Journal of Mental Health
ISSN: 0963-8237 (Print) 1360-0567 (Online) Journal homepage: http://www.tandfonline.com/loi/ijmh20
Activity groups for people with schizophrenia: a randomized controlled trial Madeleine Dean, Adam R. W. Weston, David P. Osborn, Suzie Willis, Sue Patterson, Helen Killaspy, Baptiste Leurent & Mike J. Crawford To cite this article: Madeleine Dean, Adam R. W. Weston, David P. Osborn, Suzie Willis, Sue Patterson, Helen Killaspy, Baptiste Leurent & Mike J. Crawford (2014) Activity groups for people with schizophrenia: a randomized controlled trial, Journal of Mental Health, 23:4, 171-175 To link to this article: http://dx.doi.org/10.3109/09638237.2014.889285
Published online: 24 Mar 2014.
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Date: 05 November 2015, At: 18:13
http://informahealthcare.com/jmh ISSN: 0963-8237 (print), 1360-0567 (electronic) J Ment Health, 2014; 23(4): 171–175 ! 2014 Informa UK Ltd. DOI: 10.3109/09638237.2014.889285
ORIGINAL ARTICLE
Activity groups for people with schizophrenia: a randomized controlled trial Madeleine Dean1, Adam R. W. Weston1, David P. Osborn2, Suzie Willis3, Sue Patterson1, Helen Killaspy2, Baptiste Leurent4, and Mike J. Crawford1 1
Centre for Mental Health, Imperial College London, London, UK, 2Mental Health Sciences Unit, University College London, London, UK, Central and North West London NHS Foundation Trust, London, UK, and 4Department of Primary Care and Population Health, University College London, London, UK
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3
Abstract
Keywords
Background: UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. Aims: To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. Methods: Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). Results: About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score ¼ 6.0, 95% CI 2.3 to 9.8) but global functioning did not (change in GAF score ¼ 0.8, 95% CI 1.7 to 3.3). No significant differences were found between treatment arms. Conclusions: Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.
Activity group, schizophrenia, randomized controlled trial
Introduction Schizophrenia is a severe mental illness which affects up to 1.4% of people during their lifetime (Cannon & Jones, 1996). Negative symptoms of schizophrenia impair social functioning, are associated with reduced quality of life (Pfammatter et al., 2006) and increased likelihood of relapse and hospital admission (Couture et al., 2006). Pharmacological treatments have limited efficacy in treating negative schizophrenia symptoms (Conley & Buchanan, 1997). There is evidence that some psychosocial interventions are effective in conjunction with medication (Pfammatter et al., 2006). Social activity groups comprise a form of psychosocial intervention that is widely available in mental health services in the UK (Rogers & Pilgrim, 1993) but there is limited evidence available about their efficacy. A systematic review of the effectiveness of activity groups for people with mental disorders (Bullock & Bannigan, 2011) identified two trials which examined the effects of activity groups (DeCarlo &
History Received 28 August 2013 Revised 10 November 2013 Accepted 11 January 2014 Published online 24 February 2014
Mann, 1985; Schindler, 1999). Neither study examined the effects of activity groups for people with psychosis or measured the effect on mental health or general functioning. Nevertheless, the National Institute for Health and Clinical Excellence recommends that people with a diagnosis of schizophrenia have access to social activities throughout their care (National Collaborating Centre for Mental Health, 2010). The MATISSE study (Multicentre trial of Art Therapy In Schizophrenia: Systematic Evaluation) was a three-arm randomized controlled trial that investigated the efficacy of group art therapy plus standard care, activity groups plus standard care and standard care alone for people with a diagnosis of schizophrenia (Crawford et al., 2012). We undertook a secondary analysis of data from this trial. The aim was to investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone.
Method Correspondence: M. J. Crawford, Professor in Mental Health Research, Centre for Mental Health, Imperial College London, Claybrook Centre, 37, Claybrook Road, London W6 8LN, UK. Tel: +207 386 1233. Fax: +207 386 1216. E-mail: [email protected]
Participants and setting This analysis of the MATISSE project (ISRCTN: 46150447) included data from participants randomized to receive weekly
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activity groups or standard care alone. Participants were recruited from three centers in England and one in Northern Ireland. Centers were selected because they had systems for delivering group art therapy and for supervising arts therapists. The centers include a mix of inner city, urban, semi-rural and rural areas and serve a population of people from many different ethnic backgrounds. Participants were recruited from secondary care settings including day hospitals, community mental health teams, rehabilitation services, supported accommodation and day centers. Eligibility criteria were aged 18 years or older, living in the community and a clinical diagnosis of schizophrenia confirmed by OPCRIT (McGuffin et al., 1991). Exclusion criteria comprised severe cognitive impairment, inability to complete the assessments due to language difficulties and currently receiving any arts therapies. All participants provided written informed consent. The study was approved by Huntingdon Research Ethics Committee (06/Q0104/82) prior to data collection. Further details about the trial methods are reported elsewhere (Crawford et al., 2010). Measures Outcomes were assessed through an interview with the researchers at recruitment and 12 months later using standardized measures. The primary outcomes were mental health, assessed using the Positive And Negative Symptom Scale (PANSS) (Kay et al., 1987), and global functioning, assessed using the Global Assessment of Functioning (GAF) (Jones et al., 1995). Secondary outcomes were positive, negative and general symptoms sub-scales of the PANSS, social function assessed using the Social Function Schedule (Tyrer et al., 2005), wellbeing assessed using the General Well-Being Scale (Norman et al., 2000), and medication adherence assessed using the Morisky scale (George et al., 2000). Interventions The structure and content of the activity groups were based on those of groups commonly provided by mental health and social care services for people with psychosis in the UK. Groups had a maximum of eight members at one time and were run for up to 90 min, on a weekly basis over 12 months. Groups were run by two facilitators, at least one of whom had previous experience working with this patient group. The lead facilitator of each group received training prior to the start of the study and monthly supervision from a senior practitioner. Facilitators offered participants a range of activities including discussions, board games and visits to places of interest. Participants were encouraged to select activities and were allowed to spend up to £10 ($15) per session in expenses. Facilitators were asked not to offer creative activities, skills training, occupational therapy or psychotherapy. If participants expressed concerns about their mental health, facilitators were advised to encourage participants to seek help and advice from other mental health professionals involved in their care and not to explore thoughts and feelings to avoid delivering psychotherapeutic interventions.
