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

NCT04887155 | Completed Results

• 1 other identifier: 21-000036
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescents; Mood Disorders

Keywords

cognitive behavioral therapy (CBT); mobile health (mHealth); Group treatment

Outcome Measures

Primary Outcomes (3)

• Treatment Skill Practice

  Sum of all treatment skill practices completed through the course of the treatment (based on adolescent report).

  9-week treatment period

• Psychosocial Treatment Compliance Scale

  Clinician-rated of participant overall treatment compliance. Scores range from 17-85 (17 5-point Likert scale items) with higher scores indicating greater treatment compliance.

  9-week treatment

• Mobile Application Use

  Frequency of mobile application (app) usage within the condition that received the mobile application, ranging from 0 to unlimited maximum with higher scores indicating more app usage.

  9-week treatment period

Secondary Outcomes (9)

• Mobile Application Usability Scale

  Measured at the end of the 9-week treatment period

• Children's Depression Rating Scale, Revised

  Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

• Young Mania Rating Scale

  Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

• Clinical Global Assessment Scale

  Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

• Clinical Global Impression

  Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

Study Arms (2)

Cognitive behavioral therapy (CBT)_no app

ACTIVE COMPARATOR

Behavioral: Cognitive behavioral therapy (CBT)

Cognitive behavioral therapy (CBT) with mobile app

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Cognitive behavioral therapy (CBT) BEHAVIORAL

Group-based transdiagnostic cognitive-behavioral treatment

Cognitive behavioral therapy (CBT) with mobile app; Cognitive behavioral therapy (CBT)_no app

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Regular use or current abuse of a psychoactive drug
• Evidence of behavioral problems that are thought to interfere with group treatment
• Suicidality that requires more intensive treatment
• 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
• Concurrent participation in cognitive-behavioral therapy
• Inability to travel to study sessions and assessments

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095-8353, United States

Location

Related Publications (1)

• 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.

  PMID: 40014504 DERIVED

MeSH Terms

Conditions

Mood Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Most of the adolescents were diagnosed with a depressive spectrum disorder. Ratings of skill practice were made based on adolescent and clinician report, but there was no definitive method of confirming skill practice completion in the standard UP group, nor was there any examination of the proficiency/quality of skill practice across both conditions.

Results Point of Contact

• Title: Marc Weintraub
• Organization: UCLA Semel Institute

mjweintraub@mednet.ucla.edu

3108251300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 14, 2021
• Study Start: August 30, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Locations

US (1)