Service user perspectives of community mental health services for people with complex emotional needs: a co-produced qualitative interview study.

BACKGROUND: There is consensus that services supporting people with complex emotional needs are part of a mental health care system in which change is needed. To date, service users' views and co-production initiatives have had little impact on the development of interventions and care. This needs to change, and our paper evidences the experiences and perspectives of a diverse range of people on how community services can best address the needs of people with complex emotional needs. METHODS: A co-produced qualitative research study. Lived experience researchers led data collection and analysis. Individual interviews were conducted with 30 people across England who had a diverse range of experiences and perspectives of using community services for complex emotional needs. Participants were asked about their experiences of using community services for their mental health, and views on how community services can best address their needs. Thematic analysis was used to analyse the data. RESULTS: Participants reported some experiences of good practice but also of experiences of severely stigmatising interventions, a lack of effective support and service fragmentation. Relational Practice was identified as the central overarching theme and describes how community services can best support people with complex emotional needs. This approach involves care delivered in a non-stigmatising, individualised and compassionate way and care that is trauma-informed. It involves care that is planned collaboratively with service users to ensure their multiple needs are addressed in a flexible, holistic and consistent way which accounts for the long-term and fluctuating nature of their needs. CONCLUSIONS: Relational practice approaches have potential to facilitate better community care for people with complex emotional needs. Research and service development are needed to examine how best to implement such approaches across the mental health service system. This work must be co-produced with people with relevant lived experience, their carers and the professionals who support them.

Patient experiences of therapy for borderline personality disorder: Commonalities and differences between dialectical behaviour therapy and mentalization-based therapy and relation to outcomes.

OBJECTIVES: Dialectical behaviour therapy (DBT) and mentalization-based therapy (MBT) are widely used evidence-based psychological treatments for borderline personality disorder (BPD). The study aimed to establish evidence on common and unique, and helpful and unhelpful, treatment processes. DESIGN: Mixed-methods. METHODS: In-depth qualitative interview data on patient experiences during treatment were combined with quantitative outcome measures in 73 patients diagnosed with a personality disorder and receiving DBT or MBT. RESULTS: Across both DBT and MBT, accounts of learning not to react impulsively, learning to question one's thoughts and assumptions, learning to communicate more effectively, and exposure to painful emotions that may previously have been avoided were each associated with less baseline-adjusted self-harm at the end of treatment. Difficulties in interacting with other group members were more likely to be described by patients receiving MBT than DBT, whilst difficulties in the therapeutic relationship were equally common. Both of these types of difficult experience were associated with higher baseline-adjusted levels of BPD traits and emotional dysregulation, at the end of the 12-month study period. CONCLUSIONS: The findings identify novel evidence of common therapeutic processes across DBT and MBT that may help to reduce self-harm. The findings also highlight the potential iatrogenic effect of difficulties in the alliance with therapists or with other group members. This underscores the importance of listening to patients' voices about what they are finding difficult during therapy and working to address these relational challenges, so that the patient is able to progress and make best use of the treatment. PRACTITIONER POINTS: Regardless of whether dialectical behaviour therapy or mentalization based therapy is used, helping service-users to learn not to react impulsively, to question their thoughts and assumptions, and to communicate more effectively, may be beneficial for reducing self-harm. Across both types of therapy, exposure to painful emotions is a difficult experience for service-users, but may also be beneficial for reducing self-harm, if carefully managed. Whilst service-users' experiences across both types of therapy have much in common, accounts of mentalization based therapy stand out in more often describing both helpful and unhelpful experiences of interactions with therapy group members. Service-users across both types of therapy report the benefits of learning intrapersonal mentalization skills, whilst recipients of mentalization based therapy uniquely extend this to learning interpersonal mentalization. Ruptures in the therapeutic alliance, and distressing interactions with group members, may be iatrogenic and must be carefully managed.

Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation.

