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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04887155
Other study ID # 21-000036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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