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Clinical Trials/NCT04887155
NCT04887155
Completed
Not Applicable

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

University of California, Los Angeles1 site in 1 country91 target enrollmentAugust 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescents
Sponsor
University of California, Los Angeles
Enrollment
91
Locations
1
Primary Endpoint
Treatment Skill Practice
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2021
End Date
March 15, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marc J. Weintraub, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

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

  • 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.)
  • Symptom Checklist 90(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(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)
  • KINDL(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(Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.)

Study Sites (1)

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