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

May 21, 2025 updated by: Marc J. Weintraub, PhD, University of California, Los Angeles

Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-8353
        • UCLA Semel Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive behavioral therapy (CBT)_no app
Behavioral: Cognitive behavioral therapy (CBT)
Group-based transdiagnostic cognitive-behavioral treatment
Experimental: Cognitive behavioral therapy (CBT) with mobile app
Behavioral: Cognitive behavioral therapy (CBT)
Group-based transdiagnostic cognitive-behavioral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Skill Practice
Time Frame: 9-week treatment period
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
Time Frame: 9-week treatment
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
Time Frame: 9-week treatment period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobile Application Usability Scale
Time Frame: Measured at the end of the 9-week treatment period
Mobile application (app) acceptability as rated on a 5-point scale (i.e., minimum = 1, maximum = 5) with higher values indicating greater acceptability
Measured at the end of the 9-week treatment period
Children's Depression Rating Scale, Revised
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Measures depressive symptom severity. Scores range from 17-113 (14 7-point items and 3 5-point items) with higher scores indicating greater depressive severity.
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
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Measure manic symptom severity. Scores range from 0-60 (7 5-point items and 4 9-point items) with higher scores indicating greater manic severity.
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
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.
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
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Symptom Checklist 90
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity.
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Difficulties With Emotion Regulation
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress.
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
KINDL
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating better quality of life.
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Depression Anxiety & Stress Scale
Time Frame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress.
Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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