment outcome in Internet versus face to face treatment of panic disorder. Comput Hum Behav 2008;24:1790–801. [20] Knaevelsrud C, Maercker A. Internet-based treatment for PTSD reduces distress and facilitates the development of a strong therapeutic alliance: a randomized controlled clinical trial. BMC psychiatry 2007;7:13–23. [21] Hirai M, Clum GA. A meta-analytic study of Self-Help interventions for anxiety problems. Behav Ther 2006;37:99–111. [22] Spek V, Cuijpers PIM, Nyklícek I, Riper H, Keyzer J, Pop V. Internet-based 417 cognitive behaviour therapy for symptoms of depression and anxiety: a metaanalysis. Psychol Med 2007;37:319–28. [23] Yousaf O, Stefanopoulou E, Grunfeld EA, Hunter MS. A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN): trial protocol. BMC Cancer 2012;12:230–7.
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Telephone-guided Self-Help Cognitive Behavioural Therapy for menopausal symptoms Evgenia Stefanopoulou, Myra S. Hunter ∗ Institute of Psychiatry, King’s College London, London, UK
a r t i c l e
i n f o
Article history: Received 24 July 2013 Received in revised form 19 September 2013 Accepted 23 September 2013
Keywords: Telephone-guided Self-Help CBT Menopause Hot flushes
a b s t r a c t Objectives: Group and Self-Help forms of Cognitive Behavioural Therapy (CBT) are effective treatment options for women with problematic menopausal hot flushes and night sweats (HF/NS). However, some women are unable to attend face-to-face sessions. This study investigates whether Self-Help CBT for HF/NS is as effective when rolled out to women living at a distance with minimal telephone guidance. Study design: Forty-seven women completed a Self-Help CBT intervention (booklet and relaxation/paced breathing CD) during a 4-week period. They also received one ‘guiding’ telephone call from a clinical psychologist two weeks into treatment to provide support and discuss individual treatment goals. Questionnaires were collected at baseline, 6 weeks (post-treatment) and 3 months (follow-up) after the end of the intervention. Main outcome measures: HF/NS problem rating. Secondary outcome measures: HF/NS frequency, HF/NS beliefs and behaviours, sleep, anxiety and depressed mood. Results: There was a significant reduction in HF/NS problem-rating following the intervention which was maintained at follow-up. Moreover, women reported less frequent HF/NS along with further improvements in sleep quality, mood and HF/NS beliefs and behaviours. Conclusions: Telephone-guided Self-Help interventions might provide an effective way of widening access to CBT treatment for HF/NS. © 2013 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Cognitive Behavioural Therapy (CBT) has been found to reduce the impact of hot flushes and night sweats (HF/NS) in recent randomised controlled trials (MENOS 1 and MENOS 2) with well women and breast cancer patients [1,2]. HF/NS are the cardinal symptoms of the menopause transition and can negatively impact on sleep, mood and quality of life [3,4]. Guided Self-Help CBT was found to be as effective as Group CBT in reducing HF/NS problemrating or interference [1] and may be offered in order to widen access to treatment for women experiencing troublesome symptoms. Indeed, use of Self-Help formats has been found to be a cost-effective method of delivering treatments for anxiety and depression [5]. The UK National Health Service (NHS) also recognises that Self-Help CBT and other self-management interventions play an important role in addressing health inequalities in chronic symptom management [5,6]. Typically, guided Self-Help consists of a psychological intervention involving the patient taking home a standardised psychological manual in a written format (e.g. in a booklet, downloadable pdf
∗ Corresponding author. Tel.: +44 207 188 0180. E-mail address: [email protected] (M.S. Hunter). 0378-5122/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.maturitas.2013.09.013
etc.) and working through it in an independent manner [7,8]. Using step-by-step instructions, patients can learn how to apply a generally accepted psychological treatment to address their own needs; moreover, minimal time is required by a therapist, whose role is primarily supportive in helping the patient to work through the treatment her/himself. Therapist input tends to be maintained at a fairly minimal level by brief face-to-face contact, telephone, email or other communication methods [5]. However, guided Self-Help interventions often come in many forms and with different levels and types of therapist input, which may have significant implications for the costs of the treatments or their effectiveness [9]. For instance, although strong associations between higher levels of therapist input and better health-related outcomes have been reported [9], a recent meta-analysis suggested comparable outcomes between guided Self-Help and face-to-face interventions for anxiety and mood disorders; consequently, the authors argued that it may not be so much the intensity of therapist input (e.g. type, number or length of sessions) that makes a difference, but rather having contact between the two people in itself [5]. A CBT treatment for menopause-related HF/NS was developed based on a theoretical model of HF/NS, which outlines specific components (e.g. biological, psychological and social factors) and how these might influence women’s experiences of HF/NS [10,11]. In
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the MENOS 2 trial [1], women received CBT in a Self-Help format (i.e. booklet and relaxation/paced breathing CD) and had two contacts with a therapist: one face-to-face session during which the CBT approach was explained and a guiding phone call 2 weeks into treatment. Women reported significantly less problematic HF/NS compared to no-treatment controls at the end of intervention, which remained significant at 6 months follow-up [1]. During qualitative interviews carried out after the end of follow-up assessments, women reported finding the Self-Help approach beneficial [12]. Nevertheless, some women were unable to participate or attend face-to-face sessions due to travelling distance. This study investigates whether a guided Self-Help CBT intervention for HF/NS can be as effective as MENOS 2 Self Help CBT [1] when rolled out to women living at a distance with minimal telephone guidance. Findings are therefore discussed in relation to MENOS 2 data. HF/NS problem rating at post-treatment was selected as the most appropriate primary outcome measure because it is associated with reduced quality of life [4,13,14]. Secondary outcome measures included HF/NS frequency, beliefs and behavioural reactions towards HF/NS, sleep, anxiety and depressed mood. 2. Methods 2.1. Participants Women with variable menstrual cycles (menopause transition) or who were more than one year from their last menstrual period (post-menopause) with problematic HF/NS were recruited from websites and newspaper advertisements. Inclusion criteria: English speaking women, 18 years old or older, having problematic HF/NS (score > 2 on the Hot Flush Rating Scale (HFRS)) [11] for at least 1 month and minimum frequency of 10 flushes per week) and unable to attend for face-to-face interviews (e.g. living outside London) [1]. Exclusion criteria: non English speaking women and/or with history of medical or psychiatric conditions that would affect their ability to participate. 2.2. Procedure Potential participants were initially contacted by telephone for a screening assessment, which included an eligibility check and an explanation of the research procedure. If eligible and interested, they were sent information together with a consent form and assessment questionnaires, which they completed and returned to the research team using a freepost envelope. On receipt of the questionnaires and signed consent forms, the intervention was sent out. Another set of questionnaires was sent out at 6 weeks (posttreatment) and again at 3 months (follow-up) after the end of the intervention. Ethical approval was obtained from Kings College London Research Ethics Committee (Psychiatry, Nursing and Midwifery Research Ethics Subcommittee, reference: PNM/08/09-42). All participants gave written informed consent before taking part. 2.3. Intervention The intervention included psychoeducation, paced breathing and relaxation, and CBT to help women to manage HF/NS [1,15]. The intervention has been shown to be acceptable to women and has shown effectiveness in randomised clinical trials of Self-Help and group CBT [1,2]. It is based on a cognitive behavioural model of HF/NS that describes how a range of psychological factors might influence the physiological mechanisms as well as women’s perception and appraisal of HF/NS [10]. The model includes four stages
of HF/NS experience: physiological processes, symptom perception, cognitive appraisal and behavioural reactions to symptoms. Research examining the cognitive appraisals of HF/NS suggests that negative thoughts and beliefs about HF/NS are associated with problematic HF/NS, whereas calm thoughts, accepting the symptoms and not over-reacting, are associated with less problematic symptoms [10,16]. Negative attitudes to menopause have been found to be correlated with negative beliefs about HFNS [16], and depressed mood and anxiety have been found to be associated with more problematic HFNS. Self-Help CBT included a booklet completed over a four-week period. The content of Self-Help CBT was identical to a Group CBT intervention delivered in previous trials [1,2] with participants receiving a relaxation/paced breathing CD for daily practice and completing weekly homework tasks (e.g. daily diaries of their HF/NS so that they could monitor their own progress). The booklet also included interactive exercises with space for participants to write relevant information. The booklet content has been described previously: week 1 introduced participants to the CBT model of HF/NS and stress; week 2 introduced cognitive and behavioural strategies for dealing with HF; week 3 focused on managing NS and sleep and