Randomized controlled trial of DiaDeM, an adapted behavioural activation intervention, for people with depression and diabetes in South Asia

INTERVENTION: 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 baseline Case Report Form (CRF), each recruited participant will be randomly allocated to either the treatment or control arm. Randomization will use a 1:1 allocation ratio and will follow a computer‐generated randomization sequence that will be stratified by country with randomly permuted blocks of varying block sizes and will be generated using Stata version 17 or later. Participants randomized to the DiaDeM Behavioural Activation (BA) intervention group will receive structured individual therapy delivered by BA facilitators based in diabetes clinics, supported by a treatment manual, and a participant and facilitator booklet, with supervision by a mental health specialist. Si X30‐40‐minute sessions over a period of 6 to 12 weeks will be offered. The sessions will be delivered preferably face‐to‐face, or remotely according to the participant s preference. The ‘optimised usual care’ information leaflet will also be offered. Participants in the control group will receive an ‘optimised usual care’ leaflet that includes information on depression, pharmacological and non‐pharmacological treatment options for depression along with the procedures and contacts for accessing help. CONDITION: Co‐morbid depression and type 2 diabetes ; Not Applicable PRIMARY OUTCOME: Severity of depressive symptoms assessed using the PHQ‐9 instrument at 6 months post‐randomisation SECONDARY OUTCOME: 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 inde X(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 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