Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and comorbid substance misuse: randomised controlled trialBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c6325 (Published 24 November 2010) Cite this as: BMJ 2010;341:c6325
- Christine Barrowclough, professor of clinical psychology1,
- Gillian Haddock, professor of clinical psychology1,
- Til Wykes, professor of clinical psychology and rehabilitation2,
- Ruth Beardmore, trial manager1,
- Patricia Conrod, senior lecturer2,
- Tom Craig, professor of community and social psychiatry2,
- Linda Davies, professor of health economics3,
- Graham Dunn, professor of biomedical statistics3,
- Emily Eisner, research associate1,
- Shôn Lewis, professor of adult psychiatry3,
- Jan Moring, consultant clinical psychologist4,
- Craig Steel, senior lecturer5,
- Nicholas Tarrier, professor of clinical psychology1
- 1School of Psychological Sciences, University of Manchester, Manchester, UK
- 2King’s College London, London, UK
- 3School of Community Based Medicine, University of Manchester, Manchester
- 4Substance Misuse Directorate, Greater Manchester West Mental Health NHS Foundation Trust, Prestwich, UK
- 5School of Psychology and Clinical Language Sciences, University of Reading, Whiteknights, Reading, UK
- Correspondence to: C Barrowclough
- Accepted 16 September 2010
Objectives To evaluate the effectiveness of integrated motivational interviewing and cognitive behavioural therapy in addition to standard care for patients with psychosis and a comorbid substance use problem.
Design Two centre, open, rater blind randomised controlled trial.
Setting Secondary care in the United Kingdom.
Participants 327 patients with a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a diagnosis of dependence on or misuse of drugs, alcohol, or both according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition.
Intervention The intervention was integrated motivational interviewing and cognitive behavioural therapy plus standard care, which was compared with standard care alone. Phase one of therapy—“motivation building”—concerns engaging the patient, then exploring and resolving ambivalence for change in substance use. Phase two—“action”—supports and facilitates change using cognitive behavioural approaches. Up to 26 therapy sessions were delivered over one year.
Main outcome measures The primary outcome was death from any cause or admission to hospital in the 12 months after completion of therapy. Secondary outcomes were frequency and amount of substance use (assessed using the timeline followback method), readiness to change, perceived negative consequences of use, psychotic symptom ratings, number and duration of relapses, and global assessment of functioning and deliberate self harm at 12 and 24 months, with additional timeline followback assessments at 6 and 18 months. Analysis was by intention to treat and robust treatment effect estimates were produced.
Results 327 participants were randomly allocated to either the intervention (n=164) or treatment as usual (n=163). At 24 months, 326 (99.7%) were assessed on the primary outcome and 246 (75.2%) on the main secondary outcomes. Treatment had no beneficial effect on hospital admissions or death during follow-up, with 23.3% (38/163) of the therapy group and 20.2% (33/163) of controls deceased or admitted (adjusted odds ratio 1.16, 95% confidence interval 0.68 to 1.99; P=0.579). Therapy had no effect on the frequency of substance use or the perceived negative consequences of misuse, but did have a statistically significant effect on amount used per substance using day (adjusted ORs for main substance 1.50, 95% CI 1.08 to 2.09; P=0.016; and all substances 1.48, 95% CI 1.07 to 2.05; P=0.017). Treatment had a statistically significant effect on readiness to change use at 12 months (adjusted OR 2.05, 95% CI 1.26 to 3.31; P=0.004) that was not maintained at 24 months (0.78, 95% CI 0.48 to 1.28; P=0.320). There were no effects of treatment on clinical outcomes such as relapses, psychotic symptoms, functioning, and self harm.
Conclusions Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and substance misuse do not improve outcome in terms of hospitalisation, symptom outcomes, or functioning. This approach does reduce the amount of substance used for at least one year after completion of therapy.
Trial registration Current Controlled Trials: ISRCTN14404480.
We thank the patients who participated in the study and all the staff who facilitated recruitment. We are also grateful to all the collaborating NHS trusts and to all the research assistants. TW acknowledges some additional funding provided by National Institute for Health Research (NIHR) Biomedical Research Centre for Mental Health at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Kings College London. All authors acknowledge the support of the NIHR Mental Health Research Network.
Contributors: All authors were involved in the design of the study and the ongoing management of the trial, and contributed to drafts of this report. CB, the principal investigator, conceived of the study, prepared the protocol, contributed to the training and supervision of the therapists and supervision of the researchers, had overall responsibility for the day to day running of the study, interpreted the data, and took the lead on writing this report. She is the guarantor for the study. GH, NT, TW, CS, JM, and PC participated in preparation of the treatment protocol and the training and supervision of the therapists. JM and PC were also responsible for training and supervising staff in administration of substance use measures. TW managed the London site. GH, SL, and TC trained the researchers in the psychiatric interviews, supervised and monitored standards of psychiatric interviewing and assessment throughout the trial. SL and TC also advised on diagnostic ratings and exclusions. RB was the trial manager. She supervised and coordinated recruitment, contributed to training of research staff, and was responsible for staff management and overall coordination of the study. EE replaced RB for the latter part of the study. GD was the trial statistician. He advised on randomisation and all statistical aspects of the trial, developed the analysis plan, and performed the statistical analyses. LD was the trial health economist.
Funding: The study was sponsored by the University of Manchester and funded by the UK Medical Research Council (grant no: GO200471) and the Department of Health. The sponsor and the funder of the study had no role in the study design, the data collection, analysis, and interpretation, or the reporting of this work, or the decision to submit the work for publication. All authors are independent of the funding source. All authors had full access to all study data.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Ethical approval was obtained from the Cambridgeshire 4 research ethics committee (formerly the eastern multicentre research ethics committee; reference 03/5/045). All participants gave written informed consent before taking part.
Data sharing: We will be happy to make our dataset available to researchers once we have finished reporting our findings. Please contact the corresponding author at.
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