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| [ Print-friendly version ] |
| The effectiveness of a new computerised treatment, "Stressbusters", for young people (aged 11 to 16 years) with symptoms of depression |
| ISRCTN | ISRCTN83507297 |
| ClinicalTrials.gov identifier | |
| Public title | The effectiveness of a new computerised treatment, "Stressbusters", for young people (aged 11 to 16 years) with symptoms of depression |
| Scientific title | Randomised controlled trial (RCT) comparing a computerised Cognitive Behavioural Therapy (CBT) program, called “Stressbusters”, to a wait-list control condition, in young people aged 11-16 years |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
To evaluate the effectiveness of a recently developed computerised Cognitive Behavioural Therapy (C-CBT) program (called “Stressbusters”) for the school- based treatment of depressive symptoms in young people.
Principal research question: For young people aged 11-16 years who have mild-moderate symptoms of depression (as identified in Part 1 of the project), is weekly use of the Stressbusters C-CBT program in school for 8-weeks associated with significant reductions in symptoms of depression, relative to a waiting list control condition (Part 2)? Primary hypothesis: At post treatment follow-up, young people who were randomly allocated to the Stressbusters group will have significantly fewer symptoms of depression, ascertained by scores on a standardised self report measure of depressive symptoms (the Mood and Feelings Questionnaire, MFQ, see below), compared to young people who were randomly allocated to the Wait List group, after controlling for initial symptom severity. This will be tested using Analysis of Covariance (ANCOVA). Secondary hypotheses: 1. At post treatment follow-up, young people who were randomly allocated to the Stressbusters group will have significantly fewer symptoms of anxiety, ascertained by scores on a standardised self report measure of anxiety symptoms (Screen for Anxiety and Related Disorders, SCARED, see below), compared to young people who were randomly allocated to the Wait List group, after controlling for initial symptom severity. This will be tested using Analysis of Covariance (ANCOVA) 2. At post treatment follow-up, young people who were randomly allocated to the Stressbusters group will have significantly fewer symptoms of depression, anxiety, and emotional and behavioural problems as reported by parents and teachers using standardised report measures (MFQ-Parent report, SCARED-Parent report, Strengths and Difficulties Questionnaire for parents and teachers, see below), compared to young people who were randomly allocated to the Wait List group, after controlling for initial symptom severity. This will be tested using Multivariate Analysis of Covariance (MANCOVA) 3. Effects of treatment will be mediated by changes in young people’s thinking styles (measured using the Ruminative Response Styles Questionnaire, see below). This will be tested using a series of regression equations. |
| Lay summary | Lay summary under review |
| Ethics approval | Nursing & Midwifery Research Ethics Committee, King’s College London, 27 July 2010, ref: PNM/09/10-123 |
| Study design | Interventional randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Depression |
| Participants - inclusion criteria |
Part 1 (screening stage):
All consenting young people (male and female), in Years 7 to 12 (aged 11-16 years) attending mainstream secondary school. Part 2 (Stressbusters RCT): 1. Young people (male and female), aged 11-16 years old currently experiencing significant symptoms of depression, as identified in Part 1. 2. A score of 20 or greater on a brief standardised self report measure of depression for young people, the Mood & Feelings Questionnaire (MFQ, Angold, Costello, et al 1987). This well-established threshold has 70% sensitivity and 81% specificity for detecting any mood disorder, including Major Depression and Dysthymia (Daviss et al 2006). |
| Participants - exclusion criteria |
Part 1 (screening stage):
Young people who are unable to read English. Part 2 (Stressbusters RCT): 1. Young people who are receiving treatment for a mood disorder from their GP or local CAMHS clinic 2. Those reporting significant current risk of suicide |
| Anticipated start date | 11/03/2011 |
| Anticipated end date | 30/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Part 1: 900 participants to be screened (part 1) over both sites. Part 2: 146 to be recruited into RCT (part 2) in total (73 in each group) |
| Interventions |
Randomised controlled trial comparing Stressbusters to wait-list control, conducted out of two secondary schools. Individual randomisation, stratified according to age, gender, and symptom severity.
Computerised CBT treatment called Stressbusters compared with “waitlist control” group. Stressbusters consists of eight weekly sessions delivered over nine to 11 weeks (one school term). Each session lasts 30 to 40 minutes. Follow up assessment to take place immediately post treatment and at three and six months post treatment. |
| Primary outcome measure(s) | Severity of depression symptoms, as measured by the self-report Mood and Feelings Questionnaire (MFQ; Costello and Angold, 1988). The MFQ is to be administered pre- and post-intervention and again at three and six months follow up. |
| Secondary outcome measure(s) |
1. Severity of self-reported anxiety symptoms, as measured by the Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 2002). The SCARED is to be administered pre- and post-treatment and again at three and six months follow up.
2. Severity of depression, anxiety, and emotional and behavioural problems as reported by parents and teachers using standardised report measures (MFQ-Parent report; SCARED-Parent report, Strengths and Difficulties Questionnaire for teachers). These measures are to be administered pre- and post-treatment and again at three and six months follow up. 3. Changes in young peoples thinking styles, as measured by the Children’s Response Style Questionnaire (CRSQ; Abela, Brozina, & Haigh, 2002). |
| Sources of funding | Guy's and St Thomas' Charity (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Patrick Smith |
| Address |
Institute of Psychiatry
Department of Psychology King's College London De Crespigny Park |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Sponsor | King's College London (UK) |
| Address |
c/o Mr Keith Brennan
Hodgkin Building Guy's Campus |
| City/town | London |
| Zip/Postcode | SE1 1UL |
| Country | United Kingdom |
| Tel | +44 (0)20 7848 6960 |
| Fax | +44 (0)20 7848 6394 |
| keith.brennan@kcl.ac.uk | |
| Sponsor website: | http://www.kcl.ac.uk/index.aspx |
| Date applied | 07/10/2011 |
| Last edited | 21/12/2011 |
| Date ISRCTN assigned | 21/12/2011 |
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