Trial Outcomes & Findings for Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes (NCT NCT03371940)
NCT ID: NCT03371940
Last Updated: 2024-05-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
following completion of intervention (POST; ~3 months)
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
34
|
36
|
|
Overall Study
COMPLETED
|
28
|
33
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
3
|
4
|
Reasons for withdrawal
| Measure |
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
3
|
4
|
Baseline Characteristics
Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Talk Therapy (CBT)
n=36 Participants
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=34 Participants
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=34 Participants
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=36 Participants
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
55.95 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
36 participants
n=4 Participants
|
140 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: following completion of intervention (POST; ~3 months)Population: Discrepancies between numbers randomized to each treatment and numbers analyzed are due to factors such as: rejection of treatment, seeking treatment from health care provider instead, transportation issues, scheduling issues or being lost to follow-up.
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).
Outcome measures
| Measure |
Talk Therapy (CBT)
n=24 Participants
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=30 Participants
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=25 Participants
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=28 Participants
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Change in HbA1c
|
0.06 percentage of glycosylated hemoglobin
Standard Error 0.13
|
-0.03 percentage of glycosylated hemoglobin
Standard Error 0.13
|
-0.17 percentage of glycosylated hemoglobin
Standard Error 0.13
|
0.20 percentage of glycosylated hemoglobin
Standard Error 0.13
|
PRIMARY outcome
Timeframe: following completion of intervention (POST; ~3 months)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.
Outcome measures
| Measure |
Talk Therapy (CBT)
n=24 Participants
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=30 Participants
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=25 Participants
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=28 Participants
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Change in Depression Status - Beck Depression Inventory
|
-15.24 Change in BDI scores
Standard Error 1.95
|
-14.11 Change in BDI scores
Standard Error 1.91
|
-18.12 Change in BDI scores
Standard Error 1.81
|
-8.21 Change in BDI scores
Standard Error 1.88
|
PRIMARY outcome
Timeframe: following completion of intervention (POST; ~3 months)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.
Outcome measures
| Measure |
Talk Therapy (CBT)
n=24 Participants
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=30 Participants
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=25 Participants
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=28 Participants
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Change in Depression Status - Diagnosis of Major Depressive Disorder
|
16 Participants
|
21 Participants
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: following completion of intervention (POST; ~3 months)Physical activity capacity as measured by the 6-minute walk test (6MWT, measured in feel walked)
Outcome measures
| Measure |
Talk Therapy (CBT)
n=24 Participants
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=30 Participants
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=25 Participants
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=28 Participants
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT)
|
-6.16 change in feet walked
Standard Error 33.03
|
65.60 change in feet walked
Standard Error 32.60
|
0.74 change in feet walked
Standard Error 31.48
|
23.68 change in feet walked
Standard Error 33.26
|
Adverse Events
Talk Therapy (CBT)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Exercise (EXER)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 1 deaths
Talk Therapy + Exercise (CBT+EXER)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Talk Therapy (CBT)
n=36 participants at risk
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.
Program ACTIVE CBT: Please see the Talk Therapy arm description above.
|
Exercise (EXER)
n=34 participants at risk
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.
Program ACTIVE Exercise: Please see the Exercise arm description above.
|
Talk Therapy + Exercise (CBT+EXER)
n=34 participants at risk
Participants randomized to the combination therapy received both talk therapy and exercise as detailed above.
Program ACTIVE: Please see the Talk Therapy + Exercise arm description above.
|
Usual Care (UC)
n=36 participants at risk
Participants randomized to usual care received no study intervention.
Usual Care - No intervention: Please see the Usual Care arm description above.
|
|---|---|---|---|---|
|
General disorders
Adverse Event - Anticipated
|
8.3%
3/36 • Number of events 3
|
35.3%
12/34 • Number of events 12
|
32.4%
11/34 • Number of events 11
|
25.0%
9/36 • Number of events 9
|
|
Cardiac disorders
Adverse Event - Unanticipated
|
0.00%
0/36
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/36
|
Additional Information
Dr. Mary de Groot
Indiana University School of Medicine
Phone: 317-278-1965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place