INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

Emory University

Status: Completed

Conditions: Diabetes; Depression; Cardiovascular Risk Factor

Treatments: Other: Decision-support Electronic Health Record System; Behavioral: Supporting Self-Care (care coordinators); Other: Psychiatrist and Diabetologist Reviews; Other: Standard of Care; Behavioral: Patient Education and Behavioral Activation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02022111

IRB00064913

R01MH100390-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at four diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.

Full description

It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial.

Enrollment: 404 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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404 participants in 2 patient groups, including a placebo group

Intervention Program of Care

Active Comparator group

Description:

1. Patient Education and Behavioral Activation by a Care Coordinator; 2. Supporting Self-Care; 3. Psychiatrist and Diabetologist Reviews; and 4. Decision-support Electronic Health Record System

Treatment:

Behavioral: Supporting Self-Care (care coordinators)

Behavioral: Patient Education and Behavioral Activation

Other: Decision-support Electronic Health Record System

Other: Psychiatrist and Diabetologist Reviews

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard of Care