Cognitive Behavioral Therapy for Adolescent Depression

(LEADS Trial)

Overseen By Rachel A Vaughn-Coaxum, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Psychotic, Autism, Neurological, Substance, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how young teens can learn and remember a Cognitive Behavioral Therapy (CBT) skill called "cognitive restructuring," which helps change negative thought patterns. It focuses on adolescents aged 12 to 15 with high levels of depression who have faced challenging situations. The study aims to determine how these experiences affect their ability to learn and consistently use the CBT skill over six months. Teens who often feel very low or sad and have encountered tough times might be suitable for this trial. As an unphased study, this trial offers a unique opportunity for teens to gain valuable skills that could enhance their mental well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Cognitive Behavioral Therapy is safe for adolescents?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for treating depression in teenagers. Studies have found that CBT reduces depression and suicidal thoughts in teens. Only a small number of teens remain depressed after completing CBT, indicating that most tolerate the treatment well.

CBT teaches skills to manage thoughts and behaviors, helping young people change negative thinking and improve their mood. As CBT is not a medication, no serious side effects have been reported, making it a good option for many teens.

Overall, CBT is considered a safe and effective way to treat depression in adolescents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for adolescent depression, like antidepressant medications and traditional talk therapy, focus on altering brain chemistry or exploring feelings. But Cognitive Behavioral Therapy (CBT), specifically the "FIRST: Repairing Thoughts" approach, works differently. This treatment targets the underlying thought patterns that contribute to depression, teaching adolescents to recognize and change negative thinking. Researchers are excited about this method because it empowers young people to actively manage their depression by transforming their mindset, potentially leading to long-lasting improvements without the side effects associated with medication.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for adolescent depression?

Studies have shown that Cognitive Behavioral Therapy (CBT), which participants in this trial will receive as "FIRST: Repairing Thoughts," effectively treats depression. A review of 115 studies found that CBT strongly addresses depression by changing negative thought patterns. Research focusing on teenagers found that CBT can greatly reduce depression symptoms and even lower the risk of self-harm. Although the overall impact is moderate, CBT remains a valuable tool for managing depression in young people. ^{2 3 6 7 8}

Who Is on the Research Team?

Rachel A Vaughn-Coaxum, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for young adolescents aged 12-15 with symptoms of depression and a history of adverse childhood experiences. They must have a certain level of depression based on specific questionnaires but can't join if they have psychotic disorders, autism, substance abuse issues, ADHD, neurological conditions or are currently using stimulants.

Inclusion Criteria

I am between 12 and 15 years old.

I have been diagnosed with severe depression.

Exclusion Criteria

I have a long-term neurological or serious health condition.

I have been diagnosed with ADHD according to DSM 5.

Current DSM-5 diagnosis of substance abuse or dependence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (phone)

Baseline Assessment

Baseline assessment including diagnostic interviews and various psychological and cognitive tests

1 day

1 visit (in-person)

Experimental Skill Learning

Participants undergo a skill learning session for cognitive restructuring, including a follow-up session for practice and assessment

2-4 weeks

2 visits (in-person)

Skill Retention Assessment

Participants complete online surveys and phone interviews to assess skill retention at multiple follow-up points

6 months

3 follow-ups (online and phone)

What Are the Treatments Tested in This Trial?

Interventions

• FIRST: Repairing Thoughts

Trial Overview The study tests how well these adolescents can learn and retain 'cognitive restructuring' skills from Cognitive Behavioral Therapy (CBT) over six months. It looks at how past adversity affects their ability to control thoughts during learning and the impact on acquiring this skill.

How Is the Trial Designed?

Group I: FIRST: Repairing Thoughts Experimental Treatment 1 Intervention

FIRST: Repairing Thoughts is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Depression
• Anxiety

Approved in European Union as Cognitive Behavioural Therapy for:

• Depression
• Anxiety

Approved in Canada as Cognitive Behavioral Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) has been shown to be more effective than no treatment or waiting-list controls for school-age children with elevated depressive symptoms, indicating its efficacy in school settings.

For adolescents with diagnosed depressive disorders, CBT is also more effective than waiting-list conditions or non-CBT therapies during acute treatment, leading to faster symptom remission, although no single type of CBT has proven superior in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific psychotherapies for childhood and adolescent depression. Curry, JF.[2019]

Depression is a prevalent issue among adolescents, with psychiatric diagnoses found in 38% of those visiting primary care, making it crucial for physicians to recognize and address this condition.

Cognitive-behavioral therapy (CBT) is an effective treatment for adolescent depression, enhancing skills like self-control and problem-solving, and can be successfully implemented in primary care settings despite initial challenges in teaching the techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping depressed adolescents: a menu of cognitive-behavioral procedures for primary care. Clabby, JF.[2020]

Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for major depressive disorders in adolescents, with a meta-analysis revealing an overall effect size of 1.27 and 63% of patients experiencing clinically significant improvement after treatment.

The article aims to summarize various psychosocial interventions for depressed adolescents, making it easier for clinicians to access and utilize these resources in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial treatments for adolescent depression. Lewinsohn, PM., Clarke, GN.[2019]

In a study of 107 adolescents with major depressive disorder, no significant long-term differences were found in outcomes among cognitive behavioral therapy, systemic behavioral family therapy, and nondirective supportive therapy, indicating that all three therapies are similarly effective in the long run.

