Trial Outcomes & Findings for Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes (NCT NCT04214600)
NCT ID: NCT04214600
Last Updated: 2020-11-27
Results Overview
Assess the effect of the CBT combined with diabetes education versus control receiving diabetes education alone on glycemic measures of patients with T2D and depression
COMPLETED
NA
100 participants
Baseline and 3 months
2020-11-27
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy
This group will receive four CBT sessions twice a month for two months
Cognitive Behavioral Therapy (CBT): Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:
Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills
|
Control
This group will be scheduled the same number of visits as a follow up for diabetes
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy
This group will receive four CBT sessions twice a month for two months
Cognitive Behavioral Therapy (CBT): Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:
Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills
|
Control
This group will be scheduled the same number of visits as a follow up for diabetes
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
14
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy
n=50 Participants
This group will receive four CBT sessions twice a month for two months
Cognitive Behavioral Therapy (CBT): Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician and will include:
Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills
|
Control
n=50 Participants
This group will be scheduled the same number of visits as a follow up for diabetes.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age interval · 35-44
|
5 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
17 Participants
n=100 Participants
|
|
Age, Customized
Age interval · 45-54
|
19 Participants
n=50 Participants
|
18 Participants
n=50 Participants
|
37 Participants
n=100 Participants
|
|
Age, Customized
Age interval · 45-64
|
11 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
17 Participants
n=100 Participants
|
|
Age, Customized
Age interval · ≥65
|
15 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
29 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=50 Participants
|
35 Participants
n=50 Participants
|
69 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post-intervention assessment.
Assess the effect of the CBT combined with diabetes education versus control receiving diabetes education alone on glycemic measures of patients with T2D and depression
Outcome measures
| Measure |
CBT Group
n=41 Participants
Participants received four Cognitive Behavioral Therapy sessions and diabetes education
|
Control Group
n=36 Participants
Participants received diabetes education only
|
|---|---|---|
|
Change of Glycated Hemoglobin A1c (Hb A1c) After the Cognitive Behavioral Therapy Sessions
|
7.70 percent
Standard Error 0.23
|
8.42 percent
Standard Error 0.25
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Of the 100 patients that met the inclusion criteria and completed the baseline assessment, only 77 patients completed the post intervention assessment.
Assess the effect of the CBT combined with diabetes education versus control receiving diabetes education alone on depressive symptoms of patients with T2D and depression (Beck's Depression Index scores range between 1-40 where high scores mean worsening outcome and low scores mean improving outcome)
Outcome measures
| Measure |
CBT Group
n=41 Participants
Participants received four Cognitive Behavioral Therapy sessions and diabetes education
|
Control Group
n=36 Participants
Participants received diabetes education only
|
|---|---|---|
|
Change of Depression Score on Beck's Depression Index
|
12.25 score on a scale
Standard Error 1.09
|
16.49 score on a scale
Standard Error 1.16
|
Adverse Events
CBT Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place