Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders

NCT ID: NCT04887155

Last Updated: 2025-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2024-03-15

Brief Summary

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Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.

Detailed Description

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Conditions

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Adolescents Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive behavioral therapy (CBT)_no app

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Group-based transdiagnostic cognitive-behavioral treatment

Cognitive behavioral therapy (CBT) with mobile app

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Group-based transdiagnostic cognitive-behavioral treatment

Interventions

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Cognitive behavioral therapy (CBT)

Group-based transdiagnostic cognitive-behavioral treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Meet DSM-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder
2. Be 13-17 years old
3. English speaking and able to complete written questionnaires
4. Ability to attend pre-determined group session time(s)
5. Access to a smartphone to engage with the study app
6. Medication usage is acceptable, but not required

Exclusion Criteria

1. Regular use or current abuse of a psychoactive drug
2. Evidence of behavioral problems that are thought to interfere with group treatment
3. Suicidality that requires more intensive treatment
4. Meeting DSM 5 criteria for bipolar I or II disorder, a psychotic disorder, or significant psychiatric symptoms (e.g., self-injurious behavior) that require more intensive treatment
5. Concurrent participation in cognitive-behavioral therapy
6. Inability to travel to study sessions and assessments
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Marc J. Weintraub, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Semel Institute

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Weintraub MJ, Ichinose MC, Zinberg JL, Salimian A, Brown RD, Morgan-Fleming G, Gamarra JM, Tran T, Miklowitz DJ. A randomized trial of an app-enhanced group cognitive behavioral therapy for adolescents with mood or psychotic spectrum disorders. J Consult Clin Psychol. 2025 Mar;93(3):131-143. doi: 10.1037/ccp0000946.

Reference Type DERIVED
PMID: 40014504 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21-000036

Identifier Type: -

Identifier Source: org_study_id

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