Computerised cognitive behavioural therapy (CBT) for common mental disorders

ISRCTN	ISRCTN24529487
DOI	https://doi.org/10.1186/ISRCTN24529487
Protocol serial number	6027
Sponsor	The Institute of Mental Health (UK)
Funder	British Occupational Health Research Foundation (BOHRF) (UK)

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 of protocol

Not provided at time of registration

Contact information

Dr Pooria Sarrami Foroushani
Scientific

School of Sociology and Social Policy
University Park
Nottingham
NG7 2RD
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Computerised cognitive behavioural therapy (CBT) for common mental disorders: a randomised controlled trial (RCT) of a workplace intervention
Study objectives	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)
Health condition(s) or problem(s) studied	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(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.
Key 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.
Completion date	15/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	535
Key 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
Key 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
Date of first enrolment	26/06/2009
Date of final enrolment	15/11/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Sociology and Social Policy

Nottingham
NG7 2RD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes