Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Type2 Diabetes, Depression
About this trial
This is an interventional treatment trial for Type2 Diabetes
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
Sites / Locations
- Indiana University
- Ohio University
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Talk therapy (CBT)
Exercise (EXER)
Talk therapy + exercise (CBT+EXER)
Usual care (UC)
Participants randomized the talk therapy arm received 10 weeks of CBT or "talk therapy." The goal of CBT was to provide individuals with skills and concepts that they may use to: 1) manage and reduce depressive symptoms; 2) prevent the onset and severity of future depressive episodes; and 3) generalize these skills to diabetes management. CBT interventionists facilitated patient management of depressive symptoms by providing participants with: Education about depression and the cognitive-behavioral therapy model; A safe relationship for participants to explore their symptom patterns and try to new tools to address them; Coaching as participants fully engage emotional and behavioral strategies.
Participants randomized to the exercise arm were enrolled in a 12-week physical activity intervention designed to increase aerobic physical activity. Participants were asked to complete 100 minutes of aerobic activity in Week 1, 125 minutes in Week 2, and 150 minutes per week of physical activity in Weeks 3-12. In addition, participants received 6 exercise training classes in which safe exercise practices were introduced and practiced, free access to a local exercise facility, use of a pedometer, completion of activity logs each week, and received an exercise workbook that addressed social and motivational aspects of physical activity.
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Participants randomized to usual care received no study intervention.