during week 4 participants reviewed individual goals and developed a maintenance plan (for more detailed information see [1,15]). Telephone guiding consisted of a telephone call from a clinical psychologist 2 weeks into treatment to provide support and discuss individual treatment goals. The psychologist discussed participants’ progress in reading through the materials and practising the exercises (e.g. cognitive and behavioural strategies, relaxation and breathing exercises). Possible barriers were identified (e.g. time constraints) and practical strategies to overcome these were considered. Telephone guiding lasted on average 25 min (range 15–35 min). Women were also provided with the contact details of the clinical psychologist in case they wished to gain clarification regarding anything they did not understand. 2.4. Measures Sociodemographic information, menopausal status, health and lifestyle questions were included with the following standardised questionnaires. The Hot Flush Rating Scale (HFRS) [11] is a self-report measure of HF/NS frequency and problem-rating over the past week. Problemrating is calculated as the mean of the scores on three Likert scales (scores range from 1–10) assessing the extent to which HF/NS are problematic, distressing and causing interference in daily life. Higher scores indicate more problematic HF/NS whereas a 2-point change on the scale is considered clinically significant. The scale has shown good test–retest reliability and concurrent validity. The Hot Flush Beliefs Scale (HFBS) [16] is a 27-item questionnaire, which assesses women’s beliefs about their HF/NS. It consists of three sub-scales (scores range from 0–5) reflecting negative beliefs about (i) hot flushes in a social context, (ii) coping/control over HF/NS and (iii) coping with night sweats and sleep. Higher scores indicate more negative beliefs. Internal consistency of the subscale items ranged between 0.78 and 0.93 and test–retest reliability ranged between 0.74 and 0.78. The Hot Flush Behaviour Scale (HFBehS) [17] is an 11-item questionnaire that measures behavioural strategies used to deal with HF/NS. It consists of three subscales (scores range from 0–5) assessing (i) behavioural avoidance, (ii) practical cooling behaviours and (iii) positive behavioural strategies. The scale has shown adequate internal consistency and concurrent criterion validity. The Women’s Health Questionnaire (WHQ) [18] is a reliable tool in assessing women’s perceptions of emotional and physical health
E. Stefanopoulou, M.S. Hunter / Maturitas 77 (2014) 73–77 Table 1 Sample characteristics: mean (standard deviation) or percentage %.
7
Telephone-guided CBT (N = 47)
Control (MENOS 2) Self-Help (MENOS 2)
6
Telephone-Guided Self-Help
54.82 ± 6.81 (44–77) 93.6 2.1 4.3 30.4 69.6
5 PROBLEM RATING SCORES
Age (years) Mean ± SD (range) Ethnicity % White Asian Black Menopausal status % Post-menopausal Perimenopause BMI Average weight Overweight or obese Surgical menopause % Oophorectomy Hysterectomy Marital status % Single Married/with a partner Divorced/Separated/Widowed Educational level % University/higher education School education (up to 18 year) No formal qualification Employment status % Full time Part time Not employed/Retired Smoking status % Current smoker Ex-smoker Never smoked Exercise % Rarely/never ≤1/week 2–6/week Daily Alcohol % 0–6 units 7–13 units 14+units
75
4
3
48.9 51.1
2
6.4 8.5
1
8.5 76.6 14.9
0
53.2 42.5 4.3 51.1 25.5 23.4 8.5 27.7 63.8 8.5 27.7 44.7 19.1 68.1 21.3 10.6
and has shown reasonable concurrent validity. Sleep, depressed mood and anxiety were the three subscales used in this study. 2.5. Data analysis Based on our previous findings a sample size of 40 has 90% power to detect a clinically relevant difference in mean HF/NS problem rating of 2 points, allowing for baseline value (estimated to have a mean of 5 and SD of 2.4) and a correlation between baseline and posttreatment values of 0.4 (giving a correction factor of 0.84) with two-sided significance level of 0.05 [1,2]. All analyses were completed in SPSS 18.0. Possible differences in outcome measures between (a) baseline and post-treatment and (b) baseline and follow-up were examined using paired samples t-tests. Between groups analyses were conducted on the primary outcome (i.e. problem rating scores at post-treatment) comparing the current sample with the no treatment control arm of the MENOS 2 trial (n = 45) using difference scores and baseline scores as a covariate. 3. Results 3.1. Sample characteristics Sample characteristics are presented in Table 1. Fifty-six women expressed interest in the study and forty-seven women met the inclusion criteria. The sample (n = 47) had a mean age of 54.82 (SD 6.81), ranging from 44 to 77 years old; 30% were perimenopausal
Baseline
Post-treatment TIME
Follow-up
(3 months for Telephone Self-Help CBT; 6 months for MENOS2 trial)
Fig. 1. HF/NS Problem rating mean scores at baseline, post-treatment and followup for Telephone-Guided (T-G) Self-Help CBT with MENOS2 Self-Help and control groups for comparison.
