Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

Depression Clinical Trial

Official title:

Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371940
• Other study ID #: 1308973934
• Secondary ID: R18DK092765
• Status: Completed
• Phase: N/A
• First received: December 5, 2017
• Last updated: December 8, 2017
• Start date: January 1, 2012
• Est. completion date: July 31, 2017

Study information

• Verified date: December 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 31, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Behavioral:
• Program ACTIVE Exercise
Please see the Exercise arm description above.
• Program ACTIVE CBT
Please see the Talk Therapy arm description above.
• Program ACTIVE
Please see the Talk Therapy + Exercise arm description above.
• Usual Care - No intervention
Please see the Usual Care arm description above.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	West Virginia University	Morgantown	West Virginia

Sponsors (5)

Lead Sponsor	Collaborator
Indiana University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio University, University of Michigan, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2016 Oct 11. — View 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). doi: 10.16966/2380-5544.108. Epub 2015 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Based on our 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.	following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention
Primary	Change in depression status - Beck Depression Inventory	Participants in the CBT, EXER and CBT + EXER conditions will show clinically significant improvements in BDI at POST, 6- and 12-month assessments with the greatest improvements expected among those in CBT + EXER condition. Based on pilot data, 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.	following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention
Primary	Change in depression status - Diagnosis of Major Depressive Disorder	Participants in the CBT, EXER and CBT + EXER conditions will show clinically significant improvements in diagnosis of MDD at POST, 6- and 12-month assessments with the greatest improvements expected among those in CBT + EXER condition. Based on pilot data, a) 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, 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.	following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention
Secondary	Changes in cardiovascular (CVD) risk factors	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.	following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention
Secondary	Cost effectiveness analyses	The cost of predicted incidence of complications, particularly coronary heart disease (CHD), will be lower among those who receive the 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.	following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention