Computerised cognitive behavioural therapy (CBT) for common mental disorders
| ISRCTN | ISRCTN24529487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24529487 |
| Secondary identifying numbers | 6027 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 01/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Pooria Sarrami Foroushani
Scientific
Scientific
School of Sociology and Social Policy
University Park
Nottingham
NG7 2RD
United Kingdom
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact selfhelp@nottingham.ac.uk or Justine.Schneider@nottingham.ac.uk to request a patient information sheet |
| Scientific title | Computerised cognitive behavioural therapy (CBT) for common mental disorders: a randomised controlled trial (RCT) of a workplace intervention |
| 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(s) | Derbyshire Research Ethics Committee approved on the 6th January 2009 (ref: 08/H0401/91) |
| Condition | Topic: Mental Health Research Network; Subtopic: Anxiety, Depression; Disease: Depression |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 1. Clinical Outcomes in Routine Evaluation (CORE10) 2. Work and Social Attitudes Scale (WSAS) Measured at baseline, 6 weeks and 12 weeks. |
| Overall study start date | 26/06/2009 |
| Overall study end date | 15/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 535 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 26/06/2009 |
| Recruitment end date | 15/11/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Sociology and Social Policy
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Sponsor information
The Institute of Mental Health (UK)
Research organisation
Research organisation
Sir Colin Campbell Building
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
| Website | http://www.institutemh.org.uk/ |
|---|---|
"ROR" |
https://ror.org/015dvxx67 |
Funders
Funder type
Charity
British Occupational Health Research Foundation (BOHRF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BOHRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | Yes | No | |
| Results article | results | 28/03/2014 | Yes | No |
