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

Not Applicable

Completed

Conditions: Adolescents
Mood Disorders

Interventions: Behavioral: Cognitive behavioral therapy (CBT)

Registration Number: NCT04887155

Lead Sponsor: University of California, Los Angeles

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 91

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy (CBT)_no app	Cognitive behavioral therapy (CBT)	-
Cognitive behavioral therapy (CBT) with mobile app	Cognitive behavioral therapy (CBT)	-

Primary Outcome Measures

Name	Time	Method
Treatment Skill Practice	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	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	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 Outcome Measures

Name	Time	Method
Mobile Application Usability Scale	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
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.	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.
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.	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.
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.	Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.
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.	Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.
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.	Participant-reported psychiatry symptoms. Scores range from 0 - 360 (90 5-point Likert items) with higher scores indicating greater symptom severity.
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.	Participant reported their difficulties with emotion regulation. Scores range from 36 - 180 (36 5-point items) with higher scores indicating greater distress.
KINDL	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.
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.	Parent reported mood, anxiety and stress. Scores range from 0 - 63 (21 4-point items) with higher scores indicating greater distress.