Co-morbid depression and type 2 diabetes Other
Conditions
Interventions
Individuals with a confirmed diagnosis of type 2 diabetes and depression will be screened to confirm eligibility criteria and will be recruited after written informed consent. On completion of the bas
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals seeking outpatient diabetes care in the DiaDeM study sites in Bangladesh and Pakistan with the following characteristics will be included: 1. Age >18 years old at the time of screening/recruitment 2. Confirmed physician diagnosis of type 2 diabetes based on standardised diagnostic criteria (clinical presentation and HbA1C levels) and registered at the diabetes centre 3. Scoring =3 on the Patient Health Questionnaire-2 (PHQ-2) depression screening tool, and subsequently scoring =5 on the Patient Health Questionnaire (PHQ-9) and confirmed diagnosis of depression using depression schedule A of the Structured Clinical Interview for DSM-V-Research Version (SCID-V-RV) 4. Willingness to attend BA sessions in person or remotely
Exclusion criteria
Exclusion criteria: 1. Currently receiving psychotherapy for depression at the time of screening/recruitment 2. Unable to provide consent due to cognitive impairment or psychological or physical illness severity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of depressive symptoms assessed using the PHQ-9 instrument at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes will be assessed at the 6- and 12-month follow-up timepoints: 1. Depression caseness and severity assessed using the PHQ-9 instrument 2. Anxiety assessed using the Generalised Anxiety Disorder (GAD-7) 3. Diabetes self-management assessed using three measures: the Diabetes Empowerment Scale Short Form (DES-SF), the Perceived Diabetes Self-Management Scale (PDSMS) and the Summary of Self-Care Diabetes Activities scale (SDSCA) 4. Glycemic control (HbA1C) assessed using participant blood samples 5. Body mass index (kg/m²) calculated using height (m) and weight (kg) measurements recorded by the research assistant 6. Diabetes distress assessed using the Problem Areas in Diabetes (PAID-5) scale 7. Cardio-metabolic outcomes: 7.1. Waist circumference: two repeated readings will be recorded in centimetres with a precision of 0.1 cm 7.2. Hip circumference: two repeated readings will be recorded in centimetres with a precision of 0.1 cm 7.3. Waist-hip ratio: measured by dividing the waist circumference by the hip circumference 7.4. Blood pressure and heart rate measured with the help of an automated blood pressure measuring instrument (OMRON®) 7.5. Lipid function including total cholesterol (TC), high-density lipoprotein cholesterol (HDLC) and low-density lipoprotein cholesterol (LDLC) 8. Health-related quality of life measured using the EQ-5D-5L instrument 9. Healthcare costs through participant self-report, recorded in the follow-up questionnaires 10. Adverse and severe adverse events recorded using an adverse event checklist 11. Economic outcomes (employment status, productivity loss, out-of-pocket payments, opportunity costs of time, borrowing and selling of assets, household expenditure and catastrophic health spending) assessed using a set of questions in the follow-up assessment | — |
Countries
Bangladesh, Pakistan
Contacts
Public ContactFaiza Aslam
Outcome results
None listed