J Ment Health, 2014; 23(4): 171–175
To assess treatment fidelity, facilitators completed a proforma at the end of a session to record group details including: the chosen activity, duration of attendance, management of any breaches of group boundaries and the response group facilitators made to any issues raised by attendees. These proforma were subsequently examined to check the content of groups and evidence of boundary breeches. Standard care comprised of usual contact and treatment from secondary mental health care services, including outpatient appointments, access to day care and inpatient treatment, treatment with medication and psychosocial interventions other than arts therapies. Procedures At each center researchers publicized the study through meetings with clinical staff. Potential participants who gave verbal consent to be contacted to clinical staff, met with a researcher who provided information, assessed eligibility and obtained written informed consent. Baseline assessments were conducted before randomization, which was undertaken by an independent remote telephone service provided by the Aberdeen Clinical Trials Unit. Permuted stacked blocks of three to six were used, stratified by site. An independent administrator advised participants, their mental health worker, general practitioner and if relevant the activity group facilitator, of their study arm allocation status. Group facilitators made concentrated efforts to engage with participants to encourage their attendance and retention in groups including contact by letter and phone, arranging a time to discuss the group and offering to meet up before a group to give details about it, answer any questions and discuss any concerns. Groups were held during normal working hours in clinics, day centers and other premises within the catchment area where participants lived. Researchers who carried out follow up interviews remained masked to allocation status. Participants were offered £15 ($22) honorarium for their time completing assessments. Data analysis All primary analyses were conducted using the intentionto-treat principle in SPSS Version 18.0. Analyses were performed on participants with complete data. Within group differences between baseline and 12 months and differences between treatment arms at 12 months were examined using appropriate t-tests. Differences in primary outcomes between those randomized to activity groups or standard care alone were then examined using linear regression adjusted for baseline value, gender and age. In subsequent analysis, we used two-stage least squares estimation of average causal effects in models with variable treatment intensity (Angrist & Imbens, 1995). This analysis estimates the effect of attending the activity groups for a person willing to attend. It assumes that the effect of allocation to treatment has no effect on the outcome if the patient does not receive the treatment. We estimated the benefit per session, assuming benefit to be proportional to the number of sessions attended, and adjusted for site, gender and age.
Activity groups for people with schizophrenia
DOI: 10.3109/09638237.2014.889285
Results
Primary and secondary outcomes
About 649 people were assessed between February 2007 to August 2008, of whom 584 (90%) were eligible (see Figure 1). Of these, 167 (28.7%) declined to take part, 140 were randomized to receive art therapy, 140 to receive activity groups and 137 to standard care alone. Characteristics of those randomized to activity groups or standard care alone are presented in Table 1. About 242 (87.4%) of these participants completed the 12-month assessment. Baseline characteristics of participants who did not complete the follow-up did not differ from those who did.
The unadjusted study outcomes at baseline and 12 months are presented in Table 2. Participants allocated to receive activity groups showed statistically significant improvements in all mental health symptom scores, wellbeing and medication
Uptake of and content of activity groups
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Of the 140 participants allocated to receive activity groups, 73 (52%) attended at least one session. The median time between randomization and attendance at the first group was 61.5 days. This delay was due to groups not being able to start until sufficient numbers of participants had been recruited to commence a group. Among those who attended the activity groups, the mean number of groups attended was 2.1 (SD ¼ 0.9). Group size varied from one to nine, with fluctuating attendance over the 12-month period. Examination of 443 activity groups proformas identified the following activities had been undertaken: 203 (45.8%) sessions involved excursions, 137 (30.9%) entailed playing games/sports, 76 (17.2%) were spent watching DVDS, 52 (11.7%) involved themed discussions, 21 (4.7%) were spent cooking, 21 (4.7%) entailed completing puzzles/ quizzes and two (0.5%) involved storytelling. There was no evidence that use of art materials or engagement in craft activities occurred and group boundaries were adhered to.
Table 1. Participant characteristics at baseline. Standard care n ¼ 137
Variable Center West London North London Avon and Wilshire Belfast Gender Male Female Mean age Ethnicity White British White Other Black Other Marital status Married/living as Divorced/separated/widowed Single Education Degree A-levels GCSE NVQ/vocational training None Median age at onset of psychosis (IQR)
Figure 1. Consort diagram.
44 38 33 22
Activity group n ¼ 140
(32%) (28%) (24%) (16%)
43 38 35 24
(31%) (27%) (25%) (17%)
Total n ¼ 277 87 76 68 46
(31%) (27%) (25%) (17%)
99 (72%) 90 (64%) 189 (68%) 38 (28%) 50 (36%) 88 (32%) 40 (SD 12) 42 (SD 12) 41 (SD 12) 76 25 27 9
(55%) (18%) (20%) (7%)
71 28 26 15
8 (6%) 12 (9%) 117 (85%) 18 14 40 22 35 20
(51%) (20%) (19%) (11%)
12 (9%) 22 (16%) 106 (76%)
(14%) (11%) (31%) (17%) (27%) (18–26)
15 21 43 13 46 22
(11%) (15%) (31%) (9%) (33%) (18–29)
147 53 53 24
(53%) (19%) (19%) (1%)
20 (7%) 34 (12%) 223 (81%) 33 35 83 35 81 21
(12%) (13%) (31%) (13%) (30%) (18–28)
Assessed for eligibility n=649
Excluded n=232 Not Eligible n= 65 Refused n=167
Randomised n=417 (Allocated to art therapy n = 140)
Allocated to standardcare n=137
Dropped out n=10 Died n=1 Lost to follow up n=5 Withdrawn n=4
12 months assessment n=121
Allocated to activity group n=140
Dropped out n=11 Died n=2 Lost to follow up n=7 Withdrawn n=2
12 months assessment n=121
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J Ment Health, 2014; 23(4): 171–175
Table 2. Unadjusted outcomes at baseline and 12-month assessment. Standard care
Outcomes
Baseline 12 months mean (SD) mean (SD)
PANSS total PANSS general PANSS positive PANSS negative Global functioning General wellbeing Social function schedule Medication adherence
71.8 36.8 17.2 18.4 44.6 64.5 8.1 1.2
(21.2) (11.3) (5.7) (7.5) (12.9) (20.4) (4.7) (1.3)
71.2 36.3 16.7 18.2 45.7 64.9 8.4 0.7
(24.6) (13.0) (6.3) (7.7) (14.4) (23.3) (4.9) (1.1)
Activity group Change (95% CI)
0.6 0.5 0.5 0.3 1.2 0.4 0.3 0.5
(4.2 (2.4 (1.6 (1.6 (1.2 (2.9 (0.6 (0.7
to to to to to to to to
3.0) 1.4) 0.6) 1.0) 3.5) 3.7) 1.2) 0.2)***
Baseline 12 months mean (SD) mean (SD) 75.8 38.4 18.4 18.6 44.7 59.1 8.8 1.1
(22.2) (12.0) (6.7) (6.8) (12.7) (19.2) (4.8) (1.2)
69.8 35.7 16.2 17.2 45.5 63.9 8.2 0.6
(23.0) (12.7) (5.9) (7.2) (14.1) (23.6) (4.7) (0.9)
Change (95% CI) 6.0 2.7 2.2 1.4 0.8 4.9 0.5 0.4
(9.8 to 2.3)** (4.7 to 0.6)* (3.3 to 1.1)*** (2.5 to 0.2)* (1.7 to 3.3) (0.8 to 9.0)* (1.5 to 0.4) (0.7 to 0.2)***
Mean difference between arms (95% CI) 1.9 (8.2 to 4.4) 0.5 (3.8 to 2.8) 0.6 (2.2 to 0.9) 0.9 (2.9 to 1.0) 0.2 (3.8 to 3.4) 0.8 (7.0 to 5.3) 0.4 (1.7 to 0.9) 0.02 (0.3 to 0.2)
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*p50.05, **p 0.01, ***p 0.001.
adherence between recruitment and 12-month assessment. Participants who received standard care alone showed improvement in medication adherence only. However, there were no significant differences in GAF score at 12 months between study arms (Difference ¼ 0.2, p ¼ 0.9), total PANSS score (Difference ¼ 1.9, p ¼ 0.6) or any of the secondary outcomes. When adjusted for baseline score, age and gender neither the total PANSS score (beta ¼ 0.1, p ¼ 0.07) or the GAF score (beta ¼ 0.01, p ¼ 0.9) were significant. The estimated average causal effect of attendance at activity groups in relation to total PANSS score was 0.5 (95% CI 1.2 to 0.2) at 12 months. That is, for every session a participant attended we found an average decrease of 0.5 in the PANSS Score that was not statistically significant. For global functioning, the estimated average causal effect of attendance at an activity groups was 0.08 (95% CI 0.5 to 0.4).
Discussion This secondary analysis reports on the efficacy of activity groups for patients with schizophrenia. Although there were improvements in mental health and wellbeing among those randomized to activity groups, between group comparisons failed to find a statistically significant difference. However, uptake and attendance at groups was poor. While improvements in mental health were found among those randomized to activity groups, it is possible that these differences arose due to unknown confounders, not the randomized groups. This study is the first to examine the effects of social activity groups on mental health or social functioning of people with schizophrenia in a large-scale randomized trial. Two previous trials examined the impact of activity groups on interpersonal skills (DeCarlo & Mann, 1985; Schindler, 1999). However, neither study examined mental health and social functioning. Other research has compared the effectiveness of activity groups with cognitive behavioral therapy, but the absence of an ‘‘inactive’’ control means that the impact of attending the activity groups could not be tested (Haddock et al., 2009). Previous trials of psychosocial interventions for people with schizophrenia have been shown to be effective in improving symptoms and functioning (Pfammatter et al.,
2006; Razali et al., 2000; Xia et al., 2011). Such interventions focus more directly on the symptoms of schizophrenia than activity groups. However, there is evidence that promoting activity may lead to improvements in social function through encouraging motivation and daytime structure (Cook & Howe, 2003). Levels of engagement in the activity group suggest that simply offering a place in an activity group is inadequate and service users are likely to require more proactive support to improve engagement. Strengths and limitations The major strengths of this study were the broad inclusion and narrow exclusion criteria, the masking of researchers to treatment allocation and the high follow-up rate. Groups were run by experienced staff who received regular supervision. Data from a parallel qualitative study supports findings from the review of study proforma that groups were delivered as they were intended and adhered to group boundaries (Patterson, 2010). However, this study has a number of limitations which need to be considered when interpreting the findings. Firstly, the findings presented in this paper are based on a secondary analysis of data from a larger study originally designed to test the efficacy of group art therapy for people with schizophrenia. The sample size for the original study was based on a primary hypothesis of the differences in global functioning between those randomized to group art therapy and standard care alone. However, with a total of 277 participants for the activity groups and standard care alone, we had sufficient power to detect clinically important differences in outcomes between those randomized to activity groups and standard care alone. A key finding was that attendance at activity groups was low. Reasons for non-attendance and drop out were explored in the integrated process evaluation (Patterson et al., 2012). There were several reasons participants stated including moving areas prior to the group starting, perceived wellness and practical issues such as transport. Additionally, unlike in previous trials of complex interventions when patients who received their preferred treatment were around half as likely to drop-out of treatment (Swift & Callahan, 2009) participants were more likely to attend if they received an intervention they desired but most of them were
DOI: 10.3109/09638237.2014.889285
not treatment seeking at all (Patterson, 2010). This suggests that low levels of attendance cannot be explained by participants having a strong preference for the other active intervention. Levels of attendance at group art therapy in the trial were also low (Crawford et al., 2012) suggesting that patient motivation and organizational skills which are known to be poor in people with schizophrenia (Johnstone et al., 2009; Killaspy et al., 2000) may have partially led to the low level of attendance at groups. There was a statistically significant reduction in schizophrenia symptoms scores within the activity group arm. This does not provide evidence that the activity group treatment was more effective than standard care alone (Bland & Altman, 2011). This finding indicates that further research in this area is needed to help understand if and how participation in activity groups may lead to changes in mental health and social functioning.
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Implications for future research The findings of this study highlight the weakness of the evidence base for the effectiveness of activity groups for people with psychosis. The low level of attendance at the groups suggests that further effort needs to be made to evaluate factors that influence attending activity groups and to develop new approaches to engage people with psychosis in social activities. Further qualitative research may help to understand service user experiences of using social groups and help design new approaches to engage people. We did not find evidence that activity group treatment has a positive effect on mental health symptoms, global functioning or any of our secondary outcomes. However, within group differences among those allocated to activity groups supports future research in this area. Further research needs to be undertaken to understand about how to engage people with psychosis in social activities and clinical trials examining the outcomes of these interventions if, recommendations that these interventions for people with a diagnosis of schizophrenia are to be sustained.
Acknowledgements The MATISSE study was supported by the NIHR Technology Assessment Programme. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR or the Department of Health. All authors critically reviewed this paper.
Declaration of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
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Cannon M, Jones P. (1996). Schizophrenia. J Neurol Neurosurg Psychiatry, 60, 604–13. Conley RR, Buchanan RW. (1997). Evaluation of treatment-resistant schizophrenia. Schizophr Bull, 23, 663–74. Cook S, Howe A. (2003). Engaging people with enduring psychotic conditions in primary mental health care and occupational therapy. Br J Occup Ther, 66, 236–46. Couture SM, Penn DL, Roberts DL. (2006). The functional significance of social cognition in schizophrenia: A review. Schizophr Bull, 32, S44–63. Crawford M, Killaspy H, Barnes TRE, et al. (2012). Group art therapy as an adjunctive treatment for people with schizophrenia: Multicentre pragmatic randomised trial. Br Med J, 344, e846. Crawford M, Killaspy H, Kalaitzaki E, et al. (2010). The MATISSE study: A randomised trial of group art therapy for people with schizophrenia. BMC Psychiatry, 10, 65. DeCarlo JJ, Mann WC. (1985). The effectiveness of verbal versus activity groups in improving self-perceptions of interpersonal communication skills. Am J Occup Ther, 39, 20–7. George CF, Peveler RC, Heiliger S, Thompson C. (2000). Compliance with tricyclic antidepressants: The value of four different methods of assessment. Br J Clin Pharmacol, 50, 166–71. Haddock G, Barrowclough C, Shaw JJ, et al. (2009). Cognitivebehavioural therapy v. social activity therapy for people with psychosis and a history of violence: Randomised controlled trial. Br J Psychiatry, 194, 152–7. Johnstone R, Nicol K, Donaghy M, Lawrie S. (2009). Barriers to uptake of physical activity in community-based patients with schizophrenia. J Ment Health, 18, 523–32. Jones SH, Thornicroft G, Coffey M, Dunn G. (1995). A brief mental health outcome scale-reliability and validity of the Global Assessment of Functioning (GAF). Br J Psychiatry, 166, 654–9. Kay SR, Fiszbein A, Opler LA. (1987). The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull, 13, 261–76. Killaspy H, Banerjee S, King M, Lloyd M. (2000). Prospective controlled study of psychiatric out-patient non-attendance: Characteristics and outcome. Br J Psychiatry, 176, 160–5. McGuffin P, Farmer A, Harvey I. (1991). A polydiagnostic application of operational criteria in studies of psychotic illness: Development and reliability of the opcrit system. Arch Gen Psychiatry, 48, 764–70. National Collaborating Centre for Mental Health. (2010). Schizophrenia: Core interventions in the treatment and management of schizophrenia in adults in primary and secondary care. (Updated ed.). Leicester & London: The British Psychological Society and The Royal College of Psychiatrists. Norman RM, Malla AK, McLean T, et al. (2000). The relationship of symptoms and level of functioning in schizophrenia to general wellbeing and the Quality of Life Scale. Acta Psychiatr Scand, 102, 303–9. Patterson S. (2010). Evidence for mental health care: A grounded theory reconstruction of the randomised controlled trial. PhD. London: Imperial College. Patterson S, Borschmann R, Waller DE. (2012). Considering referral to art therapy: Responses to referral and experiences of participants in a randomised controlled trial. Int J Art Ther, 18, 2–9. Pfammatter M, Junghan UM, Brenner HD. (2006). Efficacy of psychological therapy in schizophrenia: Conclusions from meta-analyses. Schizophr Bull, 32, S64–80. Razali SM, Hasanah CI, Khan A, Subramaniam M. (2000). Psychosocial interventions for schizophrenia. J Ment Health, 9, 283–9. Rogers A, Pilgrim D. (1993). Service users’ views of psychiatric treatments. Sociol Health Ill, 15, 612–31. Schindler VP. (1999). Group effectiveness in improving social interaction skills. Psychiatr Rehabil J, 22, 349–54. Swift JK, Callahan JL. (2009). The impact of client treatment preferences on outcome: A meta-analysis. J Clin Psychol, 65, 368–81. Tyrer P, Nur U, Crawford M, et al. (2005). The Social Functioning Questionnaire: A rapid and robust measure of perceived functioning. Int J Soc Psychiatry, 51, 265–75. Xia J, Merinder LB, Belgamwar MR. (2011). Psychoeducation for schizophrenia. Cochrane Database Syst Rev, 6, CD002831.
ISSN: 0963-8237 (Print) 1360-0567 (Online) Journal homepage: http://www.tandfonline.com/loi/ijmh20
Activity groups for people with schizophrenia: a randomized controlled trial Madeleine Dean, Adam R. W. Weston, David P. Osborn, Suzie Willis, Sue Patterson, Helen Killaspy, Baptiste Leurent & Mike J. Crawford To cite this article: Madeleine Dean, Adam R. W. Weston, David P. Osborn, Suzie Willis, Sue Patterson, Helen Killaspy, Baptiste Leurent & Mike J. Crawford (2014) Activity groups for people with schizophrenia: a randomized controlled trial, Journal of Mental Health, 23:4, 171-175 To link to this article: http://dx.doi.org/10.3109/09638237.2014.889285
Published online: 24 Mar 2014.
Submit your article to this journal
Article views: 244
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijmh20 Download by: [Universite Laval]
Date: 05 November 2015, At: 18:13
http://informahealthcare.com/jmh ISSN: 0963-8237 (print), 1360-0567 (electronic) J Ment Health, 2014; 23(4): 171–175 ! 2014 Informa UK Ltd. DOI: 10.3109/09638237.2014.889285
ORIGINAL ARTICLE
Activity groups for people with schizophrenia: a randomized controlled trial Madeleine Dean1, Adam R. W. Weston1, David P. Osborn2, Suzie Willis3, Sue Patterson1, Helen Killaspy2, Baptiste Leurent4, and Mike J. Crawford1 1
Centre for Mental Health, Imperial College London, London, UK, 2Mental Health Sciences Unit, University College London, London, UK, Central and North West London NHS Foundation Trust, London, UK, and 4Department of Primary Care and Population Health, University College London, London, UK
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3
Abstract
Keywords
Background: UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. Aims: To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. Methods: Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). Results: About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score ¼ 6.0, 95% CI 2.3 to 9.8) but global functioning did not (change in GAF score ¼ 0.8, 95% CI 1.7 to 3.3). No significant differences were found between treatment arms. Conclusions: Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.
Activity group, schizophrenia, randomized controlled trial
Introduction Schizophrenia is a severe mental illness which affects up to 1.4% of people during their lifetime (Cannon & Jones, 1996). Negative symptoms of schizophrenia impair social functioning, are associated with reduced quality of life (Pfammatter et al., 2006) and increased likelihood of relapse and hospital admission (Couture et al., 2006). Pharmacological treatments have limited efficacy in treating negative schizophrenia symptoms (Conley & Buchanan, 1997). There is evidence that some psychosocial interventions are effective in conjunction with medication (Pfammatter et al., 2006). Social activity groups comprise a form of psychosocial intervention that is widely available in mental health services in the UK (Rogers & Pilgrim, 1993) but there is limited evidence available about their efficacy. A systematic review of the effectiveness of activity groups for people with mental disorders (Bullock & Bannigan, 2011) identified two trials which examined the effects of activity groups (DeCarlo &
History Received 28 August 2013 Revised 10 November 2013 Accepted 11 January 2014 Published online 24 February 2014
Mann, 1985; Schindler, 1999). Neither study examined the effects of activity groups for people with psychosis or measured the effect on mental health or general functioning. Nevertheless, the National Institute for Health and Clinical Excellence recommends that people with a diagnosis of schizophrenia have access to social activities throughout their care (National Collaborating Centre for Mental Health, 2010). The MATISSE study (Multicentre trial of Art Therapy In Schizophrenia: Systematic Evaluation) was a three-arm randomized controlled trial that investigated the efficacy of group art therapy plus standard care, activity groups plus standard care and standard care alone for people with a diagnosis of schizophrenia (Crawford et al., 2012). We undertook a secondary analysis of data from this trial. The aim was to investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone.
Method Correspondence: M. J. Crawford, Professor in Mental Health Research, Centre for Mental Health, Imperial College London, Claybrook Centre, 37, Claybrook Road, London W6 8LN, UK. Tel: +207 386 1233. Fax: +207 386 1216. E-mail: [email protected]
Participants and setting This analysis of the MATISSE project (ISRCTN: 46150447) included data from participants randomized to receive weekly
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activity groups or standard care alone. Participants were recruited from three centers in England and one in Northern Ireland. Centers were selected because they had systems for delivering group art therapy and for supervising arts therapists. The centers include a mix of inner city, urban, semi-rural and rural areas and serve a population of people from many different ethnic backgrounds. Participants were recruited from secondary care settings including day hospitals, community mental health teams, rehabilitation services, supported accommodation and day centers. Eligibility criteria were aged 18 years or older, living in the community and a clinical diagnosis of schizophrenia confirmed by OPCRIT (McGuffin et al., 1991). Exclusion criteria comprised severe cognitive impairment, inability to complete the assessments due to language difficulties and currently receiving any arts therapies. All participants provided written informed consent. The study was approved by Huntingdon Research Ethics Committee (06/Q0104/82) prior to data collection. Further details about the trial methods are reported elsewhere (Crawford et al., 2010). Measures Outcomes were assessed through an interview with the researchers at recruitment and 12 months later using standardized measures. The primary outcomes were mental health, assessed using the Positive And Negative Symptom Scale (PANSS) (Kay et al., 1987), and global functioning, assessed using the Global Assessment of Functioning (GAF) (Jones et al., 1995). Secondary outcomes were positive, negative and general symptoms sub-scales of the PANSS, social function assessed using the Social Function Schedule (Tyrer et al., 2005), wellbeing assessed using the General Well-Being Scale (Norman et al., 2000), and medication adherence assessed using the Morisky scale (George et al., 2000). Interventions The structure and content of the activity groups were based on those of groups commonly provided by mental health and social care services for people with psychosis in the UK. Groups had a maximum of eight members at one time and were run for up to 90 min, on a weekly basis over 12 months. Groups were run by two facilitators, at least one of whom had previous experience working with this patient group. The lead facilitator of each group received training prior to the start of the study and monthly supervision from a senior practitioner. Facilitators offered participants a range of activities including discussions, board games and visits to places of interest. Participants were encouraged to select activities and were allowed to spend up to £10 ($15) per session in expenses. Facilitators were asked not to offer creative activities, skills training, occupational therapy or psychotherapy. If participants expressed concerns about their mental health, facilitators were advised to encourage participants to seek help and advice from other mental health professionals involved in their care and not to explore thoughts and feelings to avoid delivering psychotherapeutic interventions.
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To assess treatment fidelity, facilitators completed a proforma at the end of a session to record group details including: the chosen activity, duration of attendance, management of any breaches of group boundaries and the response group facilitators made to any issues raised by attendees. These proforma were subsequently examined to check the content of groups and evidence of boundary breeches. Standard care comprised of usual contact and treatment from secondary mental health care services, including outpatient appointments, access to day care and inpatient treatment, treatment with medication and psychosocial interventions other than arts therapies. Procedures At each center researchers publicized the study through meetings with clinical staff. Potential participants who gave verbal consent to be contacted to clinical staff, met with a researcher who provided information, assessed eligibility and obtained written informed consent. Baseline assessments were conducted before randomization, which was undertaken by an independent remote telephone service provided by the Aberdeen Clinical Trials Unit. Permuted stacked blocks of three to six were used, stratified by site. An independent administrator advised participants, their mental health worker, general practitioner and if relevant the activity group facilitator, of their study arm allocation status. Group facilitators made concentrated efforts to engage with participants to encourage their attendance and retention in groups including contact by letter and phone, arranging a time to discuss the group and offering to meet up before a group to give details about it, answer any questions and discuss any concerns. Groups were held during normal working hours in clinics, day centers and other premises within the catchment area where participants lived. Researchers who carried out follow up interviews remained masked to allocation status. Participants were offered £15 ($22) honorarium for their time completing assessments. Data analysis All primary analyses were conducted using the intentionto-treat principle in SPSS Version 18.0. Analyses were performed on participants with complete data. Within group differences between baseline and 12 months and differences between treatment arms at 12 months were examined using appropriate t-tests. Differences in primary outcomes between those randomized to activity groups or standard care alone were then examined using linear regression adjusted for baseline value, gender and age. In subsequent analysis, we used two-stage least squares estimation of average causal effects in models with variable treatment intensity (Angrist & Imbens, 1995). This analysis estimates the effect of attending the activity groups for a person willing to attend. It assumes that the effect of allocation to treatment has no effect on the outcome if the patient does not receive the treatment. We estimated the benefit per session, assuming benefit to be proportional to the number of sessions attended, and adjusted for site, gender and age.
Activity groups for people with schizophrenia
DOI: 10.3109/09638237.2014.889285
Results
Primary and secondary outcomes
About 649 people were assessed between February 2007 to August 2008, of whom 584 (90%) were eligible (see Figure 1). Of these, 167 (28.7%) declined to take part, 140 were randomized to receive art therapy, 140 to receive activity groups and 137 to standard care alone. Characteristics of those randomized to activity groups or standard care alone are presented in Table 1. About 242 (87.4%) of these participants completed the 12-month assessment. Baseline characteristics of participants who did not complete the follow-up did not differ from those who did.
The unadjusted study outcomes at baseline and 12 months are presented in Table 2. Participants allocated to receive activity groups showed statistically significant improvements in all mental health symptom scores, wellbeing and medication
Uptake of and content of activity groups
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Of the 140 participants allocated to receive activity groups, 73 (52%) attended at least one session. The median time between randomization and attendance at the first group was 61.5 days. This delay was due to groups not being able to start until sufficient numbers of participants had been recruited to commence a group. Among those who attended the activity groups, the mean number of groups attended was 2.1 (SD ¼ 0.9). Group size varied from one to nine, with fluctuating attendance over the 12-month period. Examination of 443 activity groups proformas identified the following activities had been undertaken: 203 (45.8%) sessions involved excursions, 137 (30.9%) entailed playing games/sports, 76 (17.2%) were spent watching DVDS, 52 (11.7%) involved themed discussions, 21 (4.7%) were spent cooking, 21 (4.7%) entailed completing puzzles/ quizzes and two (0.5%) involved storytelling. There was no evidence that use of art materials or engagement in craft activities occurred and group boundaries were adhered to.
Table 1. Participant characteristics at baseline. Standard care n ¼ 137
Variable Center West London North London Avon and Wilshire Belfast Gender Male Female Mean age Ethnicity White British White Other Black Other Marital status Married/living as Divorced/separated/widowed Single Education Degree A-levels GCSE NVQ/vocational training None Median age at onset of psychosis (IQR)
Figure 1. Consort diagram.
44 38 33 22
Activity group n ¼ 140
(32%) (28%) (24%) (16%)
43 38 35 24
(31%) (27%) (25%) (17%)
Total n ¼ 277 87 76 68 46
(31%) (27%) (25%) (17%)
99 (72%) 90 (64%) 189 (68%) 38 (28%) 50 (36%) 88 (32%) 40 (SD 12) 42 (SD 12) 41 (SD 12) 76 25 27 9
(55%) (18%) (20%) (7%)
71 28 26 15
8 (6%) 12 (9%) 117 (85%) 18 14 40 22 35 20
(51%) (20%) (19%) (11%)
12 (9%) 22 (16%) 106 (76%)
(14%) (11%) (31%) (17%) (27%) (18–26)
15 21 43 13 46 22
(11%) (15%) (31%) (9%) (33%) (18–29)
147 53 53 24
(53%) (19%) (19%) (1%)
20 (7%) 34 (12%) 223 (81%) 33 35 83 35 81 21
(12%) (13%) (31%) (13%) (30%) (18–28)
Assessed for eligibility n=649
Excluded n=232 Not Eligible n= 65 Refused n=167
Randomised n=417 (Allocated to art therapy n = 140)
Allocated to standardcare n=137
Dropped out n=10 Died n=1 Lost to follow up n=5 Withdrawn n=4
12 months assessment n=121
Allocated to activity group n=140
Dropped out n=11 Died n=2 Lost to follow up n=7 Withdrawn n=2
12 months assessment n=121
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Table 2. Unadjusted outcomes at baseline and 12-month assessment. Standard care
Outcomes
Baseline 12 months mean (SD) mean (SD)
PANSS total PANSS general PANSS positive PANSS negative Global functioning General wellbeing Social function schedule Medication adherence
71.8 36.8 17.2 18.4 44.6 64.5 8.1 1.2
(21.2) (11.3) (5.7) (7.5) (12.9) (20.4) (4.7) (1.3)
71.2 36.3 16.7 18.2 45.7 64.9 8.4 0.7
(24.6) (13.0) (6.3) (7.7) (14.4) (23.3) (4.9) (1.1)
Activity group Change (95% CI)
0.6 0.5 0.5 0.3 1.2 0.4 0.3 0.5
(4.2 (2.4 (1.6 (1.6 (1.2 (2.9 (0.6 (0.7
to to to to to to to to
3.0) 1.4) 0.6) 1.0) 3.5) 3.7) 1.2) 0.2)***
Baseline 12 months mean (SD) mean (SD) 75.8 38.4 18.4 18.6 44.7 59.1 8.8 1.1
(22.2) (12.0) (6.7) (6.8) (12.7) (19.2) (4.8) (1.2)
69.8 35.7 16.2 17.2 45.5 63.9 8.2 0.6
(23.0) (12.7) (5.9) (7.2) (14.1) (23.6) (4.7) (0.9)
Change (95% CI) 6.0 2.7 2.2 1.4 0.8 4.9 0.5 0.4
(9.8 to 2.3)** (4.7 to 0.6)* (3.3 to 1.1)*** (2.5 to 0.2)* (1.7 to 3.3) (0.8 to 9.0)* (1.5 to 0.4) (0.7 to 0.2)***
Mean difference between arms (95% CI) 1.9 (8.2 to 4.4) 0.5 (3.8 to 2.8) 0.6 (2.2 to 0.9) 0.9 (2.9 to 1.0) 0.2 (3.8 to 3.4) 0.8 (7.0 to 5.3) 0.4 (1.7 to 0.9) 0.02 (0.3 to 0.2)
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*p50.05, **p 0.01, ***p 0.001.
