Screening and support for depression in people with diabetes: a randomised controlled study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2008
INTERVENTION: 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 behavioural therapy (CCBT). The CCBT is a self‐help intervention supported by mental health practitioners. Added as of 24/10/2008: The supported self‐help intervention will comprise 4 support sessions over 6 weeks, and 6 sessions using an online CCBT package. It is approximated that this will take the participants 8 weeks to complete. CONDITION: Diabetes and depression ; Mental and Behavioural Disorders ; Depressive episode PRIMARY OUTCOME: Change in depression as measured by BDI‐II, assessed at baseline, Month 4, 5 and 12. SECONDARY OUTCOME: 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 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
Epistemonikos ID: 23a999add2da86d7ede35db1ec41095a34c6e220
First added on: Aug 21, 2024