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Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03371940
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
West Virginia University
Ohio University
University of Michigan
Information provided by (Responsible Party):
Mary de Groot, Indiana University

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date December 13, 2017
Actual Study Start Date  ICMJE January 1, 2012
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Change in HbA1c [ Time Frame: following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention ]
    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.
  • Change in depression status - Beck Depression Inventory [ Time Frame: following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention ]
    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.
  • Change in depression status - Diagnosis of Major Depressive Disorder [ Time Frame: following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Changes in cardiovascular (CVD) risk factors [ Time Frame: following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention ]
    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.
  • Cost effectiveness analyses [ Time Frame: following completion of intervention (~3 months), 6-months following completion of intervention, and 12-months following completion of intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Official Title  ICMJE Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type2 Diabetes
  • Depression
Intervention  ICMJE
  • Behavioral: Program ACTIVE Exercise
    Please see the Exercise arm description above.
  • Behavioral: Program ACTIVE CBT
    Please see the Talk Therapy arm description above.
  • Behavioral: Program ACTIVE
    Please see the Talk Therapy + Exercise arm description above.
  • Behavioral: Usual Care - No intervention
    Please see the Usual Care arm description above.
Study Arms  ICMJE
  • Experimental: Talk therapy (CBT)

    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.
    Intervention: Behavioral: Program ACTIVE CBT
  • Experimental: Exercise (EXER)
    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.
    Intervention: Behavioral: Program ACTIVE Exercise
  • Experimental: Talk therapy + exercise (CBT+EXER)
    Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
    Intervention: Behavioral: Program ACTIVE
  • Placebo Comparator: Usual care (UC)
    Participants randomized to usual care received no study intervention.
    Intervention: Behavioral: Usual Care - No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
140
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03371940
Other Study ID Numbers  ICMJE 1308973934
R18DK092765 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mary de Groot, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • West Virginia University
  • Ohio University
  • University of Michigan
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP