Diabetes and depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Trial status amended to 'stopped' as of 05/04/2013 due to notification of lack of staff/resources.
Control arm: Treatment as usual
Intervention arm: Treatment as usual plus computerised cognitive beh
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be recruited from a diabetic clinic, therefore all participants will be diabetic. Inclusion criteria: 1. Both males and females, aged 18 and above 2. Currently experiencing depression as defined by a score of 10 or greater on the Patient Health Questionnaire 9 (PHQ-9) 3. Able and to use the computerised cognitive behavioural therapy (CCBT) package (have access to computer and broadband internet and an active e-mail address) 4. Willing to use the CCBT self-help package
Exclusion criteria
Exclusion criteria: 1. Not fluent in the English language (unable to read/write or communicate) 2. Alcohol intake above 31 and 22 units for men and women, respectively (1.5 times the current recommended maximum drinking levels) 3. Drug dependency defined as using street drugs everyday 4. Those who are actively suicidal, as defined by a score of 2 or more on the Beck Depression Inventory II (BDI-II) suicide item 5. Those who have received access to supported self-help in the last 6 months 6. Involved in other clinical research studies 7. Past or current history of psychosis or bipolar disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in depression as measured by BDI-II, assessed at baseline, Month 4, 5 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety state and other depression measures will be carried out using the Hospital Anxiety and Depression Scale (HADS)and PHQ-9 at baseline, Month 4, 5 and 12 2. Social functioning will be measured using the Work and Social Adjustment Scale (WASAS) at baseline, Month 4, 5 and 12 3. Mental health literacy will be measured using a revised questionnaire from previous studies at baseline, Month 4, 5 and 12 4. Acceptability of the trial interventions will be measured using two satisfaction items asking overall satisfaction with the treatment option at Month 4 and 12 (this is in line with other similar studies) 5. Health care usage/costs will be costed using the Client Service Receipt Inventory (modified) and euroquol EQ-5D at baseline, Month 4, 5 and 12 6. Diabetes status: Hb1Ac will be sought using routine clinical data from clinical notes In addition, a qualitative interview will be carried out in a subset of participants from both arms at 5 months, to collect data for the following aspects of the self-help CCBT: 1. Personal experience of low mood 2. Interaction with support worker 3. First and subsequent experiences of CCBT 4. Outcome of CCBT | — |
Countries
United Kingdom
Outcome results
None listed