Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pooria Sarrami Foroushani

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6027

Study information

Scientific title

Computerised cognitive behavioural therapy (CBT) for common mental disorders: a randomised controlled trial (RCT) of a workplace intervention

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient 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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

26/06/2009

Overall trial end date

15/11/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 535

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

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

The Institute of Mental Health (UK)

Sponsor details

Sir Colin Campbell Building
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Sponsor type

Research organisation

Website

http://www.institutemh.org.uk/

Funders

Funder type

Charity

Funder name

British Occupational Health Research Foundation (BOHRF) (UK)

Alternative name(s)

BOHRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23795621
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24681717

Publication citations

  1. Results

    Phillips R, Schneider J, Molosankwe I, Leese M, Foroushani PS, Grime P, McCrone P, Morriss R, Thornicroft G, Randomized controlled trial of computerized cognitive behavioural therapy for depressive symptoms: effectiveness and costs of a workplace intervention., Psychol Med, 2014, 44, 4, 741-752, doi: 10.1017/S0033291713001323.

  2. Results

    Schneider J, Sarrami Foroushani P, Grime P, Thornicroft G, Acceptability of online self-help to people with depression: users' views of MoodGYM versus informational websites., J. Med. Internet Res., 2014, 16, 3, e90, doi: 10.2196/jmir.2871.

Editorial Notes