N/A
Completed N=140
Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Type2 Diabetes · Depression
Source: ClinicalTrials.gov NCT03371940 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Change in HbA1c — 0.06; -0.03; -0.17; 0.20 percentage of glycosylated hemoglobin
Summary
Program ACTIVE II is a depression treatment study sponsored by the National Institutes of Health, Indiana University, Ohio University and West Virginia University. The purpose of this study is to test the effectiveness of two forms of treatment for depression for adults with type 2 diabetes: talk therapy (counseling) and exercise. Both of these forms of treatment have been proven to be effective in helping people with depression alone. In this study, the investigators will test to see if both of these approaches may be more effective in helping people live depression-free compared to talk therapy, exercise or usual care alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
0.06; -0.03; -0.17; 0.20 | — |
| PRIMARY Change in Depression Status - Beck Depression Inventory |
-15.24; -14.11; -18.12; -8.21 | — |
| PRIMARY Change in Depression Status - Diagnosis of Major Depressive Disorder |
16; 21; 17; 9 | — |
| SECONDARY Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT) |
-6.16; 65.60; 0.74; 23.68 | — |
Eligibility Criteria
Inclusion Criteria
- able to walk without the use of a cane or walker
- diagnosis of type 2 diabetes for at least one year duration or longer
- major depression lasting two weeks or longer
Exclusion Criteria
- history of diabetic ketoacidosis (DKA)
- history of continuous insulin therapy since diabetes diagnosis
- stage 2 hypertension as defined by JNC VII
- recent cardiac events (e.g., unstable angina, diagnosed angina, PTCA, any cardiac intervention for CAD or tachydysrhythmias in the past six months)
- laser surgery for proliferative retinopathy in the past six months
- history of stroke, lower limb amputation, asensory peripheral neuropathy, aortic stenosis or other sever valvular heart disease, atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure
- active suicidal ideation or history of suicide attempt
- history of bipolar disorder
- history of psychotic disorder
- current substance abuse or dependence disorder
- individuals who report the use of a current antidepressant medication for five weeks or less were excluded or deferred for later screening after the 6 week period
- individual who were receiving psychotherapy from a mental health provider for depression were excluded
Data sourced from ClinicalTrials.gov (NCT03371940). 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.