PERsonalized Mood Augmentation Trial for Depressed Mood (PERMA)

March 24, 2025 updated by: Jyoti Mishra, University of California, San Diego
The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92127
        • UC San Diego Health Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Behavioral Intervention
Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.
Behavioral: Personalized Behavioral Intervention
Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Jyoti Mishra, PhD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

October 11, 2024

Study Registration Dates

First Submitted

December 10, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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