Most participants (80%) recovered from depression within a median of 8.2 months, but those with more severe initial depression and reported parent-child conflict were at higher risk for chronic depression and recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome after short-term psychotherapy for adolescents with major depressive disorder. Birmaher, B., Brent, DA., Kolko, D., et al.[2022]

Recent reviews indicate that cognitive behavioral therapy (CBT) for youth depression may have more modest effects than previously thought, suggesting a need to enhance its effectiveness.

Behavioral approaches within CBT have shown equal or even greater effectiveness compared to cognitive approaches for young people, indicating that these methods may be more suitable for treating youth depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back to basics: could behavioural therapy be a good treatment option for youth depression? A critical review. Hetrick, SE., Cox, GR., Fisher, CA., et al.[2022]

Cognitive-behavioral therapy (CBT) is highly effective for treating depression in children and adolescents, showing symptom reduction within 3 months and maintaining improvements for up to 2 years by addressing cognitive distortions and enhancing coping strategies.

While psychopharmacological treatments can be moderately effective, they require careful monitoring for potential adverse effects, such as suicidal behavior and agitation, highlighting the importance of safety in treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child & adolescent depression: review of the latest evidence-based treatments. Hamrin, V., Pachler, MC.[2022]

Cognitive-behavioral therapy (CBT) showed effectiveness in treating adolescents with depressive disorders in a clinical setting, with effect sizes ranging from small to large (Cohen's d = 0.33 to 0.82) based on assessments of 331 participants aged 11-18.

Despite the positive outcomes, a significant number of adolescents remained in the clinical range for depression after treatment, indicating that while CBT is beneficial, it may not be sufficient for all individuals and further support may be needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of usual-care cognitive-behavioral therapy for adolescents with depressive disorders rated by parents and patients - an observational study. Walter, D., Buschsieweke, J., Dachs, L., et al.[2021]

This study aims to evaluate the effectiveness of four core components of Cognitive Behavioural Therapy (CBT) in preventing depression among high school students with elevated depressive symptoms, using a non-blinded multisite cluster randomized microtrial design.

By comparing different sequences of these CBT components, the research seeks to identify which combinations are most effective and for whom, potentially leading to more personalized and optimized CBT programs for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling the relative effectiveness of core components of cognitive behavioural therapy in preventing depression in adolescents: protocol of a cluster randomized microtrial. van den Heuvel, MWH., Bodden, DHM., Moerbeek, M., et al.[2020]

Cognitive-behavioral therapy (CBT) effectively addresses mental disorders by helping individuals replace negative beliefs with more adaptive thoughts, using techniques like Cognitive Restructuring and Problem-Solving to empower patients.

CBT techniques, such as Affect Regulation, are particularly beneficial for adolescents, teaching them to manage negative emotions and improve their problem-solving skills, which can reduce the risk of crises like suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall goal of Cognitive-Behavioral Therapy in Major Psychiatric Disorders and Suicidality: A Narrative Review. Serafini, G., Costanza, A., Aguglia, A., et al.[2022]

Cognitive-behavioral therapy (CBT) is recognized as an effective treatment for depression in children and adolescents, but there is limited evidence specifically addressing its efficacy for adolescents experiencing suicidality.

The article discusses various CBT techniques aimed at reducing suicidal thoughts and behaviors in depressed adolescents, highlighting the need for more targeted treatment trials in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. Spirito, A., Esposito-Smythers, C., Wolff, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5441981/

Developmental Demands of Cognitive Behavioral Therapy for ... Psychotherapies also have been shown to successfully reduce depression in children and adolescents, although the overall effect size has been modest (ES=.34; ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7001356/

Cognitive Behavioral Therapy for Depression - PMC A meta-analysis of 115 studies has shown that CBT is an effective treatment strategy for depression and combined treatment with pharmacotherapy is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724000991

Elucidating the process-based emphasis in cognitive ... Component studies comparing cognitive restructuring with behavioral strategies often yield mixed results, with little conclusive evidence that cognitive ...

4. mdpi.com mdpi.com/1660-4601/18/9/4600

Psychological Treatments for Depression in Adolescents Median recovery time was 22.6 weeks for CBT plus TAU and 30 weeks for TAU alone. Compared with TAU alone, the reduction in clinician-rated and adolescent- ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1672957/full

The efficacy of cognitive behavioral therapy on reducing ... CBT significantly reduced the risk of suicidal and self-harming behaviors across all follow-up durations (short-term OR = 0.72, 95% CI: 0.53 to 0.97; mid-term ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3073681/

Cognitive-behavioral therapy for adolescent depression ... Overall, results have shown that CBT for depression in adolescents is effective in reducing suicidality. In general, these programs teach coping skills and ...

7. medicine.umich.edu medicine.umich.edu/sites/default/files/content/downloads/Behavioral-Activation-for-Depression.pdf

Behavioral activation is one of the most important CBT ... Behavioral activation is one of the most important CBT skills used in treating depression. It has to do with the way that behaviors and feelings influence each ...

8. 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.