Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

Nov 2, 2014BMJ open

Testing computer-based therapy for depression in teenagers: plan for a trial to check if it works

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Abstract

The 1-year prevalence of depression in adolescents is about 2%.

Antidepressant medication is not recommended as initial treatment for adolescents due to high side effects and poor efficacy.
Cognitive behavior therapy (CBT) is effective for treating depression and is a main recommended option for adolescents.
Computer-administered CBT (CCBT) may offer a wider and earlier treatment opportunity for young people with low mood.
The feasibility of conducting a fully powered randomized controlled trial (RCT) for CCBT in adolescents is being assessed.
Primary outcomes will include changes in depression levels measured by the Beck Depression Inventory (BDI).
Data on recruitment, attrition, and questionnaire completion rates will be collected to inform the feasibility analysis.

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INTRODUCTION: The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).

METHODS AND ANALYSIS: Adolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.

ETHICS AND DISSEMINATION: The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).

TRIAL REGISTRATION NUMBER: ISRCTN31219579.

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Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

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