What side effects are associated with this type of intervention?

Common treatments for depression, such as cognitive-behavioral therapy (CBT) and pharmacotherapy, have distinct side effect profiles. CBT is generally well-tolerated, though some patients may experience temporary increases in anxiety or emotional discomfort. Pharmacotherapy, particularly SSRIs and SNRIs, can cause side effects including nausea, insomnia, sexual dysfunction, and weight gain. The specific side effects can vary based on the medication and individual patient response.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and paroxetine, as well as serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine. These medications are often used in combination with psychotherapies like cognitive-behavioral therapy (CBT) and interpersonal therapy (IPT), which are similar to the approaches being studied in the CATCH-IT trial. The combination of pharmacotherapy and psychotherapy has been shown to be more effective than either treatment alone for many patients with depression.

What other types of research exist?

Promising novel alternatives to CATCH-IT for depression treatment in 2024 include: 1) Internet-delivered acceptance-based behavior therapy (I-BT), which incorporates habit reversal and mindfulness techniques; 2) Wearable biocueing interventions like the Sense-IT app, which uses real-time feedback to manage symptoms; and 3) Transdiagnostic cognitive-behavioral therapy (CBT), which addresses a range of emotional disorders and has shown long-term efficacy in clinical trials.

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Behavioral Intervention

Cognitive Behavioral Therapy for Adolescent Depression (PATHway Trial)

N/A

Recruiting

Led By Tracy RG Gladstone, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescents ages 13 through 18 years

Adolescents ages 13 through 18 years,

Must not have

Parent/guardian has a cognitive or intellectual impairment

Any past suicide attempt or incident of self-harm with moderate or greater lethality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start to end of recruitment, 32 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As CATCH-IT is a non-medical intervention focusing on behavioral training, traditional side effects associated with medications are not expected. However, participants might experience discomfort discussing personal issues or temporary increases in distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 18 years old.

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I am between 13 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have attempted suicide or self-harmed with moderate or greater severity.

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I am an adolescent who does not speak or read English.

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I am currently on medication for depression, anxiety, or similar conditions.

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I am experiencing thoughts of harming myself.

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I have not had suicidal thoughts in the last 6 months.

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I am between the ages of 13 and 18.

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I am currently receiving treatment for a mood disorder.

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I am not willing to follow the study rules.

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My parent or guardian does not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start to end of recruitment, 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start to end of recruitment, 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and start to end of recruitment, 32 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention

Anxiety Symptoms

Body Mass Index

+24 more

Secondary study objectives

Moderation of COVID-19-related behaviors and consequences

Moderation of COVID-19-related social determinants of health

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Active Control

Group I: 9. Parent program modules onlyExperimental Treatment1 Intervention

Parent program modules

Group II: 8. Full Adolescent program onlyExperimental Treatment1 Intervention

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

Group III: 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modulesExperimental Treatment1 Intervention

Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules

Group IV: 6. Adolescent behavioral activation modules + interpersonal therapy modulesExperimental Treatment1 Intervention

Adolescent behavioral activation modules Adolescent interpersonal therapy modules

Group V: 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modulesExperimental Treatment1 Intervention

Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules

Group VI: 4. Adolescent interpersonal therapy modules onlyExperimental Treatment1 Intervention

Adolescent interpersonal therapy modules only

Group VII: 3. Adolescent cognitive-behavioral therapy modules onlyExperimental Treatment1 Intervention

Adolescent cognitive-behavioral therapy modules only

Group VIII: 2. Adolescent behavioral activation modules onlyExperimental Treatment1 Intervention

Adolescent behavioral activation modules only

Group IX: 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modulesExperimental Treatment1 Intervention

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

Group X: 14. Adolescent behavioral activation + interpersonal therapy + parent program modulesExperimental Treatment1 Intervention

Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules

Group XI: 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modulesExperimental Treatment1 Intervention

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

Group XII: 12. Adolescent interpersonal therapy modules + parent program modulesExperimental Treatment1 Intervention

Adolescent interpersonal therapy modules Parent Program

Group XIII: 11. Adolescent cognitive-behavioral therapy modules + parent program modulesExperimental Treatment1 Intervention

Adolescent cognitive-behavioral therapy modules Parent program modules

Group XIV: 10. Adolescent behavioral activation modules + parent program modulesExperimental Treatment1 Intervention

Adolescent behavioral activation modules Parent program modules

Group XV: 1. No adolescent modules + no parent modulesActive Control1 Intervention

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

Group XVI: 16. All adolescent + parent program modulesActive Control1 Intervention

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as cognitive-behavioral therapy (CBT), humanistic therapy, and interpersonal therapy, work through different mechanisms. CBT focuses on altering negative thought patterns and behaviors, helping patients develop healthier ways of thinking and coping. Humanistic therapy emphasizes personal growth and self-actualization, encouraging patients to explore their feelings and self-worth. Interpersonal therapy addresses relationship issues and social functioning, aiming to improve communication skills and social support. Understanding these mechanisms is crucial for depression patients as it helps them recognize how these therapies can target specific aspects of their condition, leading to more effective and personalized treatment plans.

Brief psychotherapy: current status.Practitioner Review: School refusal: developments in conceptualisation and treatment since 2000.Editorial introduction.