- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954392
CBT Enhanced With Social Cognitive Training (CBT+SCT)
February 28, 2023 updated by: Judith Garber, Vanderbilt University
Social Cognitive Training to Enhance the Efficacy of CBT for Depression in Youth: A Developmental Approach
Depression in youth is a serious public health concern for which more personalized treatments are needed.
This study will test the effect of an intervention aimed at enhancing depressed children's social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective.
Participants in both the R61 (N=42) and R33 (N=82) will be youth between 12 and 17 years old currently experiencing a depressive disorder.
Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind as compared to CBT only.
The primary target is improvement in the social cognitive skills at post treatment in the first trial (R61) and improvements in both social cognitive skills and depressive symptoms at post-treatment and at a 4-month follow-up (R33).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Depression in youth is a recurrent and impairing disorder.
Although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy -- CBT), there remains a critical need to build upon these therapies in order to reach even more youths with depression.
One variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and CBT (e.g., social perspective taking; theory of mind).
The first RCT (R61) will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities.Youth (ages 12-17; N=42) with depression diagnoses or clinical levels of depressive symptoms (CESD > 20) will be randomized to either the social cognitive training enhanced CBT (SCT-CBT) or CBT only.
Pre- and post-treatment evaluations will assess the social cognitions.
In the second RCT (R33), we will conduct a replication trial with a new sample of 82 youth (ages 12-17) again randomized to SCT-CBT or CBT only.
Youth will be evaluated with regard to the SC abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 4-month follow-up (R33).
Finally, in the R33 we will test if increases in SC abilities partially account for the relation between treatment condition and decreases in depression.
If the SCT-CBT intervention significantly improves children's SC abilities and social functioning and decreases depression, then this will provide therapists with a more efficient and personalized treatment of depression in youth,
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University
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Nashville, Tennessee, United States, 37203
- Judy Garber
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 12- to 17-years-old
- diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Children's Depression Rating Scale (CDRS) >= 40
Exclusion Criteria:
- ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder
- current alcohol or substance use disorder with significant impairment
- imminent risk of suicide
- reading level < 4th grade
- estimated IQ<80
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT+SCT
Cognitive behavioral therapy plus social cognitive skills training (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.
|
Active Comparator: CBT-only
Cognitive behavioral therapy only (without SCT)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Faux Pas Recognition Test
Time Frame: week 12
|
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.
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children Depression Rating Scale - Revised
Time Frame: week 12
|
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.
|
week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire 9 (PHQ9)
Time Frame: week 12
|
Self-report measure of the 9 main depressive symptoms that define a depressive episode
|
week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R61MH115125 (U.S. NIH Grant/Contract)
- 1R61MH115125-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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