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Family-Focused Treatment with MCC App for Bipolar Disorder

Phase 1 & 2

Waitlist Available

Led By Armen Arevian, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcomes scores at 27 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a family therapy combined with a mobile app to help teens with mood issues and their parents. The app tracks moods and interactions, giving real-time advice to improve family dynamics and mood stability. Integrating psychosocial interventions with mobile apps may increase treatment engagement among adolescents.

Eligible Conditions

Bipolar Disorder
Affective Disorder
Mood Disorders
Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcomes scores at 27 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcomes scores at 27 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcomes scores at 27 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation

Secondary study objectives

Children's Global Assessment of Functioning

Expressed Emotion in Parents From the Five Minute Speech Sample

Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.

+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 65 Patients • NCT03913013

22%

Self-harm, with or without suicidal ideation

16%

Inpatient hospitalization or Emergency Room visit

100%

80%

60%

40%

20%

Study treatment Arm

FFT With MCC App (FFT-MCC)

FFT With App Assessments Only (FFT-Assess)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FFT with MCC App (FFT-MCC)Experimental Treatment1 Intervention

Youth in this study arm will receive 12 sessions of FFT (psychoeducation, communication skills training, and problem-solving skills training) with their parents and siblings. They and their parents will make regular mobile app ratings of mood, sleep, family functioning, stress, and perceived criticism. Children and parents will call into a voice-activated phone system and be asked to speak freely for 3-5 minutes about their health and family functioning. They will be guided through 12 lesson plans in which they practice skills such as active listening or identifying prodromal signs of episodes, paralleling what they are learning in sessions. The clinician will be able to set a weekly skill training assignment and observe the family's practice of the skill between sessions. They will adapt session content accordingly.

Group II: FFT with App Assessments only (FFT-Assess)Active Control1 Intervention

Youth in this condition will receive the same 12 sessions of FFT, but the app will be limited to daily and weekly assessments of their mood, sleep, stress, and family functioning. The app will not provide the skill training offered in the FFT-MCC condition.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Family-Focused Treatment with MCC App

2018

Completed Phase 2

~70

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