Sponsor study identifier
Secondary identifiers
NIH
interventional
140
1 country
3
Study Start
January 1, 2012
Actual (reported)Primary Completion
June 30, 2016
Actual (reported)Study Completion
July 31, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2012
Actual (reported)June 30, 2016
Actual (reported)July 31, 2017
Actual (reported)December 5, 2017
Actual (reported)December 13, 2017
Actual (reported)May 28, 2024
Actual (reported)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 (\~3 month) compared to baseline (de Groot et al., 2009).
following completion of intervention (POST; ~3 months)
Change in Depression Status - Beck Depression Inventory
The BDI total score is a sum of 21 items (score range 0 - 63) with higher scores indicating greater depression symptomatology. We calculated change scores from baseline to POST (\~3 months). Negative values indicate improvements in depression symptoms. Positive values indicate worsened depression symptoms.
following completion of intervention (POST; ~3 months)
Change in Depression Status - Diagnosis of Major Depressive Disorder
Data presented below is the proportion of participants in each treatment arm that achieved partial or full remission from MDD at POST (\~3 months) intervention per the Structured Clinical Interview for the DSM-IV.
following completion of intervention (POST; ~3 months)
Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT)
following completion of intervention (POST; ~3 months)
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.
Please see the Exercise arm description above.
Please see the Talk Therapy arm description above.
Indiana University
Indianapolis, Indiana, 46202, United States
Ohio University
Athens, Ohio, 45701, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
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.
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.
Predominantly female/relatively small sample sizes in subgroup analyses-may have limited statistical significance. Larger sample size may reach statistical significance. Confidence intervals observed in the OR of depression remission in CBT group may indicate limited reliability of this estimate. Participants may not generalize to all adults with T2DM \& MDD.
140 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2017
First Posted
December 13, 2017
Study Start
Minimal Psychological Intervention in Diabetes Patients
Participants randomized to the combination therapy received both talk therapy and exercise concurrently over a 12-week period as detailed above.
Participants randomized to usual care received no study intervention.
Please see the Talk Therapy + Exercise arm description above.
Please see the Usual Care arm description above.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
January 1, 2012
Actual (reported)Primary Completion
June 30, 2016
Actual (reported)Study Completion
July 31, 2017
Actual (reported)Last Updated
May 28, 2024
Results First Posted
May 28, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: