A single-blind randomised controlled trial to determine the effectiveness of group Cognitive Behaviour Therapy (CBT) in the prevention of depression in high risk adolescents
| ISRCTN | ISRCTN19083628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19083628 |
| Secondary identifying numbers | HTA 06/37/04 |
- Submission date
- 28/09/2007
- Registration date
- 01/10/2007
- Last edited
- 08/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
We aim of this study is to test whether a school-based depression prevention programme developed in Australia, the Resourceful Adolescent Programme (RAP), is effective at reducing depressive symptoms in high-risk children in the UK.
Who can participate?
Children aged 13-16 from 9-12 mixed comprehensive schools in Bath, Bristol, Nottingham and Swindon
What does the study involve?
Participants complete a questionnaire. Their scores are used to categorise them as either low or high risk of depression or probably depressed. We want to find out what happens to the high risk group (about 20% of each class). Whole classes of children are randomly assigned to receive either the RAP, a placebo (dummy) intervention, or treatment as usual (Personal Health and Social Education - PHSE). For RAP and the placebo intervention each student has a workbook and sessions are led by trained and supervised mental health professionals. We assess children's mood, negative thoughts and self-image before we start and again at 6 and 12 months. This allows us to see whether RAP is effective and if these gains last. We also want to find out whether RAP is good value and so we work out how much it costs and what it saves.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal United Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2008 to December 2011
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Prof. Paul Stallard
paul.stallard@awp.nhs.uk
Contact information
Scientific
Department of Child and Family Psychiatry
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
| Phone | +44 (0)1225 383860 |
|---|---|
| paul.stallard@awp.nhs.uk |
Study information
| Study design | Cluster randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A single-blind randomised controlled trial to determine the effectiveness of group Cognitive Behaviour Therapy (CBT) in the prevention of depression in high risk adolescents |
| Study hypothesis | Group based CBT delivered in schools is effective and cost effective in preventing depression in adolescents at high risk of depression. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/063704 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/51378/PRO-06-37-04.pdf |
| Ethics approval(s) | University of Bath Ethical Committee: School for Health: School Research Ethics Approval Panel (SREAP), 18/12/2007 |
| Condition | Depression |
| Intervention | Interventions will be provided during the usual Personal, Social and Health Education (PSHE) sessions (1 hour per session, total of 11 sessions over one school term). Arm A: Group CBT. CBT recognises the importance of negative thoughts and low self-worth/image in the onset and maintenance of depression. These are therefore actively targeted during CBT with core treatment components including psycho education, identifying and challenging negative/dysfunctional thoughts, identifying personal strengths (thereby enhancing self-esteem/image), managing social problems, and learning to problem solve. Arm B: Attention placebo. The attention placebo intervention will involve similar time and contact with an external group leader but will not include the active components of the CBT intervention. The content will be based upon the PSHE provided in schools but will be provided by leaders from outside of the school. This will therefore control for the non-specific effects of interventions that are considered important in studies of depression. Arm C: Usual PSHE |
| Intervention type | Other |
| Primary outcome measure | Changes in depression symptoms as assessed by the short form Mood and Feelings Questionnaire at 12 months follow-up. |
| Secondary outcome measures | 1. Changes in self-image and negative thoughts. These will be assessed at 12 months by the following questionnaires: 1.1. Self Image Profiles (SIP-A). An easily competed 25-item scale for adolescents assesses how they perceive themselves and how they would like to be. Twelve items assess positive attributes (e.g. confident, fun to be with), twelve assess negative attributes (e.g. annoying, moody) and one is neutral (i.e. feel different from others). 1.2. Children's Automatic Thoughts Scale (CATS). This self-completed scale assesses a range of negative self statements in children and young people aged 7-16. For each item the child is asked to rate whether they have had a similar thought over the past week. Each item is rated as "not at all" (scores 0), "sometimes" (scores 1), "fairly often" (scores 2), "often" (scores 3) or "all the time" (scores 4). The 10-item personal failure sub-scale will be used. 2. Cost effectiveness at 12 months |
| Overall study start date | 01/09/2008 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 5,000 children of whom 1,000 will be at "high risk" of depression. |
| Total final enrolment | 5030 |
| Participant inclusion criteria | All children aged 13-16 attending participating schools (n = 8-12) |
| Participant exclusion criteria | No exclusion criteria |
| Recruitment start date | 01/09/2008 |
| Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BA1 3NG
United Kingdom
Sponsor information
University/education
School for Health
Bath
BA2 7AY
England
United Kingdom
| Website | http://www.bath.ac.uk/health/ |
|---|---|
"ROR" |
https://ror.org/002h8g185 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/11/2010 | Yes | No | |
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | cost-effectiveness results | 01/12/2014 | Yes | No | |
| Results article | results | 05/10/2012 | 08/05/2019 | Yes | No |
Editorial Notes
08/05/2019: Total final enrolment and publication reference were added.
26/05/2016: Plain English summary added.
29/04/2008: due to a delay in ethics approval, the overall trial start and end dates were updated again. The previous dates were:
Overall trial start date: 01/01/2008.
Overall trial end date: 30/04/2012.
11/01/2008: the overall trial end date was changed from 30/04/2012 to 30/04/2011.
