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| [ ...Back to search results ] | [ Print-friendly version ] |
| Computerised cognitive behavioural therapy (CBT) for common mental disorders |
| ISRCTN | ISRCTN24529487 |
| ClinicalTrials.gov identifier | |
| Public title | Computerised cognitive behavioural therapy (CBT) for common mental disorders |
| Scientific title | Computerised cognitive behavioural therapy (CBT) for common mental disorders: a randomised controlled trial (RCT) of a workplace intervention |
| Acronym | N/A |
| Serial number at source | 6027 |
| Study hypothesis |
Primary hypothesis:
To test the impact of MoodGYM on employess work related performance and psychological well-being. Secondary hypotheses: 1. To assess the cost effectivenss of MoodGYM in a workplace context 2. To evaluate the acceptability of the intervention and mode delivery |
| Ethics approval | Derbyshire Research Ethics Committee approved on the 6th January 2009 (ref: 08/H0401/91) |
| Study design | Multicentre randomised interventional treatment trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Mental Health Research Network; Subtopic: Anxiety, Depression; Disease: Depression |
| Participants - inclusion criteria |
1. A positive response to any of the questions 1 - 3 of the Brief Patient Health Questionnaire (PHQ-Brief), indicating:
1.1. Major depression 1.2. Other depressive syndromes (2 - 5 symptoms more than half the days over 2 weeks affecting function at home, work or socially), or 1.3. Panic syndrome (at least one panic in the last 4 weeks affecting function at home, work or socially) Mood Gym is supposed to manage all these problems and any of them is likely to lead to problems at work. OR 2. On Patient Health Questionnaire-9 (PHQ-9), employee scores 2 or more on 5 of the 9 items including 2 on item 1 or 2 and "somewhat difficult" on item 10 (function). These scores are equivalent symptomatically to a diagnosis of major depression AND 3. Age over 18 years and under 65 years, either sex |
| Participants - exclusion criteria |
1. Has a primary alcohol or drug use problem
2. Depression secondary to organic brain disease, e.g., stroke 3. Bipolar disorder or other serious mental illness apart from unipolar depression 4. Is already receiving cognitive behaviour therapy 5. Has current suicide plans requiring emergency psychiatric treatment 6. Does not or cannot give written informed consent to the study |
| Anticipated start date | 26/06/2009 |
| Anticipated end date | 15/11/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact selfhelp@nottingham.ac.uk or Justine.Schneider@nottingham.ac.uk to request a patient information sheet |
| Target number of participants | Planned sample size: 535 |
| Interventions |
MoodGYM is a modularised course, designed to last 6 weeks, which participants will follow at their own pace. Weekly, brief (10-minute) calls will be made to check on use of MoodGYM or other services (e.g., health care, counselling, medication) used by by the intervention group and any services which the control group uses over the first 6 weeks in the study.
Study entry: registration and one or more randomisations |
| Primary outcome measure(s) |
1. Patient Health Questionnaire (PHQ9)
2. Work Limitations Questionnaire, WLQ 3. Generalised Anxiety Disorder Assessment (GAD7) Measured at baseline, 6 weeks and 12 weeks. |
| Secondary outcome measure(s) |
1. Clinical Outcomes in Routine Evaluation (CORE10)
2. Work and Social Attitudes Scale (WSAS) Measured at baseline, 6 weeks and 12 weeks. |
| Sources of funding | British Occupational Health Research Foundation (BOHRF) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Pooria Sarrami Foroushani |
| Address |
School of Sociology and Social Policy
University Park |
| City/town | Nottingham |
| Zip/Postcode | NG7 2RD |
| Country | United Kingdom |
| Sponsor | The Institute of Mental Health (UK) |
| Address |
Sir Colin Campbell Building
University of Nottingham Innovation Park Triumph Road |
| City/town | Nottingham |
| Zip/Postcode | NG7 2TU |
| Country | United Kingdom |
| Sponsor website: | http://www.institutemh.org.uk/ |
| Date applied | 12/05/2010 |
| Last edited | 26/05/2010 |
| Date ISRCTN assigned | 12/05/2010 |
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