Enhanced CBT for Depression

Overseen By Steven D Hollon, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Bipolar, Schizophrenia, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating depression in teens aged 13-17 by enhancing social cognitive skills, such as understanding others' perspectives. Participants will be randomly assigned to receive either traditional cognitive behavioral therapy (CBT) or CBT with additional training in social skills (CBTSCT, Cognitive Behavioral Therapy with Social Cognitive Training). The main goal is to determine if the enhanced therapy leads to better social skills and reduced depression symptoms, both immediately after treatment and six months later. Teens currently experiencing depression and interested in developing better social understanding might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for teens to explore innovative treatments that could improve their social skills and mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced CBT intervention is safe for treating depression in youth?

Research has shown that combining social skills training with traditional therapy, such as Cognitive Behavioral Therapy (CBT), can be beneficial. In this approach, participants learn social skills alongside standard CBT techniques.

CBT is a well-known therapy for managing depression, helping individuals change negative thoughts and behaviors. Studies indicate that CBT is generally safe and well-tolerated, with few side effects.

Adding social skills training aims to improve how individuals understand and interpret social situations, potentially enhancing CBT's effectiveness. Although detailed safety data for this new combined approach (CBTSCT) is not yet available, the main components, like CBT, have a strong safety record. This suggests that the enhanced version is likely safe for most participants, similar to regular CBT. Participants should remain aware of any personal discomfort and communicate openly with their therapists. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced CBT for Depression because it combines cognitive behavioral therapy (CBT) with social cognitive training (SCT). This unique approach not only addresses the negative thought patterns typical of depression, as standard CBT does, but also improves social skills by teaching teens theory of mind and perspective taking. These additional skills can help adolescents navigate social situations more effectively, potentially leading to better overall outcomes. By integrating these elements, Enhanced CBT holds promise for offering a more comprehensive treatment for depression in teens than traditional CBT alone.

What evidence suggests that CBTSCT could be an effective treatment for depression?

Research shows that combining social skills training with traditional therapy can significantly enhance emotional understanding and reduce depression symptoms. This trial will compare two approaches: Cognitive Behavioral Therapy (CBT) and an enhanced version of CBT that includes social skills training (CBTSCT). Studies have extensively examined CBT and recommend it for treating depression, as it effectively improves skills like assertiveness and coping in various situations. The enhanced version, CBTSCT, aims to improve abilities like understanding others' perspectives, potentially making treatment more effective for young people with depression. Initial findings suggest that this approach could lead to better social interactions and reduced depression. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for young people aged 13-17 who are currently dealing with depression. They must have been diagnosed with a depressive disorder or score over 15 on the PHQ9 questionnaire. It's not open to those at immediate risk of suicide, below a 4th-grade reading level, struggling with severe substance abuse, or previously diagnosed with bipolar, schizophrenia, autism, or conduct disorder.

Inclusion Criteria

I am between 13 and 17 years old.

I am a young person diagnosed with depression or scored over 15 on the PHQ9.

Exclusion Criteria

Reading level < 4th grade

Ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder

Current alcohol or substance use disorder with significant impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT enhanced with social cognitive training or CBT only for 12 weeks

12 weeks

Weekly sessions

Follow-up

Participants are monitored for improvements in social cognitive skills and depressive symptoms

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CBTSCT

Trial Overview The study compares two methods: standard Cognitive Behavioral Therapy (CBT) and CBT enhanced with Social Cognitive Training (CBTSCT), which focuses on improving social understanding like perspective-taking. Participants will be randomly assigned to one of these treatments to see which is more effective in treating depression symptoms and social cognition.

How Is the Trial Designed?

Group I: Cognitive behavioral therapy plus social cognitive training (CBTSCT) Experimental Treatment 1 Intervention

The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy with depressed adolescents using modules from the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, therapists will teach teens explicitly about theory of mind and social perspective taking during each session and will use examples from the teen's own life to help them learn the skills.

Group II: Cognitive behavioral therapy (CBT) Active Control 1 Intervention

The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. Therapists will conduct individual therapy sessions with depressed adolescents using modules from the Coping with Stress manual. Social cognitive training will not be provided to teens in this condition.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive therapy (CT) for depression shows a strong link between changes in cognitive patterns and improvements in depressive symptoms, highlighting the importance of addressing thought processes in treatment.