and 70% postmenopausal. The majority were white, married or cohabiting; educational level was fairly evenly divided between those educated up to and more than 18 years and three quarters were in employment. They drank on average between 0 and 6 units of alcohol per week (68.1%); 4 women were current cigarette smokers and 13 past smokers. They tended to be slightly overweight (mean body mass index (BMI) = 25.56, SD = 3.76) and 63% exercised regularly (a least twice a week). 34% of women had sought help from their GP/hospital doctor for their menopausal symptoms; 12% had used hormone replacement therapy (HRT) in the past and 6% were current users but were still symptomatic with problematic HF/NS. 3.2. Baseline measures Women estimated they were having on average 55 (SD 38.34) HF/NS per week. 44.21 (SD 34.97) were hot flushes and 15.44 (11.22) were night sweats. Average duration of HF/NS was 6.14 years (ranging from 4 months to 33 years; SD 7.47 years) and the mean HF/NS problem-rating scores were 6.23 (SD 2.16; range 1–10), reflecting frequent, chronic and moderately problematic HF/NS. Baseline WHQ, HFBS and HFBehS scores are presented in Table 2; scores were very similar to baseline MENOS 2 baseline data [1]. 3.3. Primary and secondary outcomes 3.3.1. Hot flushes and night sweats Compared to baseline, women reported a significant reduction in both the problem-rating scores (t (38) = 5.88, p < 0.0001) and frequency of HF/NS per week (t (40) = 3.42, p = 0.001) at posttreatment (see Table 2). At follow-up, women reported mean HF/NS problem-rating of 2.98 (SD 1.36) and 28.54 (SD 27.55) HF/NS per week. Differences from baseline for problem rating (t (31) = 7.40, p < 0.0001) and frequency (t (32) = 3.31, p = 0.002) remained significant at 3 months follow-up. Furthermore, the percentage of women reporting a clinically significant improvement greater than a 2-point reduction from baseline on the HF/NS problem rating scale was 63% (95% CI, 48–78) at post-treatment and 70% (95% CI, 54–86) at follow-up, respectively. The figures depict the mean problem rating scores (Fig. 1),
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E. Stefanopoulou, M.S. Hunter / Maturitas 77 (2014) 73–77
Table 2 Questionnaire scores at baseline, post-treatment and follow-up for telephone-guided CBT group. Telephone Guided CBT Mean (SD)
Hot Flush Rating Scale Frequency Problem rating Women’s Health Questionnaire Depressed mood Anxiety Sleep Hot Flush Beliefs Scale Beliefs about social context Hot flush coping/control Night sweats/sleep Hot Flush Behaviours Scale Cooling behaviours Positive coping Avoidance
Baseline
Post-treatment
Follow-up
55.52 (38.34) 6.23 (2.16)
37.85 (30.33)** 3.74 (1.87)**
28.54 (27.55)** 2.98 (1.36)**
0.32 (0.26) 0.46 (0.29) 0.65 (0.31)
0.21 (0.24)* 0.33 (0.25)** 0.52 (0.34)*
0.16 (0.19)** 0.24 (0.27)** 0.51 (0.36)**
2.60 (1.19) 2.84 (0.98) 2.59 (0.96)
2.04 (1.04)** 2.17 (0.75)** 2.04 (1.06)**
1.44 (0.85)** 1.80 (0.72)** 1.83 (0.99)**
3.53 (1.37) 2.61 (1.02) 1.41 (1.06)
3.51 (1.25) 3.47 (0.93)** 1.01 (0.92)*
3.37 (1.25) 3.84 (0.83)** 0.81 (0.79)**
*p < 0.05, **p < 0.01 (paired t-tests from baseline).
and the percentages of participants with a clinically significant improvement from baseline of 2 points on the same scale (Fig. 2); data from Self-Help CBT and no-treatment control group (MENOS 2 trial) are also included for comparison. Further analysis was conducted on the primary outcome (i.e. difference in problem rating scores between baseline and posttreatment) comparing women in this study with the no treatment control arm of the MENOS2 trial [1]. We found significant group differences on problem rating scores (F [1,79] = 13.38, p < 0.0001), with the telephone-guided Self-Help reporting fewer problematic flushes at post-treatment (mean [SD] difference scores 2.37 [2.52] than the no treatment control group 0.77 [1.56]; adjusted mean difference 1.40; 95% CI, 0.64–2.16). 3.3.2. Mood, HF/NS beliefs and behaviours Compared to baseline, participants reported a significant increase in positive coping (t (37) = −4.89, p < 0.0001) and reductions in avoidance (t (37) = 2.30, p = 0.02) behaviour scores (HFBehS) at post-treatment; scores in safety behaviours did not change significantly from baseline. Similarly, reductions were reported in negative beliefs (HFBS) about experiencing flushes in a social context (t (37) = 3.62, p = 0.001), coping/control (t (38) = 4.04, p < 0.0001) and night sweats/sleep (t (40) = 3.34, p = 0.002) subscales. In terms of WHQ scores, there were significant reductions in depressed mood (t (40) = 2.63, p = 0.01), anxiety (t
Fig. 2. Percentages of participants with a clinically significant improvement from baseline of 2 points on the HF/NS Problem Rating Scale at post-treatment and followup for telephone-guided Self-Help compared with MENOS 2 groups (self-help CBT, and no treatment control).
(40) = 3.10, p = 0.004) and sleep (t (40) = 2.26, p = 0.02) subscales. All differences from baseline remained statistically significant at follow-up (p < 0.05 for all comparisons). 4. Discussion This study aimed to investigate whether a Self-Help CBT intervention for HF/NS can be as effective when rolled out to women living at a distance with minimal telephone guidance, compared to outcomes obtained in the setting of a randomised controlled trial which included face to face contact [1]. In doing so, we wished to make the intervention more widely accessible to women who were not able to attend face-to-face sessions. Telephone-guided Self-Help CBT produced clinically significant changes in HF/NS problem rating (approximately 40% reduction in problem rating scores) at post-treatment which also remained significant at 3 month follow-up. This level of improvement is comparable to the MENOS 2 results (approximately 49% reduction in scores for Self-Help group at post-treatment) [1]. Moreover, 63% of telephone-guided Self-Help and 73% of MENOS 2 Self-Help CBT participants reported a clinically significant improvement of 2 points or more on the HF/NS problem rating scale at post-treatment whilst changes were maintained at follow-up (70% and 72%, respectively). Statistical analysis comparing this telephone guided intervention with the MENOS 2 no treatment control group showed significant group differences in the primary outcome (problemrating at post treatment), which is consistent with MENOS 2 outcomes. Similarly, women reported less frequent symptoms at post-treatment and follow-up along with further improvements in sleep quality, mood as well as positive changes in HF/NS beliefs and behaviours. Taken together, findings from this study appear to support the view that the mode of therapist input might not have a significant effect on treatment outcome [5,19]. However, there is some evidence that guided Self-Help is more effective than unguided Self-Help for the treatment of anxiety and depression [20,21]. In the current study women received the same content of treatment as in previous trials [1,2] but this was delivered face by a single telephone guiding session only. In the MENOS 1 and 2 trials, participants had an initial face-to-face interview with a clinical psychologist explaining the treatment plus a telephone guiding session [1,2]. Moreover, in the current study, although women were provided with the contact details of the clinical psychologist, none of the participants contacted the therapist to discuss the materials (booklet, CD) further. It is possible that the brief contact with the therapist, rather than the intensity of such input, might
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influence outcome [5], but also that the Self Help CBT booklet alone is sufficient for women to manage their menopausal symptoms. Guided versus unguided CBT for HF/NS could be tested in future research. Future research might usefully explore preferences for modes of delivery of CBT, such as guided Self-Help or computerised CBT or Group CBT [22]. In the MENOS 2 trial, women who received Group CBT did obtain more general improvements in mood and quality of life than those who received Self-Help CBT, even though findings were remarkably similar for the main outcome (HF/NS problem rating) [1]. Similarly, further research is warranted to evaluate the acceptability and efficacy of Self-Help CBT with women from more culturally diverse backgrounds, since our sample comprised mostly of white British, reasonably well-educated participants. In terms of other limitations, we only included a three month post treatment follow up period in this study, rather than the six month post randomisation follow up in MENOS 2 – a difference of 2 months as treatment was over one month. No control group was included in this study and therefore we cannot determine whether improvements occurred because of the CBT intervention only. However, we were able to compare this sample with the control arm of the MENOS 2 trial. We tested a naturalistic roll out of the intervention and found that the results are broadly comparable to those obtained in the context of a randomised controlled trial. In terms of clinical implications, it is possible that this Self-Help CBT intervention might also help to alleviate cancer treatmentrelated HF/NS which are prevalent and troublesome for breast cancer survivors [2], as well as for men experiencing problematic HF/NS following hormone treatments for prostate cancer [23]. 5. Conclusions Findings from the current study suggest that telephone-guided Self-Help CBT might be an effective way of delivering an intervention for HF/NS for women who have difficulty in accessing face-to-face CBT. However, Group CBT might be considered for those who prefer a group format or who have low mood and/or quality of life. Ideally a choice of formats could be offered. Contributors MSH was the principal investigator of the study; ES carried out the guided self-help intervention and both authors prepared and approved the final manuscript. Competing interest None. Funding None.
