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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 weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
Awards & highlights
Study Summary
This trial is testing a new mobile phone application that will send weekly alerts to adolescents with mood instability and their families. The app is designed to help the family communicate and solve problems better. The investigators hope that this will lead to improved symptoms and quality of life for the adolescent.
Eligible Conditions
- Bipolar Disorder
- Mood Disorders
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mean children's affective lability scores computed at baseline and every 9 weeks for 27 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean children's affective lability scores computed at baseline and every 9 weeks for 27 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average mood symptom scores over 27 weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Secondary outcome measures
Expressed emotion in parents from the Five Minute Speech Sample
Free speech samples coded using the Linguistic Inquiry Word Count system.
Mood instability, as rated by parents and children using the Children's Affective Lability Scale (CALS) and the Parent-Rated General Behavior Inventory
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
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,737 Total Patients Enrolled
12 Trials studying Bipolar Disorder
949 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,062 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,520 Patients Enrolled for Bipolar Disorder
Armen Arevian, MDPrincipal InvestigatorUniversity of California, Los Angeles
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