search
Back to results

PERsonalized Mood Augmentation Trial for Depressed Mood (PERMA)

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Behavioral Intervention
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC San Diego Health PsychiatryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalized Behavioral Intervention

Arm Description

Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.

Outcomes

Primary Outcome Measures

PHQ9
Depression Symptoms on the Patient Health Questionnaire 9-item (PHQ9) scale, min 0 max 27 with lower scores representing better outcome

Secondary Outcome Measures

Full Information

First Posted
December 10, 2022
Last Updated
December 21, 2022
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT05662254
Brief Title
PERsonalized Mood Augmentation Trial for Depressed Mood
Acronym
PERMA
Official Title
PERsonalized Mood Augmentation Trial for Depressed Mood
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Behavioral Intervention
Arm Type
Experimental
Arm Description
Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Behavioral Intervention
Intervention Description
Behavioral lifestyle intervention assigned according to each participant's mood and lifestyle data patterns.
Primary Outcome Measure Information:
Title
PHQ9
Description
Depression Symptoms on the Patient Health Questionnaire 9-item (PHQ9) scale, min 0 max 27 with lower scores representing better outcome
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyoti Mishra, PhD
Phone
18582322855
Email
braine@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyoti Mishra, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Health Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyoti Mishra, PhD
Phone
858-232-2855
Email
braine@ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PERsonalized Mood Augmentation Trial for Depressed Mood

We'll reach out to this number within 24 hrs