N/A
Completed N=404
INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Diabetes · Depression · Cardiovascular Risk Factor
Source: ClinicalTrials.gov NCT02022111 ↗
Enrolled (actual)
404
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors — 71.6; 54.7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors |
71.6; 54.7 | — |
| SECONDARY Measures of "Common Effect" |
-0.2250; -0.1118; 0.0434 | — |
| SECONDARY Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups |
15.3; 5.5; 7.10; 7.30; 3.10; 2.40 | — |
| SECONDARY Mean Changes in Each of the Four Main Targets: SCL-20 Score |
-0.79; -0.55; -0.94; -0.86; -0.93; -0.96 | — |
| SECONDARY Mean Changes in Each of the Four Main Targets: HbA1c |
-1.12; -0.54; -0.49; -0.24; 0.12; -0.02 | — |
| SECONDARY Mean Changes in Each of the Four Main Targets: SBP |
-6.95; -5.91; -9.81; -9.12; -2.43; -3.69 | — |
| SECONDARY Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl |
-9.47; -7.04; -5.10; -5.16; 9.33; 7.65 | — |
| SECONDARY Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20 |
75.0; 48.0; 82.9; 68.8; 75.2; 73.3 | — |
| SECONDARY Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control |
69.6; 52.5; 53.9; 49.0; 50.0; 46.4 | — |
| SECONDARY Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure |
71.9; 73.8; 74.6; 77.0; 63.4; 73.7 | — |
| SECONDARY Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control |
72.6; 69.8; 66.9; 66.5; 49.7; 56.4 | — |
| SECONDARY Mean Treatment Satisfaction Scores |
2.22; 1.16; 3.43; 3.45 | — |
| SECONDARY Mean Health Expenditures (Direct Medical Costs) |
23423.70; 8674.35; 32119.20; 17957.99; 41808.22; 28242.58 | — |
| SECONDARY Cost Utility in the Treatment Arm and Usual Care Arms |
155,106.5; 121,993.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02022111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.