Trial Outcomes & Findings for A Pychoeducational Intervention for Women With Diabetes (NCT NCT01185561)
NCT ID: NCT01185561
Last Updated: 2016-12-14
Results Overview
The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
6 Months
Results posted on
2016-12-14
Participant Flow
Participants were recruited between March 2007 and November 2009
Eighty-four participants consented to participate in the study. Among these individuals, 10 (11.90%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they had a significant psychiatric history, had a history of alcohol or drug abuse, or were not depressed.
Participant milestones
| Measure |
Usual Medical Care
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
Psychoeducational Intervention
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
38
|
|
Overall Study
COMPLETED
|
34
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
Reasons for withdrawal
| Measure |
Usual Medical Care
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
Psychoeducational Intervention
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
Baseline Characteristics
A Pychoeducational Intervention for Women With Diabetes
Baseline characteristics by cohort
| Measure |
Psychoeducational Intervention
n=38 Participants
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=36 Participants
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight
|
229.1 pounds (lbs)
STANDARD_DEVIATION 64.4 • n=5 Participants
|
226.9 pounds (lbs)
STANDARD_DEVIATION 48.7 • n=7 Participants
|
228.0 pounds (lbs)
STANDARD_DEVIATION 56.9 • n=5 Participants
|
|
Years Living with Diabetes
|
10.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
CES-D
|
27.7 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 9.5 • n=7 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
STAI Trait Anxiety Subtest
|
51.6 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
50.4 units on a scale
STANDARD_DEVIATION 9.2 • n=7 Participants
|
51.0 units on a scale
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
STAI State Anxiety Subtest
|
45.8 units on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
47.9 units on a scale
STANDARD_DEVIATION 11.9 • n=7 Participants
|
46.8 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
STAXI Anger Expression Subtest
|
40.6 units on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
34.7 units on a scale
STANDARD_DEVIATION 13.9 • n=7 Participants
|
37.7 units on a scale
STANDARD_DEVIATION 13.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: This analysis is restricted to participants who completed the final study visit six months after randomization.
The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.
Outcome measures
| Measure |
Psychoeducational Intervention
n=26 Participants
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=34 Participants
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression (CES-D) Score
|
12.6 units on a scale
Standard Deviation 8.0
|
21.5 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: This analysis is restricted to participants who completed the final study visit six months after randomization.
Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.
Outcome measures
| Measure |
Psychoeducational Intervention
n=26 Participants
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=34 Participants
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score
|
35.7 units on a scale
Standard Deviation 12.4
|
43.6 units on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: This analysis is restricted to participants who completed the final study visit six months after randomization.
Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.
Outcome measures
| Measure |
Psychoeducational Intervention
n=26 Participants
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=34 Participants
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score
|
36.9 units on a scale
Standard Deviation 10.1
|
45.3 units on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: This analysis is restricted to participants who completed the final study visit six months after randomization.
Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.
Outcome measures
| Measure |
Psychoeducational Intervention
n=26 Participants
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=34 Participants
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score
|
28.9 units on a scale
Standard Deviation 13.7
|
29.6 units on a scale
Standard Deviation 14.9
|
Adverse Events
Psychoeducational Intervention
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Usual Medical Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Psychoeducational Intervention
n=38 participants at risk
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=36 participants at risk
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
Psychiatric disorders
Inpatient Hospitalization
|
2.6%
1/38 • Number of events 1 • Adverse data were collected for 2 years, 8 months
|
0.00%
0/36 • Adverse data were collected for 2 years, 8 months
|
Other adverse events
| Measure |
Psychoeducational Intervention
n=38 participants at risk
Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes
Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
|
Usual Medical Care
n=36 participants at risk
Participants assigned to this arm represent the control group and will receive usual medical care only.
|
|---|---|---|
|
Psychiatric disorders
Worsening mood
|
5.3%
2/38 • Number of events 2 • Adverse data were collected for 2 years, 8 months
|
0.00%
0/36 • Adverse data were collected for 2 years, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place