Assessing the feasibility of delivering a behavioural activation intervention to people with diabetes and depression in South Asia

INTERVENTION: A computer‐generated blocked stratified (by country) randomisation sequence is created using Stata version 15, with an allocation ratio of 1:1. Intervention: Behavioural Activation ‐ structured individual therapy delivered by Behavioural Activation facilitators based in diabetes services, supported by a treatment manual and participant’s and facilitator’s booklets, with supervision by a mental health specialist. Six 30‐40 minutes sessions over a period of 6 to 12 weeks will be offered. The sessions will be delivered either face to face or remotely according to the participant’s preference. The ‘optimised usual care’ information leaflet will also be offered. Control group: Provision of an ‘optimised usual care’ information leaflet, describing depression and its treatment and details of how to access help locally. CONDITION: Type 2 diabetes with confirmed mild, moderate or severe depression ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; 1. Recruitment rates, assessed as the number of participants eligible, consenting and randomised out of those screened at recruitment. These will be assessed on the completion of the recruitments at all study sites.; 2. Reasons for ineligibility/non‐participation/non‐consent of participants assessed through a review of trial screening logs. This will be assessed on the completion of the recruitments at all study sites; 3. Retention rates for the feasibility trial: proportion of randomised participants who were successfully followed up at 3 and 6 months post‐randomisation; 4. Retention rates for the DiaDeM intervention: number of intervention sessions attended out of the total number of sessions offered. This will be assessed 6 months post‐randomisation for all recruited and randomised participants.; 5. Reasons for discontinuation of BA intervention sessions assessed through a review of the BA facilitators' logs. This will be assessed 6 months post‐randomisation for all recruited and randomised participants. The logs will record the information regarding session appointments, attendance, drop‐out and delivery. The qualitative analysis of the in‐depth interviews of participants and facilitators during process evaluation will also provide additional information regarding the barriers affecting the intervention delivery.; 6. The length of time taken to attain the required sample size will be assessed as the mean of the number of days taken from the date of commencement of recruitment till the date of last recruitment at each site; 7. Data completeness for all the baseline and follow‐up variables and tools at baseline, 3 and 6 months. Problem areas and solutions will be identified for DiaDeM‐Work Stream 3 full trial; SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Adults (=18 years old) with confirmed type 2 diabetes mellitus 2. Score =3 on the PHQ‐2 scale 3. Classified as having mild, moderate or severe depression (using a cut‐off score of =5) on the PHQ‐9 4. Confirmatory diagnosis of depression using the MINI mental‐state examination scale 5. Willing to participate and able to attend therapy sessions in person or remotely.