Status:
COMPLETED
Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
West Virginia University
Conditions:
Type2 Diabetes
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Program ACTIVE II is a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R18DK092765) designed to test the combined effectiveness of two behavioral treatments for d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03371940
Start Date
January 1 2012
End Date
July 31 2017
Last Update
May 28 2024
Active Locations (3)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
Ohio University
Athens, Ohio, United States, 45701
3
West Virginia University
Morgantown, West Virginia, United States, 26506