Clinical trial NCT03371940: Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Official title: Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Depression
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: West Virginia University
name: Ohio University
name: University of Michigan
First posted: 2017-12-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subjects were randomly assigned to one of the four groups: talk therapy, exercise, talk therapy + exercise, or usual care. Separate randomization lists were generated by the study statistician for use by each of the three study sites.
Primary purpose: TREATMENT

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 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.

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 depression in people with type 2 diabetes: individual counseling (cognitive behavioral therapy; CBT) and exercise. While each of these treatment approaches has been tested individually in people with depression, no study has tested the combination of these approaches for people with major depression and type 2 diabetes. These approaches have the potential to work synergistically as a win-win strategy to improve both T2DM and depression outcomes while extending the reach of formal health care treatment strategies for diabetes.

Two primary study aims will be addressed by Program ACTIVE II: 1) to compare changes in glycemic control across intervention groups to UC at POST and 6- and 12-month follow-up assessments; and 2) to compare changes in MDD outcomes across intervention groups (i.e. CBT, EXER, CBT+EXER) to usual care (UC) following intervention (POST) and 6- and 12-month follow-up assessments.

The primary hypotheses are:

1. Diabetes Outcomes. Based on the investigators' pilot data, mean glycemic control (as measured by HbA1c) is expected to improve .4% in participants in the EXER and CBT+EXER treatment conditions at POST compared to baseline \[de Groot et al 2009\]. Participants assigned to the CBT+EXER treatment are expected to show the greatest improvement in HbA1c followed by those in the EXER group in comparison to the CBT group. No improvement is expected among those assigned to the UC condition.
2. Depression. Participants in the CBT, EXER and CBT+EXER conditions will show clinically significant improvements in BDI and diagnosis of MDD at POST and 6- and 12-month assessments with the greatest improvements expected among those in CBT+EXER condition. Based on pilot data, a) 66% reduction in the number of people who meet DSM-IV criteria for MDD is expected at POST compared to baseline; b) 86-90% percent of cases with MDD remission at POST are expected to remain remitted at the 6-month follow-up; c) severity of depression, as measured by the BDI-II, will significantly decrease from baseline to POST and baseline to follow-up assessments, after co-varying the effect of gender, number of T2DM complications, and exposure to treatment. It is anticipated that participants in the CBT+EXER condition will show the longest remission rates of depression followed by those in EXER and CBT.

   The secondary hypotheses are:
3. Changes in CVD risk factors in the intervention groups compared to UC over time. Physical activity capacity, as measured by the 6-minute walk test (6MWT), will demonstrate the greatest improvements in the CBT+EXER arm, closely followed by the EXER arm at follow-up assessment compared to baseline. Participants in the CBT and UC arms are not expected to show significant improvements. LDL-C is expected to improve at POST in the EXER and CBT+EXER conditions consistent with pilot data.
4. Cost Effectiveness Analyses. The predicted incidence of complications, particularly coronary heart disease (CHD), will be lower among those who receive CBT+EXER condition compared to the CBT, EXER and UC conditions. Further, the costs of this intensive intervention will be offset by a decrease in complication incidence.

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

Primary outcomes:
measure: Change in HbA1c
timeFrame: following completion of intervention (POST; ~3 months)
measure: Change in Depression Status - Beck Depression Inventory
timeFrame: following completion of intervention (POST; ~3 months)
measure: Change in Depression Status - Diagnosis of Major Depressive Disorder
timeFrame: following completion of intervention (POST; ~3 months)
Secondary outcomes:
measure: Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT)
timeFrame: following completion of intervention (POST; ~3 months)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Athens
country: United States
facility: Ohio University
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
citation: de Groot M, Shubrook J, Schwartz F, Hornsby WG Jr, Pillay Y, Saha C. Program ACTIVE II: Design and Methods for a Multi-Center Community-Based Depression Treatment for Rural and Urban Adults with Type 2 Diabetes. J Diabetes Res Ther. 2015 Aug;1(2):10.16966/2380-5544.108. doi: 10.16966/2380-5544.108. Epub 2015 Aug 5.
citation: de Groot M, Crick KA, Long M, Saha C, Shubrook JH. Lifetime Duration of Depressive Disorders in Patients With Type 2 Diabetes. Diabetes Care. 2016 Dec;39(12):2174-2181. doi: 10.2337/dc16-1145. Epub 2016 Oct 11.
citation: de Groot M, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Fitzpatrick K, Yang Z, Saha C. Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1185-1193. doi: 10.2337/dc18-2400. Epub 2019 May 21.
citation: Kuo S, Ye W, de Groot M, Saha C, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Herman WH. Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II. Diabetes Care. 2021 Apr;44(4):874-882. doi: 10.2337/dc20-1639. Epub 2021 Feb 19.
citation: Myers BA, Pillay Y, Guyton Hornsby W Jr, Shubrook J, Saha C, Mather KJ, Fitzpatrick K, de Groot M. Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes. Trials. 2019 Nov 6;20(1):621. doi: 10.1186/s13063-019-3712-x.