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Open Access Highly Accessed Study protocol

The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial

Helen Waller1*, Tom Craig2, Sabine Landau3, Miriam Fornells-Ambrojo45, Nedah Hassanali4, Catherine Iredale4, Suzanne Jolley1, Paul McCrone2 and Philippa Garety1

Author Affiliations

1 Department of Psychology, Institute of Psychiatry, King’s College London, London, UK

2 Department of Health Service and Population Research, Institute of Psychiatry, King’s College London, London, UK

3 Department of Biostatistics, Institute of Psychiatry, King’s College London, London, UK

4 South London and Maudsley NHS Foundation Trust, London, UK

5 University College London, London, UK

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Trials 2014, 15:255  doi:10.1186/1745-6215-15-255

Published: 27 June 2014

Abstract

Background

NICE guidance states that cognitive behavioural therapy (CBT) should be offered to all patients with psychosis. However, there is a need to improve access to therapeutic interventions. We aim to train frontline mental health staff to deliver brief, structured CBT-based therapies. We have developed and piloted a manualized intervention to support people with psychosis and anxious avoidance or depression to work towards a personal recovery goal.

Methods/Design

The ‘GOALS Study’ is a pilot randomized controlled trial comparing usual care plus an 8-week intervention with usual care alone. The key objective is to assess clinical feasibility (recruitment and randomization; compliance with the treatment manual; acceptability and satisfaction; progress towards goals). A secondary objective is a preliminary evaluation of efficacy. Sixty-six participants with a diagnosis of psychosis, plus symptoms of depression or anxiety will be recruited from adult mental health services. Those currently refusing medication, in receipt of CBT, or with a primary diagnosis of an organic mental health problem or substance dependency will be excluded. Following informed consent, randomization will be independent of the trial team, at a 50:50 ratio, at the level of the individual and stratified by main problem focus. Following randomization, participants allocated to the intervention group will begin the 8-week intervention with a local, trained member of staff, supervised by the study coordinator. Outcomes will be assessed blind to treatment condition at 0, 12 and 18 weeks post-randomization. The primary outcome measure for the efficacy analysis will be activity levels at 12 weeks. Secondary outcome measures include mood, psychotic symptoms, quality of life and clinical distress. A health economic analysis comparing service use in each condition will also be performed. Recruitment began in March, 2013 and is ongoing until December, 2014.

Discussion

This is the first trial of the GOALS intervention. The approach is brief and staff can be readily trained in its delivery: there is therefore potential to develop a cost-effective intervention that could be widely disseminated. If the trial proves clinically feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted.

Trial registration

Current Controlled Trials ISRCTN: 73188383. http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13538 webcite

Keywords:
Anxiety; Behavioural activation; CBT; Depression; Graded exposure; Psychosis