NCT05662254

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

December 10, 2022

Last Update Submit

March 24, 2025

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • PHQ9

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

    12 weeks

Study Arms (1)

Personalized Behavioral Intervention

EXPERIMENTAL

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

Behavioral: Personalized Behavioral Intervention

Interventions

Personalized Behavioral InterventionBEHAVIORAL

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

Personalized Behavioral Intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate depression per PHQ9 symptom ratings

You may not qualify if:

  • active substance abuse/dependence
  • psychotic disorders
  • bipolar disorder
  • eating disorder
  • displaying acutely suicidal behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego Health Psychiatry

San Diego, California, 92127, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jyoti Mishra, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2022

First Posted

December 22, 2022

Study Start

June 1, 2022

Primary Completion

July 15, 2024

Study Completion

October 11, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)