Clinical trial NCT04887155: Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders
Official title: Mobile-enhanced Transdiagnostic Group Treatment for Adolescents at Risk for Severe Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents
Mood Disorders
Keywords: cognitive behavioral therapy (CBT)
mobile health (mHealth)
Group treatment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 91
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Skill Practice
timeFrame: 9-week treatment period
measure: Psychosocial Treatment Compliance Scale
timeFrame: 9-week treatment
measure: Mobile Application Use
timeFrame: 9-week treatment period
Secondary outcomes:
measure: Mobile Application Usability Scale
timeFrame: Measured at the end of the 9-week treatment period
measure: Children's Depression Rating Scale, Revised
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Young Mania Rating Scale
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Clinical Global Assessment Scale
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Clinical Global Impression
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Symptom Checklist 90
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Difficulties With Emotion Regulation
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: KINDL
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
measure: Depression Anxiety & Stress Scale
timeFrame: Measured prior to treatment (0 months), at the end of the 9-week treatment, and the end of the 21-week study period.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
References: