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Completed

NCT Number: NCT04887155

Mobile-enhanced Group CBT for Adolescents at Risk 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.

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Key information

Conditions

Adolescents Mental Disorders Mood Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute

Los Angeles, California, 90095-8353, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

Group-based transdiagnostic cognitive-behavioral treatment

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 14, 2021
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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