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NCT05662254 Clinical Trial

PERsonalized Mood Augmentation Trial for Depressed Mood

Depression Clinical Trial

— PERMA  

Official title:
PERsonalized Mood Augmentation Trial for Depressed Mood

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05662254
Other study ID # PERMA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 2024

Study information
Verified date January 2024
Source University of California, San Diego
Contact Jyoti Mishra, PhD
Phone 18582322855
Email braine@ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood.

Description:

The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood. After an initial period (2-4 weeks) of mood and lifestyle monitoring using smartphone and smartwatch data, participants will be assigned to an evidenced-based behavioral plan that target their lifestyle for 6 weeks. The trial will evaluate changes in depressed mood, associated health behaviors and cognition.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - Mild to moderate depression per PHQ9 symptom ratings Exclusion Criteria: - active substance abuse/dependence - psychotic disorders - bipolar disorder - eating disorder - displaying acutely suicidal behaviors

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Personalized Behavioral Intervention
Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.

Locations
Country Name City State
United States UC San Diego Health Psychiatry San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PHQ9 Depression Symptoms on the Patient Health Questionnaire 9-item (PHQ9) scale, min 0 max 27 with lower scores representing better outcome 12 weeks
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