Cognitive Behavioral Therapy for Adolescent Depression

(PATHway Trial)

Recruiting at 5 trial locations

Overseen By Rebecca T Feinstein, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antidepressants, Antianxiety, others

Disqualifiers: Psychotic, Bipolar, Hospitalizations, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to prevent depression in at-risk teenagers using the CATCH-IT program. The program teaches skills to manage thoughts, behaviors, and relationships through various therapies. The goal is to make the program effective, easy to use, and widely available. CATCH-IT is an online depression prevention intervention that has been tested in various studies for its effectiveness in preventing depressive episodes among adolescents.

Do I have to stop taking my current medications to join the trial?

Yes, you must stop taking any current medication therapy for depression, anxiety, or other internalizing disorders to participate in this trial.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current medication therapy for depression, anxiety, or other internalizing disorders to participate in this trial.

What data supports the idea that Cognitive Behavioral Therapy for Adolescent Depression (also known as: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training, CATCH-IT) is an effective treatment?

The available research shows that Cognitive Behavioral Therapy (CBT) helps adolescents recover from depression faster than other treatments. One study found that CBT led to quicker recovery times compared to a life skills-tutoring control group, especially for certain groups of adolescents. Another study reported significant decreases in depression symptoms after CBT sessions, with improvements lasting up to five months. Additionally, a review of multiple CBT studies estimated that 63% of patients showed significant improvement, suggesting that CBT is an effective treatment for adolescent depression. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CATCH-IT for adolescent depression?

Research shows that cognitive behavioral therapy (CBT), a component of CATCH-IT, is effective for treating adolescent depression, with studies indicating significant improvement in depressive symptoms and faster recovery times compared to control treatments. Additionally, a meta-analysis of CBT studies found that 63% of patients showed clinically significant improvement, suggesting that CBT is a promising intervention for depressed adolescents. ^{1 2 3 4 5}

What safety data exists for Cognitive Behavioral Therapy (CBT) in treating adolescent depression?

The research indicates that Cognitive Behavioral Therapy (CBT) is a suitable treatment for clinically depressed adolescents, showing significant reductions in affective diagnoses post-treatment and at six-month follow-up. However, CBT did not outperform Treatment As Usual (TAU) in clinical practice, suggesting both treatments are safe and effective. No significant differences in self-reported depressive symptoms were found between CBT and TAU, and no adverse safety concerns were reported. Further improvement in CBT is needed to decrease symptom levels below the clinical cut-off at post-treatment. ^{3 4 6 7 8}

Is Cognitive Behavioral Therapy (CBT) safe for adolescents with depression?

Cognitive Behavioral Therapy (CBT) has been studied in adolescents with depression and is generally considered safe. The research did not report any significant safety concerns, indicating that CBT is a suitable treatment option for clinically referred depressed adolescents. ^{3 4 6 7 8}

Is CATCH-IT a promising treatment for adolescent depression?

Yes, CATCH-IT is a promising treatment for adolescent depression. It is based on cognitive-behavioral therapy (CBT), which has been shown to be effective in helping many adolescents improve their depression symptoms. ^{5 9 10 11 12}

How is the CATCH-IT treatment different from other treatments for adolescent depression?

CATCH-IT is unique because it combines cognitive-behavioral therapy (CBT) with humanistic and interpersonal training, offering a comprehensive approach that addresses not only thoughts and behaviors but also personal growth and social relationships, which is not typically found in standard CBT or interpersonal therapy alone. ^{5 9 10 11 12}

Research Team

Benjamin W Van Voorhees, MD, MPH

Principal Investigator

UIC, College of Medicine

Tracy RG Gladstone, PhD

Principal Investigator

Wellesley College

Calvin Rusiewski, MBBS

Principal Investigator

UIC, College of Medicine

Eligibility Criteria

This trial is for adolescents aged 13-18 with mild to moderate depression symptoms (PHQ-9 score of 5-18), who may have had past depressive episodes but are not currently in one. Participants must speak English, be willing to follow the study protocol, and not be on medication or in therapy for mood disorders.

Inclusion Criteria

I am between 13 and 18 years old.

I am a teenager with mild to moderate depression.

I have had depression in the past but am not currently experiencing it.

Exclusion Criteria

As assessed by the MINI Kid, a current depressive episode

My child's guardian has a cognitive or intellectual impairment.

