The PsyWell study: promoting Psychological Wellbeing using an internet-based training programme

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.

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.