Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE).

Paul Stallard,Kapil Sayal,John A Taylor,Rhiannon Buck,Ricardo Araya,Glynn Lewis,Abigail Millings,Alan A Montgomery,Rob Anderson

doi:10.1186/1745-6215-11-114

Abstract

BackgroundDepression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches.Study DesignA pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16). The unit of allocation is year groups (n = 28) which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm.DiscussionAs of August 2010, all 28 year groups (n = 5023) had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011.Trial RegistrationISRCTN19083628

Highlights

Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood
Epidemiological studies suggest that over a six month period up to 8% of adolescents suffer from a major depressive disorder [1]
Sub-threshold depressive symptoms in adolescence carry a similar risk to major depression for developing depression and suicidal behaviours later in life [6]

Summary

Background

Epidemiological studies suggest that over a six month period up to 8% of adolescents suffer from a major depressive disorder [1]. A recent review identified almost 30 different depression prevention programmes which can be delivered in schools [10] These are either provided universally to all young people irrespective of risk status or in more targeted ways, i.e. to adolescents at increased risk of developing depression or already demonstrating mild/ moderate problems [11]. RAP participants recorded significantly lower levels of depressive symptoms than those in the control condition at both post-intervention and 12-month follow-up. Based on initial depression scores, significantly more (49%) of the at-risk students in the RAP condition moved into the healthy category at post-intervention compared with the control group (35%). This difference was maintained at 12 month follow-up. Most trials are small underpowered efficacy studies which have rarely involved comparisons with other groups

Methods and design

32. Rosenberg M

Findings

34. Goodenow C