Condition category
Mental and Behavioural Disorders
Date applied
19/04/2010
Date assigned
27/05/2010
Last edited
11/01/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.warwick.ac.uk/go/psywell

Contact information

Type

Scientific

Primary contact

Dr John Powell

ORCID ID

Contact details

Health Sciences Research Institute
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The PsyWell study: A randomised controlled trial of an internet-based cognitive behaviour therapy based training programme to improve psychological wellbeing

Acronym

PSYWELL

Study hypothesis

A self-delivered online CBT-based training programme can promote mental wellbeing in the general population

Ethics approval

The Black Country NHS Research Ethics Committee (NRES) approved in March 2010 (ref: 10/H1202/21)

Study design

Randomised controlled trial with two arms: intervention and waiting-list control

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Please use the contact details below to request a patient information sheet

Condition

Mental wellbeing

Intervention

Intervention group receive access to MoodGYM. MoodGYM is a 5 week program comprising of 5 interactive modules, a series of quizzes and 29 exercises. The modules provide training in techniques of cognitive therapy (cognitive restructuring), behavioural methods for overcoming dysfunctional thinking, relaxation, problem solving, assertiveness and self-esteem training, and strategies for coping with relationship break-up. The ‘quizzes’ include a series of anxiety and depression scales (that permit the user to track the change in their symptoms across modules) and a range of other measures (such as quizzes which assist the user to understand their particular profile of thinking patterns or to identify their preferred and actual pleasant events profile). Feedback on the quizzes is based on normative data collected from large scale epidemiological surveys. Users can consult their workbook containing completed exercises at any time. At the end of each module, the user can, if they wish, print out a summary of their session, including the level of their depressive and anxiety symptoms, their scores on other tasks, their goals and achievements. This summary is written in a format that is intended to be taken to the person’s health practitioner should this be deemed appropriate by the user. The user is provided with a personalised certificate of completion at the end of the five modules.
Participants in the intervention arm will receive weekly email reminders to log into the trial portal where they can access the intervention.

Comparison group is a waiting list control who will receive access to MoodGYM after 3 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mental wellbeing, comparing changes from baseline to follow-up at 6 weeks and 3 months. This will be measured using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).

Additional information added as of 08/12/2010:
Updated prior to final outcome measures being measured in the trial to give additional information on ISRCTN, as advised by our steering group. No changes made to original plans, just further information for the purposes of providing full information and clarity.

The primary outcome will be changes from baseline on the WEMWBS mental wellbeing scale, comparing the repeated measures (6 weeks, and 12 weeks) between the two groups. We will use mixed-model repeated-measures ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. We will compare changes from baseline in each group at 6-weeks post-test, and 12 week follow-up. We will use the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).

Co-variates are: age, sex, educational level, employment status, ethnic group, baseline marital status, baseline general health, baseline smoking status, baseline mental health scores, baseline physical activity, baseline alcohol use, baseline drug use, previous mental health service use, previous internet use and experience, previous experience of CBT, previous experience of internet-based CBT.

Secondary outcome measures

The following measured at 6 weeks and 3 months:
1. Depression (CES-D)
2. Anxiety (GAD-7)
3. Quality of life (EQ5D)
4. Physical activity (self-report)
5. Health service use (self-report)

Additional information added as of 08/12/2010:
Updated prior to final outcome measures being measured in the trial to give additional information on ISRCTN, as advised by our steering group. No changes made to original plans, just further information for the purposes of providing full information and clarity.

Secondary outcomes will be changes from baseline for depression scores, anxiety scores, quality of life measurement, and for physical activity, and for health service use, measured at baseline and 12 weeks. We are measuring these using the CES-D (depression), GAD-7 (anxiety), EQ5D (quality of life), the single-item measure of physical activity, and self-report of health service use of number of attendances in primary care, secondary care outpatients, and secondary care inpatient stays. We will also compare self-rated general health.

Co-variates are: age, sex, educational level, employment status, ethnic group, baseline marital status, baseline general health, baseline smoking status, baseline mental health scores, baseline physical activity, baseline alcohol use, baseline drug use, previous mental health service use, previous internet use and experience, previous experience of CBT, previous experience of internet-based CBT.

We will also undertake the following pre-specified sub-group analyses, comparing primary and secondary outcome measures for the following subgroups:
1. Age groups: we have an a priori hypothesis that MoodGYM may be of more benefit to a young age group as it was originally developed for this group. We will therefore undertake a subgroup analysis for the age group aged 25 and younger (and compare with the group aged over 25).
2. Gender: male and female. There is some research to suggest gender differences in mental wellbeing and in response to psychological intervention. We will therefore undertake a subgroup analysis by gender (male and female subgroups).
3. Educational level: as this is an information based intervention it is possible that those with a higher level of education and literacy may do better. We will therefore analyse subgroups by educational level. We will analyse two subgroups:
3.1. Those with a degree level qualification or higher
3.2. Those without
4. Previous psychiatric history: we will compare those who have previously received treatment for a mental health problem to those without this history.
5. Previous experience of cognitive behavioural therapy: we will compare those with previous experience of cognitive behavioural therapy to those without.
6. Depression: we will compare those who are indicated to have depression at baseline (using CES-D), to those who do not.
7. Anxiety: we will compare those who are indicated to have anxiety at baseline (using GAD-7) to those who do not.

Overall trial start date

01/06/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18 or over
2. Located in England
3. Able to read and write English
4. Have access to the internet in order to use the intervention
5. Have an email address where they can be contacted
6. Give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2040

Participant exclusion criteria

1. Aged under 18
2. Located outside England
3. Unable to read and write English
4. Unable to access the intervention
5. No email address provided
6. Email address has already been registered as a trial participant
7. No consent given

Recruitment start date

01/06/2010

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Sciences Research Institute
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/services/rss/

Funders

Funder type

Government

Funder name

Department of Health/NHS Choices (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23302475

Publication citations

  1. Results

    Powell J, Hamborg T, Stallard N, Burls A, McSorley J, Bennett K, Griffiths KM, Christensen H, Effectiveness of a web-based cognitive-behavioral tool to improve mental well-being in the general population: randomized controlled trial., J. Med. Internet Res., 2013, 15, 1, e2, doi: 10.2196/jmir.2240.

Additional files

Editorial Notes