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PERMA: PERsonalized Mood Augmentation Trial for Depressed Mood

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT05662254
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
30
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personalized Behavioral Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PERsonalized Mood Augmentation Trial for Depressed Mood
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. PHQ9 [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC San Diego Health Psychiatry San Diego California United States 92127

Sponsors and Collaborators

  • University of California, San Diego

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jyoti Mishra, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT05662254
Other Study ID Numbers:
  • PERMA
First Posted:
Dec 22, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Dec 23, 2022