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Acknowledgements We would like to thank Eleanor Mann and Rowena Barber for their help with data collection in the early stages of this study. References [1] Ayers B, Smith M, Hellier J, Mann E, Hunter MS. Effectiveness of group and Self-Help Cognitive Behavior Therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. Menopause 2012;19:749–59. [2] Mann E, Smith MJ, Hellier J, Balabanovic JA, Hamed H, Grunfeld EA, Hunter MS. Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncol 2012;13:309–18. [3] Archer DF, Sturdee DW, Baber R, et al. Menopausal hot flushes and night sweats: where are we now. Climacteric 2011;14:515–28. [4] Ayers B, Hunter MS. Health-related quality of life of women with menopausal hot flushes and night sweats. Climacteric 2013;16:235–9. [5] Cuijpers P, Donker T, Van Straten A, Li J, Andersson G. Is guided Self-Help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010;40, 1943-57. [6] Department of Health. Research evidence on the effectiveness of self care support. London: Stationery Office; 2007. [7] Marrs RW. A meta-analysis of bibliotherapy studies. Am J Community Psychol 1995;23:843–70. [8] Cuijpers P, Schuurmans J. Self-Help interventions for anxiety disorders: an overview. Curr Psychiatry Rep 2007;9:284–90. [9] Palmqvist B, Carlbring P, Andersson G. Internet-delivered treatments with or without therapist input: does the therapist factor have implications for efficacy and cost. Expert Rev Pharmacoecon Outcomes Res 2007;7:291–7. [10] Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res 2010;69:491–501. [11] Hunter MS, Liao KLM. A psychological analysis of menopausal hot flushes. Br J Clin Psychol 1995;34:589–99. [12] Balabanovic J, Ayers B, Hunter MS. Cognitive behaviour therapy for menopausal hot flushes and night sweats: a qualitative analysis of women’s experiences of group and Self-Help CBT. Behav Cogn Psychoth 2012;1:1–17. [13] Hunter MS, Rendall M. Bio-psycho-socio-cultural perspectives on menopause. Best Pract Res Clin Obstet Gynaecol 2007;21:261–74. [14] Rand KL, Otte JL, Flockhart D, et al. Modeling hot flushes and quality of life in breast cancer survivors. Climacteric 2011;14:171–80. [15] Hunter MS, Smith M. Managing Hot Flushes and Night Sweats: A Cognitive Behavioural Guide to Menopause. Sussex, UK: Routledge; 2013. [16] Rendall MJ, Simonds LM, Hunter MS. The Hot Flush Beliefs Scale: a tool for assessing thoughts and beliefs associated with the experience of menopausal hot flushes and night sweats. Maturitas 2008;60:158–69. [17] Hunter MS, Ayers B, Smith M. The Hot Flush Behavior Scale: a measure of behavioral reactions to menopausal hot flushes and night sweats. Menopause 2011;18:1178–83. [18] Hunter MS. The Women’s Health Questionnaire: a measure of mid-aged women’s perceptions of their emotional and physical health. Psychol Health 1992;7:45–54. [19] Andersson G, Carlbring P, Grimlund A. Predicting treatment outcome in Internet versus face to face treatment of panic disorder. Comput Hum Behav 2008;24:1790–801. [20] Knaevelsrud C, Maercker A. Internet-based treatment for PTSD reduces distress and facilitates the development of a strong therapeutic alliance: a randomized controlled clinical trial. BMC psychiatry 2007;7:13–23. [21] Hirai M, Clum GA. A meta-analytic study of Self-Help interventions for anxiety problems. Behav Ther 2006;37:99–111. [22] Spek V, Cuijpers PIM, Nyklícek I, Riper H, Keyzer J, Pop V. Internet-based 417 cognitive behaviour therapy for symptoms of depression and anxiety: a metaanalysis. Psychol Med 2007;37:319–28. [23] Yousaf O, Stefanopoulou E, Grunfeld EA, Hunter MS. A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN): trial protocol. BMC Cancer 2012;12:230–7.