adherence between recruitment and 12-month assessment. Participants who received standard care alone showed improvement in medication adherence only. However, there were no significant differences in GAF score at 12 months between study arms (Difference ¼ 0.2, p ¼ 0.9), total PANSS score (Difference ¼ 1.9, p ¼ 0.6) or any of the secondary outcomes. When adjusted for baseline score, age and gender neither the total PANSS score (beta ¼ 0.1, p ¼ 0.07) or the GAF score (beta ¼ 0.01, p ¼ 0.9) were significant. The estimated average causal effect of attendance at activity groups in relation to total PANSS score was 0.5 (95% CI 1.2 to 0.2) at 12 months. That is, for every session a participant attended we found an average decrease of 0.5 in the PANSS Score that was not statistically significant. For global functioning, the estimated average causal effect of attendance at an activity groups was 0.08 (95% CI 0.5 to 0.4).
Discussion This secondary analysis reports on the efficacy of activity groups for patients with schizophrenia. Although there were improvements in mental health and wellbeing among those randomized to activity groups, between group comparisons failed to find a statistically significant difference. However, uptake and attendance at groups was poor. While improvements in mental health were found among those randomized to activity groups, it is possible that these differences arose due to unknown confounders, not the randomized groups. This study is the first to examine the effects of social activity groups on mental health or social functioning of people with schizophrenia in a large-scale randomized trial. Two previous trials examined the impact of activity groups on interpersonal skills (DeCarlo & Mann, 1985; Schindler, 1999). However, neither study examined mental health and social functioning. Other research has compared the effectiveness of activity groups with cognitive behavioral therapy, but the absence of an ‘‘inactive’’ control means that the impact of attending the activity groups could not be tested (Haddock et al., 2009). Previous trials of psychosocial interventions for people with schizophrenia have been shown to be effective in improving symptoms and functioning (Pfammatter et al.,
2006; Razali et al., 2000; Xia et al., 2011). Such interventions focus more directly on the symptoms of schizophrenia than activity groups. However, there is evidence that promoting activity may lead to improvements in social function through encouraging motivation and daytime structure (Cook & Howe, 2003). Levels of engagement in the activity group suggest that simply offering a place in an activity group is inadequate and service users are likely to require more proactive support to improve engagement. Strengths and limitations The major strengths of this study were the broad inclusion and narrow exclusion criteria, the masking of researchers to treatment allocation and the high follow-up rate. Groups were run by experienced staff who received regular supervision. Data from a parallel qualitative study supports findings from the review of study proforma that groups were delivered as they were intended and adhered to group boundaries (Patterson, 2010). However, this study has a number of limitations which need to be considered when interpreting the findings. Firstly, the findings presented in this paper are based on a secondary analysis of data from a larger study originally designed to test the efficacy of group art therapy for people with schizophrenia. The sample size for the original study was based on a primary hypothesis of the differences in global functioning between those randomized to group art therapy and standard care alone. However, with a total of 277 participants for the activity groups and standard care alone, we had sufficient power to detect clinically important differences in outcomes between those randomized to activity groups and standard care alone. A key finding was that attendance at activity groups was low. Reasons for non-attendance and drop out were explored in the integrated process evaluation (Patterson et al., 2012). There were several reasons participants stated including moving areas prior to the group starting, perceived wellness and practical issues such as transport. Additionally, unlike in previous trials of complex interventions when patients who received their preferred treatment were around half as likely to drop-out of treatment (Swift & Callahan, 2009) participants were more likely to attend if they received an intervention they desired but most of them were
DOI: 10.3109/09638237.2014.889285
not treatment seeking at all (Patterson, 2010). This suggests that low levels of attendance cannot be explained by participants having a strong preference for the other active intervention. Levels of attendance at group art therapy in the trial were also low (Crawford et al., 2012) suggesting that patient motivation and organizational skills which are known to be poor in people with schizophrenia (Johnstone et al., 2009; Killaspy et al., 2000) may have partially led to the low level of attendance at groups. There was a statistically significant reduction in schizophrenia symptoms scores within the activity group arm. This does not provide evidence that the activity group treatment was more effective than standard care alone (Bland & Altman, 2011). This finding indicates that further research in this area is needed to help understand if and how participation in activity groups may lead to changes in mental health and social functioning.
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Implications for future research The findings of this study highlight the weakness of the evidence base for the effectiveness of activity groups for people with psychosis. The low level of attendance at the groups suggests that further effort needs to be made to evaluate factors that influence attending activity groups and to develop new approaches to engage people with psychosis in social activities. Further qualitative research may help to understand service user experiences of using social groups and help design new approaches to engage people. We did not find evidence that activity group treatment has a positive effect on mental health symptoms, global functioning or any of our secondary outcomes. However, within group differences among those allocated to activity groups supports future research in this area. Further research needs to be undertaken to understand about how to engage people with psychosis in social activities and clinical trials examining the outcomes of these interventions if, recommendations that these interventions for people with a diagnosis of schizophrenia are to be sustained.
Acknowledgements The MATISSE study was supported by the NIHR Technology Assessment Programme. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR or the Department of Health. All authors critically reviewed this paper.
Declaration of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
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