Any past psychiatric hospitalizations

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the CATCH-IT program, which includes various modules such as behavioral activation, cognitive-behavioral therapy, and interpersonal psychotherapy, tailored to optimize intervention efficacy, tolerability, and scalability.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of various psychological and behavioral outcomes.

12 months

Implementation Preparation

Preparation for implementation studies and dissemination, focusing on optimizing intervention components for scalability and acceptability.

Treatment Details

Interventions

• Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training

Trial Overview The PATHway Study tests a 'behavioral vaccine' called CATCH-IT designed to prevent depression. It's based in primary care and uses Cognitive-Behavioral, Humanistic, and Interpersonal Training. The study will optimize this intervention across several health systems before wider implementation.

Participant Groups

Group I: 9. Parent program modules only Experimental Treatment 1 Intervention

Parent program modules

Group II: 8. Full Adolescent program only Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules

Group III: 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules Experimental Treatment 1 Intervention

Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules

Group IV: 6. Adolescent behavioral activation modules + interpersonal therapy modules Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Adolescent interpersonal therapy modules

Group V: 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules

Group VI: 4. Adolescent interpersonal therapy modules only Experimental Treatment 1 Intervention

Adolescent interpersonal therapy modules only

Group VII: 3. Adolescent cognitive-behavioral therapy modules only Experimental Treatment 1 Intervention

Adolescent cognitive-behavioral therapy modules only

Group VIII: 2. Adolescent behavioral activation modules only Experimental Treatment 1 Intervention

Adolescent behavioral activation modules only

Group IX: 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules Experimental Treatment 1 Intervention

Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules

Group X: 14. Adolescent behavioral activation + interpersonal therapy + parent program modules Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules

Group XI: 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules

Group XII: 12. Adolescent interpersonal therapy modules + parent program modules Experimental Treatment 1 Intervention

Adolescent interpersonal therapy modules Parent Program

Group XIII: 11. Adolescent cognitive-behavioral therapy modules + parent program modules Experimental Treatment 1 Intervention

Adolescent cognitive-behavioral therapy modules Parent program modules

Group XIV: 10. Adolescent behavioral activation modules + parent program modules Experimental Treatment 1 Intervention

Adolescent behavioral activation modules Parent program modules

Group XV: 1. No adolescent modules + no parent modules Active Control 1 Intervention

No adolescent nor parent modules will be offered to the participant.

Group XVI: 16. All adolescent + parent program modules Active Control 1 Intervention

Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules

Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training is already approved in United States for the following indications:

Approved in United States as CATCH-IT for:

• Depression prevention in adolescents

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

Mile Square Health Center

Collaborator

Trials

2

Recruited

1,000+

Lawndale Christian Health Center

Collaborator

Trials

3

Recruited

1,200+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

NorthShore University HealthSystem

Collaborator

Trials

134

Recruited

740,000+

Advocate Health Care

Collaborator

Trials

57

Recruited

1,412,000+

Wellesley College

Collaborator

Trials

6

Recruited

3,100+

Findings from Research

In a study of 114 depressed adolescents from a juvenile justice center, factors such as earlier onset of major depressive disorder (MDD), attention-deficit/hyperactivity disorder, and low family cohesion were identified as predictors of recovery time over a 1-year follow-up.

Cognitive Behavioral Therapy (CBT) led to faster recovery compared to a life skills-tutoring control, particularly for White adolescents with recurrent MDD and good coping skills, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting time to recovery among depressed adolescents treated in two psychosocial group interventions. Rohde, P., Seeley, JR., Kaufman, NK., et al.[2019]

A 12-session open trial of cognitive therapy for depressed adolescents showed significant reductions in depressive symptoms, with effects lasting up to 5 months after treatment.

The therapy was less effective for adolescents with comorbid conditions like ADHD or schizoid personality disorder, indicating the need for further controlled trials to explore these variations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open, multisite pilot study of cognitive therapy for depressed adolescents. Belsher, G., Wilkes, TC., Rush, AJ.[2021]

Interpersonal psychotherapy for adolescents (IPT-A) was refined and standardized for a small group of 5 depressed adolescents, leading to a successful treatment approach tailored for their needs.

In a 12-week trial with 14 depressed adolescents, IPT-A significantly reduced depressive symptoms and improved overall functioning, with none of the participants meeting criteria for depression at the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of interpersonal psychotherapy with depressed adolescents (IPT-A): phase I and II studies. Mufson, L., Moreau, D., Weissman, MM., et al.[2006]

The family-based interpersonal psychotherapy (FB-IPT) showed high treatment compliance (88%) and led to significant reductions in depressive and anxiety symptoms among 16 preadolescents aged 9-12, indicating its feasibility and acceptability as a treatment option.

Preadolescents receiving FB-IPT alone experienced similar improvements in depressive symptoms and global functioning as those who also received antidepressant medication, suggesting that FB-IPT can be effective on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based interpersonal psychotherapy for depressed preadolescents: an open-treatment trial. Dietz, LJ., Mufson, L., Irvine, H., et al.[2021]

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 involving 88 clinically depressed adolescents, manualized cognitive behavioral therapy (CBT) did not show superior effectiveness compared to Treatment As Usual (TAU) in reducing depressive symptoms, with both treatments yielding similar outcomes.

At post-treatment, 41.6% of adolescents receiving CBT and 31.8% receiving TAU were below the clinical cut-off for depressive symptoms, indicating that while both treatments were effective, CBT needs further refinement to enhance its efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial. Stikkelbroek, Y., Vink, G., Nauta, MH., et al.[2021]

The 'Training for Awareness, Resilience and Action' (TARA) program is a novel group-treatment designed specifically for adolescents and young adults with depression, targeting mechanisms identified through neuroscientific research, and has shown preliminary efficacy in treating this age group.

This study will be the first randomized controlled trial (RCT) to compare TARA with standard treatments for major and persistent depressive disorders in patients aged 15-22, using a variety of outcome measures to comprehensively evaluate its effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial. Ekbäck, E., Granåsen, G., Svärling, R., et al.[2021]

Depression is a significant mental health issue in children and adolescents, and effective treatment options are necessary, with a review of 24 pharmacological and 11 psychological intervention studies highlighting the need for more randomized controlled trials.

Among the treatments, fluoxetine is notable as it is the only SSRI that does not increase suicidality compared to placebo, and combination therapies of SSRIs with cognitive behavioral therapy (CBT) show promising advantages over single treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of pharmaco- and psychotherapeutic interventions in depression among children and adolescents]. Pössel, P., Hautzinger, M.[2022]

The Acute phase of the cognitive-behavioral therapy (CBT) developed for the Treatment for Adolescents with Depression Study (TADS) includes eight essential skills aimed at addressing adolescent depression, such as mood monitoring and identifying cognitive distortions.

The therapy also offers five optional skills tailored to individual needs, providing flexibility in treatment and addressing common challenges faced by clinicians when implementing CBT for depressed teens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Components of the TADS CBT Approach. Rohde, P., Feeny, NC., Robins, M.[2020]

Cognitive-behavioral therapy (CBT) has been shown to be a well-established and effective treatment for childhood depression, with specific programs like the Penn Prevention Program and Coping with Depression-Adolescent being probably efficacious.

For adolescents, both CBT and interpersonal therapy (IPT) are recognized as having well-established efficacy, with various treatment modalities, including group and individual formats, demonstrating effectiveness in reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based psychosocial treatments for child and adolescent depression. David-Ferdon, C., Kaslow, NJ.[2022]

The study developed a model of therapist competencies specifically for implementing interpersonal psychotherapy for adolescents (IPT-A) in treating depression, using a systematic approach similar to previous work on cognitive behavioral therapy (CBT).

This model provides a framework for training therapists, assessing their competencies, and creating evidence-based guidelines, ensuring that adolescents receive effective treatment for depression in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model of therapist competencies for the empirically supported interpersonal psychotherapy for adolescent depression. Sburlati, ES., Lyneham, HJ., Mufson, LH., et al.[2021]

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]

References

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

Predicting time to recovery among depressed adolescents treated in two psychosocial group interventions. [2019]

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

An open, multisite pilot study of cognitive therapy for depressed adolescents. [2021]

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

Modification of interpersonal psychotherapy with depressed adolescents (IPT-A): phase I and II studies. [2006]

4. Australia pubmed.ncbi.nlm.nih.gov

Family-based interpersonal psychotherapy for depressed preadolescents: an open-treatment trial. [2021]

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

Psychosocial treatments for adolescent depression. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Effects of pharmaco- and psychotherapeutic interventions in depression among children and adolescents]. [2022]

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

Characteristics and Components of the TADS CBT Approach. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Evidence-based psychosocial treatments for child and adolescent depression. [2022]

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

A model of therapist competencies for the empirically supported interpersonal psychotherapy for adolescent depression. [2021]

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

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