DepressionCBT+SCTNCT03954392

CBT Enhanced With Social Cognitive Training

A study testing Cognitive behavior therapy with social cognitive training (CBT+SCT) and CBT-only in people with Depression, run by Vanderbilt University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Depression
What is being tested?: Cognitive behavior therapy with social cognitive training (CBT+SCT) and CBT-only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesUnited States
Study dates: 11 Feb 2019to 30 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Judy Garber
Nashville, Tennessee, 37203
Vanderbilt University
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: 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).

Read the 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,

Conditions: Depression
Being tested: Cognitive behavior therapy with social cognitive training (CBT+SCT), CBT-only
Keywords: Depression, Adolescents, Treatment
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive behavior therapy with social cognitive training (CBT+SCT)Behavioural
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-onlyBehavioural
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.

Study groups in NCT03954392
Study group	Role	What they receive
CBT+SCT	Experimental	Cognitive behavioral therapy plus social cognitive skills training (SCT) Receives: Behavioral: Cognitive behavior therapy with social cognitive training (CBT+SCT)
CBT-only	Active comparator	Cognitive behavioral therapy only (without SCT) Receives: Behavioral: CBT-only

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: week 12

Secondary outcomes (1)

Children Depression Rating Scale - Revised
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.
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 201930 Sep 2021

First posted17 May 2019
Study start11 Feb 2019
Primary completion31 Aug 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03954392
Sponsor's protocol ID: R61MH115125
Other IDs: 1R61MH115125-01A1
Acronym: CBT+SCT
Status last verified: Feb 2023
First submitted: 15 May 2019
Last updated: 28 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Social Cognitive Training to Enhance the Efficacy of CBT for Depression in Youth: A Developmental Approach
ClinicalTrials.gov ID: NCT03954392
Acronym / sponsor ID: CBT+SCT / R61MH115125
Conditions: Depression
Keywords: Depression, Adolescents, Treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 11 Feb 2019 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 17 May 2019 (actual)
Results: Posted 28 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
CBT+SCT	Experimental	Behavioral: Cognitive behavior therapy with social cognitive training (CBT+SCT)Cognitive behavioral therapy plus social cognitive skills training (SCT)
CBT-only	Active comparator	Behavioral: CBT-onlyCognitive behavioral therapy only (without SCT)

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	CBT+SCT
CBT-onlyThe 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.	Behavioural	CBT-only

Primary outcome

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.

1 secondary outcome

Children Depression Rating Scale - Revised
Time frame: week 12

Results and safety

Results posted to the registry on 28 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT+SCT	23	23
CBT-only	22	22

Primary outcome: Faux Pas Recognition Test

Time frame: week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	CBT+SCT n = 23	CBT-only n = 22
Value	0.901 (0.059)	0.854 (0.071)

CBT+SCT vs CBT-only: p < 0.05, ANCOVA

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The period of time over which adverse event data were collected was baseline to 2.5 years. For each participant, the time frame was baseline through their study completion (about 14 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT+SCT	0 of 23 (0%)	0 of 23 (0%)	0 of 23
CBT-only	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judy Garber, PhD principal investigator

Vanderbilt University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavior therapy with social cognitive training (CBT+SCT) and CBT-only in people with Depression, run by Vanderbilt University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Faux Pas Recognition Test (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03954392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.