BACKGROUND: Antisocial personality disorder (ASPD), although associated with very significant health and social burden, is an under-researched mental disorder for which clinically effective and cost-effective treatment methods are urgently needed. No intervention has been established for prevention or as the treatment of choice for this disorder. Mentalization-based treatment (MBT) is a psychotherapeutic treatment that has shown some promising preliminary results for reducing personality disorder symptomatology by specifically targeting the ability to recognize and understand the mental states of oneself and others, an ability that is compromised in people with ASPD. This paper describes the protocol of a multi-site RCT designed to test the effectiveness and cost-effectiveness of MBT for reducing aggression and alleviating the wider symptoms of ASPD in male offenders subject to probation supervision who fulfil diagnostic criteria for ASPD. METHODS: Three hundred and two participants recruited from a pool of offenders subject to statutory supervision by the National Probation Service at 13 sites across the UK will be randomized on a 1:1 basis to 12 months of probation plus MBT or standard probation as usual, with follow-up to 24 months post-randomization. The primary outcome is frequency of aggressive antisocial behaviour as assessed by the Overt Aggression Scale - Modified. Secondary outcomes include violence, offending rates, alcohol use, drug use, mental health status, quality of life, and total service use costs. Data will be gathered from police and criminal justice databases, NHS record linkage, and interviews and self-report measures administered to participants. Primary analysis will be on an intent-to-treat basis; per-protocol analysis will be undertaken as secondary analysis. The primary outcome will be analysed using hierarchical mixed-effects linear regression. Secondary outcomes will be analysed using mixed-effects linear regression, mixed-effects logistic regression, and mixed-effects Poisson models for secondary outcomes depending on whether the outcome is continuous, binary, or count data. A cost-effectiveness and cost-utility analysis will be undertaken. DISCUSSION: This definitive, national, multi-site trial is of sufficient size to evaluate MBT to inform policymakers, service commissioners, clinicians, and service users about its potential to treat offenders with ASPD and the likely impact on the population at risk. TRIAL REGISTRATION: ISRCTN 32309003 . Registered on 8 April 2016.

Posttraumatic Stress Disorder in Patients With Borderline Personality Disorder: Treatment Outcomes and Mediators.

Posttraumatic stress disorder (PTSD) is highly comorbid with personality disorder (PD). We evaluated whether comorbid PTSD has a negative effect on patients' ability to benefit from evidence-based psychological treatments for PD and tested potential mediators of any effect. The effect of PTSD on self-harm and borderline PD symptoms was evaluated in 90 patients with borderline PD who were receiving dialectical behavior therapy or mentalization-based therapy. Self-report and interview measures were administered every 3 months over a 12-month period. Three-quarters of participants met criteria for PTSD. In the 12 months after beginning treatment, participants with PTSD did not engage in self-harm more often or present with more severe borderline PD symptoms. However, a higher level of PTSD symptom severity at baseline was associated with more frequent self-harm during follow-up, incidence rate ratio = 1.03, 95% CI [1.01, 1.06], p = .005. Participants whose PTSD did not improve or worsened were more likely to still self-harm, odds ratio (OR) = 0.91, 95 % CI [0.85, 0.97], p = .004, and report more severe borderline PD symptoms, b = 0.53, 95% CI [0.34, 0.73], p < .001, at the end of 12 months. The negative effects of PTSD symptoms remained significant after adjusting for potential confounders and were partially mediated by high ongoing levels of emotional dysregulation, indirect effect b = 0.32, 95% CI [0.19, 0.50]. These findings identify subgroups at risk of poorer outcomes from evidence-based psychological treatments for PD and support the idea that treating PTSD may improve outcomes.

Music therapy for depression.

BACKGROUND: Depression is a highly prevalent mood disorder that is characterised by persistent low mood, diminished interest, and loss of pleasure. Music therapy may be helpful in modulating moods and emotions. An update of the 2008 Cochrane review was needed to improve knowledge on effects of music therapy for depression. OBJECTIVES: 1. To assess effects of music therapy for depression in people of any age compared with treatment as usual (TAU) and psychological, pharmacological, and/or other therapies.2. To compare effects of different forms of music therapy for people of any age with a diagnosis of depression. SEARCH METHODS: We searched the following databases: the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR; from inception to 6 May 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; to 17 June 2016); Thomson Reuters/Web of Science (to 21 June 2016); Ebsco/PsycInfo, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and PubMed (to 5 July 2016); the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, the National Guideline Clearing House, and OpenGrey (to 6 September 2016); and the Digital Access to Research Theses (DART)-Europe E-theses Portal, Open Access Theses and Dissertations, and ProQuest Dissertations and Theses Database (to 7 September 2016). We checked reference lists of retrieved articles and relevant systematic reviews and contacted trialists and subject experts for additional information when needed. We updated this search in August 2017 and placed potentially relevant studies in the "Awaiting classification" section; we will incorporate these into the next version of this review as appropriate. SELECTION CRITERIA: All randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing music therapy versus treatment as usual (TAU), psychological therapies, pharmacological therapies, other therapies, or different forms of music therapy for reducing depression. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated standardised mean difference (SMD) for continuous data and odds ratio (OR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. MAIN RESULTS: We included in this review nine studies involving a total of 421 participants, 411 of whom were included in the meta-analysis examining short-term effects of music therapy for depression. Concerning primary outcomes, we found moderate-quality evidence of large effects favouring music therapy and TAU over TAU alone for both clinician-rated depressive symptoms (SMD -0.98, 95% CI -1.69 to -0.27, 3 RCTs, 1 CCT, n = 219) and patient-reported depressive symptoms (SMD -0.85, 95% CI -1.37 to -0.34, 3 RCTs, 1 CCT, n = 142). Music therapy was not associated with more or fewer adverse events than TAU. Regarding secondary outcomes, music therapy plus TAU was superior to TAU alone for anxiety and functioning. Music therapy and TAU was not more effective than TAU alone for improved quality of life (SMD 0.32, 95% CI -0.17 to 0.80, P = 0.20, n = 67, low-quality evidence). We found no significant discrepancies in the numbers of participants who left the study early (OR 0.49, 95% CI 0.14 to 1.70, P = 0.26, 5 RCTs, 1 CCT, n = 293, moderate-quality evidence). Findings of the present meta-analysis indicate that music therapy added to TAU provides short-term beneficial effects for people with depression if compared to TAU alone. Additionally, we are uncertain about the effects of music therapy versus psychological therapies on clinician-rated depression (SMD -0.78, 95% CI -2.36 to 0.81, 1 RCT, n = 11, very low-quality evidence), patient-reported depressive symptoms (SMD -1.28, 95% CI -3.75 to 1.02, 4 RCTs, n = 131, low-quality evidence), quality of life (SMD -1.31, 95% CI - 0.36 to 2.99, 1 RCT, n = 11, very low-quality evidence), and leaving the study early (OR 0.17, 95% CI 0.02 to 1.49, 4 RCTs, n = 157, moderate-quality evidence). We found no eligible evidence addressing adverse events, functioning, and anxiety. We do not know whether one form of music therapy is better than another for clinician-rated depressive symptoms (SMD -0.52, 95% CI -1.87 to 0.83, 1 RCT, n = 9, very low-quality evidence), patient-reported depressive symptoms (SMD -0.01, 95% CI -1.33 to 1.30, 1 RCT, n = 9, very low-quality evidence), quality of life (SMD -0.24, 95% CI -1.57 to 1.08, 1 RCT, n = 9, very low-quality evidence), or leaving the study early (OR 0.27, 95% CI 0.01 to 8.46, 1 RCT, n = 10). We found no eligible evidence addressing adverse events, functioning, or anxiety. AUTHORS' CONCLUSIONS: Findings of the present meta-analysis indicate that music therapy provides short-term beneficial effects for people with depression. Music therapy added to treatment as usual (TAU) seems to improve depressive symptoms compared with TAU alone. Additionally, music therapy plus TAU is not associated with more or fewer adverse events than TAU alone. Music therapy also shows efficacy in decreasing anxiety levels and improving functioning of depressed individuals.Future trials based on adequate design and larger samples of children and adolescents are needed to consolidate our findings. Researchers should consider investigating mechanisms of music therapy for depression. It is important to clearly describe music therapy, TAU, the comparator condition, and the profession of the person who delivers the intervention, for reproducibility and comparison purposes.

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

BACKGROUND: Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). OBJECTIVES: To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. DESIGN: International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. SETTING: Schools and private, voluntary and state-funded health-care services. PARTICIPANTS: Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. INTERVENTIONS: All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. MAIN OUTCOME MEASURES: The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). RESULTS: A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS social affect decreased from 14.1 to 13.3 in music therapy and from 13.5 to 12.4 in standard care [mean difference: music therapy vs. standard care = 0.06, 95% confidence interval (CI) -0.70 to 0.81], with no significant difference in improvement. There were also no differences in the parent-rated social responsiveness score, which decreased from 96.0 to 89.2 in the music therapy group and from 96.1 to 93.3 in the standard care group over this period (mean difference: music therapy vs. standard care = -3.32, 95% CI -7.56 to 0.91). There were seven admissions to hospital that were unrelated to the study interventions in the two IMT arms compared with 10 unrelated admissions in the ESC group. CONCLUSIONS: Adding IMT to the treatment received by children with ASD did not improve social affect or parent-assessed social responsiveness. FUTURE WORK: Other methods for delivering music-focused interventions for children with ASD should be explored. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78923965. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 59. See the NIHR Journals Library website for further project information.

Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial.

Importance: Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication. Objective: To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD. Design, Setting, and Participants: Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016. Interventions: Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention. Main Outcomes and Measures: The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months. Results: Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0.06 [95% CI, -0.70 to 0.81]; P = .88), with no significant difference in improvement. Of 20 exploratory secondary outcomes, 17 showed no significant difference. Conclusions and Relevance: Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months. These findings do not support the use of improvisational music therapy for symptom reduction in children with autism spectrum disorder. Trial Registration: isrctn.org Identifier: ISRCTN78923965.

Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial.

PURPOSE: Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. METHODS: Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia (n = 140) versus standard care alone (n = 137). Positive and Negative Syndrome Scale scores at 12 months were compared between trial arms. Interaction between intervention effect and different subgroups, including those with more severe negative symptoms of schizophrenia, and those who expressed a preference for art therapy prior to randomisation, was tested using a linear mixed model. RESULTS: The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms [interaction for difference in PANSS = 1.7, 95 % CI (-8.6 to 12.1), P = 0.741], or between those who did and did not express a preference for art therapy [interaction = 3.9, 95 % CI (-6.7 to 14.5), P = 0.473]. None of the other exploratory subgroups suggested differences in intervention effect. CONCLUSIONS: There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy. Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive.