The review suggests that both specific techniques used in CT and the therapeutic environment play significant roles in treatment outcomes, indicating that personalizing therapy to client characteristics may enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators and moderators of change in cognitive therapy of depression. Whisman, MA.[2019]

Social-cognitive training (SCT) has moderate positive effects on emotion recognition, mental state attribution, and social perception in individuals with schizophrenia, based on a meta-analysis of 42 controlled trials involving 1,868 participants.

However, SCT did not significantly improve psychiatric symptoms or social functioning, indicating that while it enhances certain social-cognitive skills, further research is needed to extend these benefits to broader clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effects of social-cognitive training in schizophrenia: The role of treatment characteristics and study quality. Yeo, H., Yoon, S., Lee, J., et al.[2022]

Cognitive Behavioral Therapy (CBT) is effective for treating Social Phobia (SP), with effect sizes ranging from 0.6 to 2.6, indicating a significant positive impact on patients' symptoms.

Despite its effectiveness, there is still considerable room for improvement in CBT approaches for SP, and the review suggests exploring new and promising directions to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social phobia: maintenance models and main components of CBT. Marom, S., Aderka, IM., Hermesh, H., et al.[2022]

In a study involving 182 adult outpatients with major depression, both interpersonal psychotherapy (IPT) and cognitive therapy (CT) were found to be more effective than a waitlist control, with no significant differences in outcomes between the two therapies over a follow-up period of up to 17 months.

The study suggests that while IPT and CT are similarly effective, the mechanisms through which they produce change may differ, indicating a need for more personalized treatment approaches to identify which therapy may be more beneficial for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal Psychotherapy Versus Cognitive Therapy for Depression: How They Work, How Long, and for Whom-Key Findings From an RCT. Lemmens, LHJM., van Bronswijk, SC., Peeters, FPML., et al.[2022]

In a study involving 523 outpatients undergoing 12-14 weeks of cognitive therapy (CT), improvements in patients' cognitive therapy skills were linked to reductions in depressive symptoms, suggesting that these skills play a crucial role in treatment efficacy.

The research indicates that while depressive symptoms did not influence the development of cognitive therapy skills, higher skill levels during treatment were associated with better outcomes, highlighting the importance of skill acquisition in managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' comprehension and skill usage as a putative mediator of change or an engaged target in cognitive therapy: Preliminary findings. Jarrett, RB., Vittengl, JR., Clark, LA., et al.[2020]

Social cognition and interaction training (SCIT) significantly improved emotion perception, theory of mind, and attributional styles in 30 first-episode patients with major depression compared to 29 patients receiving only standard treatment.

Patients who underwent SCIT also experienced a notable reduction in the severity of depressive symptoms, suggesting that SCIT is a promising addition to traditional treatment methods for enhancing social cognition in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social cognition and interaction training for major depression: A preliminary study. Zhu, S., Zhu, K., Jiang, D., et al.[2019]

Imagery-enhanced cognitive behavioural group therapy (IE-CBGT) for social anxiety disorder (SAD) was well-received by patients, showing high attendance and completion rates among the 19 participants in the study.

IE-CBGT demonstrated large to very large effect sizes in reducing performance and social interaction anxiety, suggesting it may be more effective than traditional CBGT, although further research with larger randomized controlled trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. McEvoy, PM., Saulsman, LM.[2019]

In a trial involving 174 adults with major depressive disorder, metacognitive therapy (MCT) showed significant improvement in self-reported depression symptoms compared to cognitive behavioral therapy (CBT), with a notable difference on the Beck Depression Inventory II (BDI-II) both immediately after treatment and at a six-month follow-up.

74% of patients receiving MCT met recovery criteria on the BDI-II post-treatment, compared to 52% in the CBT group, indicating that MCT may be a more effective treatment option for depression than traditional CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial. Callesen, P., Reeves, D., Heal, C., et al.[2021]

In a randomized controlled trial with 80 older adults suffering from major depressive disorder, both Metacognitive Training-Silver (MCT-Silver) and cognitive remediation showed significant reductions in depressive symptoms, but MCT-Silver did not outperform cognitive remediation on clinician-rated depression scores.

