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Open Access Study protocol

A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial

Carrie-Anne McClay1, Jill Morrison2, Alex McConnachie3 and Christopher Williams1*

Author Affiliations

1 Institute of Health and Wellbeing, University of Glasgow, Gartnavel Royal Hospital, Administration Building, 1055 Great Western Road Glasgow, Glasgow City G12 0XH, UK

2 General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, 1 Horselethill Road, Glasgow G12 9LX, UK

3 Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow G12 8QQ, UK

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Trials 2013, 14:392  doi:10.1186/1745-6215-14-392

Published: 19 November 2013

Abstract

Background

Depression is a mental health condition which affects millions of people each year, with worldwide rates increasing. Cognitive behavioral therapy (CBT) is recommended in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of depression. However, waiting lists can cause delays for face-to-face therapy. Also a proportion of people decline to present for help through the health service – the so-called treatment gap. Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem. The aim of this randomized controlled trial (RCT) is to determine the efficacy of such a guided CBT self-help course, the ‘Living Life to the Full’ (LLTTF) classes delivered by the charity Action on Depression (AOD). The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 (PHQ9) depression scale. Secondary measures include levels of anxiety and social functioning.

Methods/design

Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website. Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course. The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention. Levels of depression, anxiety and social functioning will be assessed and an economic analysis will be carried out.

Discussion

This RCT will test whether the LLTTF intervention is effective and/or cost-effective. If the LLTTF community-based classes are found to be cost effective, they may be helpful as both an intervention for those already seeking care in the health service, as well as those seeking help outside that setting, widening access to psychological therapy.

Trial registration

Current Controlled Trials ISRCTN86292664

Keywords:
Depression; CBT; Guided self-help; Classes; Groups; Psychotherapy; RCT; Voluntary sector; Treatment gap; Economic analysis; Bibliotherapy; Living Life to the Full; LLTTF; Low mood; Distress; Anxiety