CBT Enhanced With Social Cognitive Training

NCT03954392 | Completed Results DMC

• 2 other identifiers: R61MH1151251R61MH115125-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Depression

Keywords

Depression; Adolescents; Treatment

Outcome Measures

Primary Outcomes (1)

• Faux Pas Recognition Test

  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 Outcomes (1)

• Children Depression Rating Scale - Revised

  week 12

Study Arms (2)

CBT+SCT

EXPERIMENTAL

Cognitive behavioral therapy plus social cognitive skills training (SCT)

Behavioral: Cognitive behavior therapy with social cognitive training (CBT+SCT)

CBT-only

ACTIVE COMPARATOR

Cognitive behavioral therapy only (without SCT)

Behavioral: CBT-only

Interventions

Cognitive behavior therapy with social cognitive training (CBT+SCT) BEHAVIORAL

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+SCT

CBT-only BEHAVIORAL

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.

CBT-only

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Judy Garber

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

COVID19 started during the trial. We were able to move to conducting the study remotely (e.g., Zoom). That is, assessments and therapy sessions were conducted on Zoom. Overall, moving to remote methods was not a problem and allowed us to continue the trial without disruption.

Results Point of Contact

• Title: Judy Garber, Ph.D., Professor of Psychology and Human Development
• Organization: Vanderbilt University

judy.garber@vanderbilt.edu; jgarber.vanderbilt@gmail.com

16153305605

Study Officials

• Judy Garber, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study has two intervention arms: (1) CBT + SCT is cognitive behavioral therapy enhanced with training in social cognitive abilities (e.g., social perspective taking), and (2) CBT-only is cognitive behavioral therapy without the additional SCT training component. Adolescents are randomized to either condition. We will stratify randomization by gender, age (12-14; 15-17), race/ethnicity (minority status), and medication use.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: February 11, 2019
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)