MCT-Silver was particularly effective in reducing self-reported depression and rumination, especially in patients with high baseline rumination and positive metacognitive beliefs, suggesting it may be beneficial for specific subgroups of older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and moderators of metacognitive training for depression in older adults (MCT-Silver): A randomized controlled trial. Schneider, BC., Veckenstedt, R., Karamatskos, E., et al.[2023]

Metacognitive therapy (MCT) was found to be an effective treatment for depression, showing similar efficacy to cognitive behavioral therapy (CBT) in a pilot study with 48 outpatient participants over 12 weeks.

Both therapies led to significant reductions in depressive symptoms, but MCT's effectiveness may have been impacted by higher levels of comorbidity among participants, suggesting that further research is needed to fully understand its comparative efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus cognitive behavioural therapy for depression: a randomized pilot study. Jordan, J., Carter, JD., McIntosh, VV., et al.[2018]

Metacognitive therapy (MCT) significantly reduced interpersonal problems in patients with depression, despite not directly targeting these issues, indicating its broad efficacy in treating depressive symptoms.

The study, which used a waitlist control design and assessed patients before and after treatment as well as at a 6-month follow-up, found that interpersonal problems did not negatively impact the treatment response to MCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive Therapy for Depression Reduces Interpersonal Problems: Results From a Randomized Controlled Trial. Strand, ER., Hagen, R., Hjemdal, O., et al.[2020]

Imagery-enhanced group cognitive behavior therapy (CBT) for social anxiety disorder (SAD) showed large within-group effect sizes (around 2.05 to 2.19) in both the original Australian clinic and an independent Canadian clinic, indicating its effectiveness in reducing social interaction anxiety.

However, the comparison between the two clinics revealed a very small and non-significant effect size (d=0.09), suggesting that while the therapy is effective within groups, the generalization of its effects across different settings and clinicians may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transportability of imagery-enhanced CBT for social anxiety disorder. McEvoy, PM., Erceg-Hurn, DM., Barber, KC., et al.[2019]

In a study of 117 depressed outpatients undergoing either Cognitive Therapy (CT) or Interpersonal Psychotherapy (IPT), CT was associated with a higher rate of sudden gains (42.2%) compared to IPT (24.5%), suggesting that CT may facilitate quicker improvements in symptoms.

Despite the differences in the occurrence of sudden gains, both therapies ultimately led to similar outcomes in terms of overall depression severity, indicating that both CT and IPT are effective treatments for depression, potentially through different mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden gains in Cognitive Therapy and Interpersonal Psychotherapy for adult depression. Lemmens, LH., DeRubeis, RJ., Arntz, A., et al.[2018]

In a randomized clinical trial with 86 young adults, both individual Trial-Based Cognitive Therapy (TBCT) and group Cognitive-Behavioral Therapy (Group CBT) significantly reduced symptoms of social anxiety and depression compared to a waitlist control group.

This study is the first to compare TBCT and Group CBT in Brazil, demonstrating that both interventions are effective in addressing social anxiety disorder and related psychiatric symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. Neufeld, CB., Palma, PC., Caetano, KAS., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05456035?locStr=United+States&country=United+States&aggFilters=status%3A

CBT Enhanced With Social Cognitive Training vs. ... Youth will be evaluated regarding their social cognitive abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... CBT was shown to be superior in the treatment of secondary symptoms of spinal cord injury as compared to controls in assertiveness skills, coping, depression ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05456035/cbt-enhanced-with-social-cognitive-training-vs-cbt-only-with-depressed-youth

CBT Enhanced With Social Cognitive Training vs. ... This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

Cognitive behavior therapy vs. control conditions, other ... Cognitive behavior therapy (CBT) is by far the most examined type of psychological treatment for depression and is recommended in most ...

5. withpower.com withpower.com/trial/phase-depression-7-2022-d660b

Enhanced CBT for Depression Research shows that combining social cognition training with traditional therapy can significantly improve emotional understanding and reduce depressive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... Within CBTs for depression specifically, a systematic review and meta-analysis showed that lower age, higher initial depression severity, individual treatment ...