Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

Completed · Not applicable

Conditions studied: Type2 Diabetes, Depression

In brief

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.

Key facts

Study ID

NCT03371940

Run by

Indiana University

People needed

140

Starts

2012-01-01

Expected to finish

2017-07-31

Last updated by the study team

2024-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• Ohio University — Athens, Ohio, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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