Welcome
Support Centre
30 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Computerised cognitive behavioural therapy (CBT) for common mental disorders
ISRCTN ISRCTN24529487
DOI 10.1186/ISRCTN24529487
ClinicalTrials.gov identifier
EudraCT number
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
Lay summary Not provided at time of registration
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 Completed
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 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23795621
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24681717
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 01/04/2014
Date ISRCTN assigned 12/05/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.