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

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to assess acquisition and retention of a Cognitive Behavioral Therapy (CBT)-based "cognitive restructuring" skill, among young adolescents (12-15 years of age) with elevated depression symptoms and with population-level variability in lifetime exposure to adverse childhood experiences. This study uses a repeated-measures, longitudinal design to investigate associations between adversity exposure and learning-related cognitive control processes in the context of elevated depression (Aim 1). Adversity exposure and cognitive control will be examined as direct predictors of cognitive restructuring skill acquisition and skill retention over six-months; an indirect pathway from adversity to skill acquisition through cognitive control will also be examined (Aim 2). The study also includes exploration of key characteristics of adversity, namely the type (threat of harm versus deprivation of resources) and developmental timing of exposure, as distinct predictors of skill acquisition (exploratory Aim 3).

Will I have to stop taking my current medications?

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

Is Cognitive Behavioral Therapy (CBT) safe for adolescents?

Cognitive Behavioral Therapy (CBT) is generally considered safe for adolescents, as it focuses on changing negative thought patterns and behaviors without the use of medication. It has been widely used and studied for various mental health conditions, including depression, with no significant safety concerns reported. ^{1 2 3 4 5}

How is the treatment 'Cognitive Behavioral Therapy for Adolescent Depression' unique compared to other treatments?

Cognitive Behavioral Therapy (CBT) for adolescent depression is unique because it focuses on changing negative thought patterns and teaching problem-solving and coping strategies, which can lead to significant improvement in symptoms within a short period and maintain these gains over time. Unlike some other treatments, CBT does not involve medication, making it a non-drug option that enhances self-control and social skills. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Adolescent Depression?

Research shows that Cognitive Behavioral Therapy (CBT) is effective for treating adolescent depression, with studies indicating that 63% of patients show significant improvement. CBT helps adolescents develop better self-control, problem-solving, and social skills, leading to more rapid symptom relief compared to other therapies. ^{1 2 8 9 10}

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Specific psychotherapies for childhood and adolescent depression. [2019]

2. England 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Psychosocial treatments for adolescent depression. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical outcome after short-term psychotherapy for adolescents with major depressive disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Overall goal of Cognitive-Behavioral Therapy in Major Psychiatric Disorders and Suicidality: A Narrative Review. [2022]

7. England 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. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Back to basics: could behavioural therapy be a good treatment option for youth depression? A critical review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Child & adolescent depression: review of the latest evidence-based treatments. [2022]