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

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887155
• Other study ID #: 21-000036
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescents
• Mood Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)
Group-based transdiagnostic cognitive-behavioral treatment

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weekly participant adherence	Clinician-rated based on participant report	3-month study period
Primary	Subjective app usability scale	Participant's subjective experience of mobile application. Scores range from 0 - 36 (6 7-point Likert scale items) with higher scores indicating greater subjective usability and acceptability of app	Measured at the end of the 3-month study period
Primary	Psychosocial 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	3-month study period
Primary	Participant app usage	Frequency of participants' app usage	3-month study period
Secondary	Children's Depression Rating Scale, Revised	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) and the end of the three-month study period.
Secondary	Young Mania Rating Scale	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) and the end of the three-month study period.
Secondary	Clinical Global Assessment Scale	Measures overall functioning on a 1-100 scale, with higher scores indicating better functioning.	Measured prior to treatment (0 months) and the end of the three-month study period.
Secondary	Clinical Global Impression	Measures overall clinical functioning from 1-7, with higher scores indicating greater psychiatric severity.	Measured prior to treatment (0 months) and the end of the three-month study period.
Secondary	Symptom Checklist 90	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) and the end of the three-month study period.
Secondary	Depression Anxiety & Stress Scale	Participant 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) and the end of the three-month study period.
Secondary	KINDL	Quality of life measure. Scores range from 0 - 120 (30 5-point items) with higher scores indicating poorer quality of life.	Measured prior to treatment (0 months) and the end of the three-month study period.
Secondary	Depression Anxiety & Stress Scale	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) and the end of the three-month study period.