Activity groups for people with schizophrenia: a randomized controlled trial.

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 = -6.0, 95% CI -2.3 to -9.8) but global functioning did not (change in GAF score = 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.

Group art therapy as an adjunctive treatment for people with schizophrenia: multicentre pragmatic randomised trial.

OBJECTIVES: To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment. DESIGN: Three arm, rater blinded, pragmatic, randomised controlled trial. SETTING: Secondary care services across 15 sites in the United Kingdom. PARTICIPANTS: 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study. INTERVENTIONS: Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue. MAIN OUTCOME MEASURES: The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months. RESULTS: 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was -0.9 (95% confidence interval -3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (-3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months. CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this trial did not improve global functioning, mental health, or other health related outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46150447.

Music therapy for depression: it seems to work, but how?

Evidence is beginning to emerge that music therapy can improve the mental health of people with depression. We examine possible mechanisms of action of this complex intervention and suggest that music therapy partly is effective because active music-making within the therapeutic frame offers the patient opportunities for new aesthetic, physical and relational experiences.

Provision and practice of art therapy for people with schizophrenia: results of a national survey.

BACKGROUND: Art therapy has been recommended as a treatment for people with psychosis. However, little is known about the availability, organisation or delivery of art therapy within NHS settings. AIMS: To describe the availability, structure and content of art therapy for people with schizophrenia provided by NHS services in England. METHODS: A survey of art therapists working in a randomly selected sample of half of all mental health Trusts in England. RESULTS: Not all mental health Trusts employ art therapists. Those which do employ few therapists, typically on a sessional basis who work across a variety of inpatient and community-based settings. Most art therapists report that their practice is underpinned by psychodynamically grounded understandings of psychosis. However, rather than seek to explore underlying dynamics, art therapists typically adopt a non-directive approach encouraging patients to use image making to express feelings and reflect on these in a concrete way to develop self-understanding. While three-quarters of respondents reported that their work was valued by colleagues, less than half considered art therapy well understood by colleagues or integrated with other services. CONCLUSIONS: People diagnosed with schizophrenia have limited access to art therapy in NHS settings. Further research is needed to understand the experience and outcomes of art therapy to support its meaningful integration within the spectrum of care required to meet the needs of people with schizophrenia.

The MATISSE study: a randomised trial of group art therapy for people with schizophrenia.

BACKGROUND: Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia. METHOD/DESIGN: The MATISSE study is a three-arm, parallel group, pragmatic, randomised, controlled trial of referral to group Art Therapy plus standard care, referral to an attention control 'activity' group plus standard care, or standard care alone. Study participants were recruited from inpatient and community-based mental health and social care services at four centres in England and Northern Ireland. Participants were aged over 18 years with a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria. Participants were then randomised via an independent and remote telephone randomisation service using permuted stacked blocks, stratified by site. Art Therapy and activity groups were made available to participants once a week for up to 12 months. Outcome measures were assessed by researchers masked to allocation status at 12 and 24 months after randomisation. Participants and care givers were aware which arm of the trial participants were allocated to. The primary outcomes for the study are global functioning (measured using the Global Assessment of Functioning scale) and mental health symptoms (measured using the Positive and Negative Syndrome Scale) assessed at 24 months. Secondary outcomes were assessed at 12 and 24 months and comprise levels of group attendance, social function, satisfaction with care, mental wellbeing, and costs. DISCUSSION: We believe that this is the first large scale pragmatic trial of Art Therapy for people with schizophrenia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46150447.

Music therapy for in-patients with schizophrenia: exploratory randomised controlled trial.

BACKGROUND: Music therapy may provide a means of improving mental health among people with schizophrenia, but its effects in acute psychoses have not been explored. AIMS: To examine the feasibility of a randomised trial of music therapy for inpatients with schizophrenia, and explore its effects on mental health. METHOD: Up to 12 weeks of individual music therapy plus standard care were compared with standard care alone. Masked assessments of mental health, global functioning and satisfaction with care were conducted at 3 months. RESULTS: Of 115 eligible patients 81 (70%) were randomised. Two-thirds of those randomised to music therapy attended at least four sessions (median attendance, eight sessions). Multivariate analysis demonstrated a trend towards improved symptom scores among those randomised to music therapy, especially in general symptoms of schizophrenia. CONCLUSIONS: A randomised trial of music therapy for in-patients with schizophrenia is feasible. The effects and cost-effectiveness of music therapy for acute psychosis should be further explored in an explanatory randomised trial.