INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study (INDEPENDENT)
Diabetes, Depression, Cardiovascular Risk Factor
About this trial
This is an interventional health services research trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Age ≥35 years
- Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
- PHQ-9 score≥10
- ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used
- Willingness to consent to randomization.
Exclusion Criteria:
- The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral
- Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
- Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)
- Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
- Pregnancy or breastfeeding
- Documented CVD event (MI, stroke) in past 12 months
- End-stage renal disease awaiting transplant
- Malignancy or life-threatening disease with death probable in 3 years
- Alcohol or drug abuse
- No fixed address or contact details.
Sites / Locations
- Diacon Hospital, Diabetes Care and Research Center
- Madras Diabetes Research Foundation
- All India Institute of Medical Sciences
- Endocrine Diabetes Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention Program of Care
Control Arm
Patient Education and Behavioral Activation by a Care Coordinator; Supporting Self-Care; Psychiatrist and Diabetologist Reviews; and Decision-support Electronic Health Record System
Participants randomized to the control arm will receive the existing standard of care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.