| Source of record | UK Trials |
| ISRCTN | ISRCTN19083628 |
| Date ISRCTN assigned | 01/10/2007 |
| Local reference number(s) | HTA 06/37/04 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Depression |
| Study hypothesis | Group based CBT delivered in schools is effective and cost effective in preventing depression in adolescents at high risk of depression. |
| Design/methodology | Cluster randomised controlled trial. |
| Research ethics review | This trial was submitted to the South West Research Ethics Committee in Dartington, UK (ref: 07/HO206/67). Decision pending. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All children aged 13-16 attending participating schools (n = 8-12). |
| Participants - exclusion criteria | None |
| Patient information material |
|
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 30/04/2012 |
| Status of trial | Ongoing |
| Target number of participants | 5,000 children of whom 1,000 will be at "high risk" of depression. |
| Interventions | Please note that, as of 11 January 2008, the anticipated end date of this trial has been updated from 30 April 2012 to 30 April 2011.
Interventions:
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 |
| Primary outcome measure(s) | Changes in depression symptoms as assessed by the short form Mood and Feelings Questionnaire at 12 months follow-up. |
| Secondary outcome measure(s) | 1. Changes in self-image and negative thoughts. These will be assessed at 12 months by the following questionnaires:
a. 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).
b. 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. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Bath, School for Health (UK) |
| Sponsor details | Bath
-
United Kingdom
BA2 7AY |
| Sponsor website | http://www.bath.ac.uk/health/ |
| Contact name | Prof Paul Stallard |
| Contact details | Department of Child and Family Psychiatry
Royal United Hospital
Combe Park
Bath
United Kingdom
BA1 3NG |
| Contact telephone | +44 (0)1225 383860 |
| Contact fax | +44 (0)1225 825076 |
| Contact email | paul.stallard@awp.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN19083628 |
| Date last extracted from ISRCTN register | 17/04/2008 |
