Trial Outcomes & Findings for CBT Enhanced With Social Cognitive Training (NCT NCT03954392)
NCT ID: NCT03954392
Last Updated: 2023-03-28
Results Overview
The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character.
COMPLETED
NA
45 participants
week 12
2023-03-28
Participant Flow
Recruitment was primarily through a university listserv
Participants were randomized to condition shortly after eligibility was confirmed.
Participant milestones
| Measure |
CBT+SCT
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
|
CBT-only
Cognitive behavioral therapy only (without SCT)
CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CBT Enhanced With Social Cognitive Training
Baseline characteristics by cohort
| Measure |
CBT+SCT
n=23 Participants
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
|
CBT-only
n=22 Participants
Cognitive behavioral therapy only (without SCT)
CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
14.87 years
STANDARD_DEVIATION 1.49 • n=99 Participants
|
14.82 years
STANDARD_DEVIATION 1.62 • n=107 Participants
|
14.845 years
STANDARD_DEVIATION 1.545 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Faux Pas Recognition Test
|
0.853 units on a scale
STANDARD_DEVIATION 0.083 • n=99 Participants
|
0.851 units on a scale
STANDARD_DEVIATION 0.072 • n=107 Participants
|
0.852 units on a scale
STANDARD_DEVIATION 0.077 • n=206 Participants
|
|
Children's Depression Rating Scale
|
48.26 units on a scale
STANDARD_DEVIATION 5.66 • n=99 Participants
|
48.77 units on a scale
STANDARD_DEVIATION 6.32 • n=107 Participants
|
48.52 units on a scale
STANDARD_DEVIATION 5.98 • n=206 Participants
|
PRIMARY outcome
Timeframe: week 12Population: Participants were 45 youth (64% female), ages 12 through 17 years old (Mean = 14.84, S.D. = 1.54). Youth either met diagnostic criteria for a major depressive episode or persistent depressive disorder or a score of 35 or greater on the Children's Depression Rating Scale.
The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character.
Outcome measures
| Measure |
CBT+SCT
n=23 Participants
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
|
CBT-only
n=22 Participants
Cognitive behavioral therapy only (without SCT)
CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
|
|---|---|---|
|
Faux Pas Recognition Test
|
0.901 score on a scale
Standard Deviation 0.059
|
0.854 score on a scale
Standard Deviation 0.071
|
SECONDARY outcome
Timeframe: week 12Population: Study participants
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression). The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. Scores above 35 are considered to represent clinically significant symptoms. We measured depressive symptoms with the CDRS-R as a secondary outcome.
Outcome measures
| Measure |
CBT+SCT
n=23 Participants
Cognitive behavioral therapy plus social cognitive skills training (SCT)
Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
|
CBT-only
n=22 Participants
Cognitive behavioral therapy only (without SCT)
CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
|
|---|---|---|
|
Children Depression Rating Scale - Revised
|
23.74 score on a scale
Standard Deviation 5.59
|
34.59 score on a scale
Standard Deviation 10.60
|
Adverse Events
CBT+SCT
CBT-only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Judy Garber, Ph.D., Professor of Psychology and Human Development
Vanderbilt University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place