Menopause: The Journal of The North American Menopause Society Vol. 21, No. 6, pp. 574/578 DOI: 10.1097/gme.0000000000000095 * 2013 by The North American Menopause Society

Cognitive-behavior therapy for menopausal symptoms (hot flushes and night sweats): moderators and mediators of treatment effects Sam Norton, PhD, Joseph Chilcot, PhD, and Myra S. Hunter, PhD Abstract Objective: Cognitive-behavior therapy (CBT) has been found in recent randomized controlled trials (MENOS1 and MENOS2) to reduce the impact of hot flushes and night sweats (HFNS). In the MENOS2 trial, group CBT was found to be as effective as self-help CBT in reducing the impact of HFNS. This study investigates for whom and how CBT works for women in the MENOS2 trial. Methods: This study performed a secondary analysis of 140 women with problematic HFNS who were recruited to the MENOS2 trial: 48 were randomly assigned to group CBT, 47 were randomly assigned to self-help CBT, and 45 were randomly assigned to usual care. Self-report questionnaires were completed at baseline, 6 weeks postrandomization, and 26 weeks postrandomization. Potential moderators and mediators of treatment effects on the primary outcomeVhot flush problem ratingVwere examined using linear mixed-effects models and path analysis, respectively. Results: CBT was effective at reducing HFNS problem rating regardless of age, body mass index, menopause status, or psychological factors at baseline. Fully reading the manual in the self-help CBT arm and completing most homework assignments in the group CBT arm were related to greater improvement in problem rating at 6 weeks. The effect of CBT on HFNS problem rating was mediated by changes in cognitions (beliefs about coping/control of hot flushes, beliefs about night sweats and sleep) but not by changes in mood. Conclusions: These findings suggest that CBT is widely applicable for women having problematic HFNS, regardless of sociodemographic or health-related factors, and that CBT works mainly by changing the cognitive appraisal of HFNS. Key Words: Menopause Y Vasomotor symptoms Y Hot flushes Y Cognitive-behavior therapy Y Mediator Y Moderator.

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ot flushes and night sweats (HFNS) are commonly experienced during the menopausal transition and postmenopause1,2 and are problematic for approximately 25% of women largely because of embarrassment, physical discomfort, and sleep disruption, and their impact on quality of life.3,4 There has been considerable interest in the development of effective nonmedical interventions to help women manage menopausal symptoms5 and growing evidence from three recent randomized controlled trials that cognitive-behavior therapy

Received June 26, 2013; revised and accepted August 8, 2013. From the Institute of Psychiatry, King’s College London, London, UK. M.S.H. conceptualized and designed the study. J.C. and S.N. analyzed and interpreted the data. All authors contributed to the writing of the manuscript and approved its final version. Funding/support: This study was supported by the National Institute for Health Research Biomedical Research Center for Mental Health, South London and Maudsley NHS Foundation Trust, and the Institute of Psychiatry, King’s College London. Financial disclosure/conflicts of interest: None reported. Address correspondence to: Myra S. Hunter, PhD, Health Psychology Section, Fifth Floor Bermondsey Wing, Guy’s Campus, King’s College London, London SE1 9RT, UK. E-mail: [email protected]

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(CBT) can effectively reduce the impact of HFNS on well women6 and women who have had breast cancer.7,8 These trials used group CBT (four to six weekly sessions of CBT; 8 h in total) based on the model developed by Hunter and Liao,9 Hunter et al,10 and Hunter and Mann.11 The MENOS2 trial compared group CBT versus self-help CBT versus no treatment6,12 and included both subjective and physiological measures (sternal skin conductance [SSC]) of hot flushes and a measure of problem rating or bothersomeness.13 Problem rating is the most clinically relevant measure because it is associated with impact on quality of life4 and was measured using the Hot Flush Rating Scale (HFRS).13 CBT was effective in reducing the impact, or problem rating, of hot flushes and had additional benefits on mood and quality of life.5 In a further analysis of physiological SSC data using a revised pattern recognition software (Bahr monitor, software version 1.1.6, January 2012), we found a small but significant reduction in hot flush frequency for CBT groups compared with controls, suggesting that CBT might affect both physiological and subjective outcome measures.14 A key issue when researching complex interventions is to attempt to clarify which components of the interventions are

Menopause, Vol. 21, No. 6, 2014

Copyright © 2014 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.

MODERATORS AND MEDIATORS OF CBT

important (ie, to understand how CBT is working).6 We hypothesize that CBT works by changing overly negative beliefs, by helping women to use behavioral strategies (such as paced breathing), and, possibly, by impacting on physiological and psychological processes.11,14

Cognitive-behavior therapy for menopausal symptoms (hot flushes and night sweats): moderators and mediators of treatment effects.

Cognitive-behavior therapy (CBT) has been found in recent randomized controlled trials (MENOS1 and MENOS2) to reduce the impact of hot flushes and nig...
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