NCT05767554

Brief Summary

The purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. The aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via global positioning system location data from a smart phone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

March 2, 2023

Last Update Submit

August 8, 2024

Conditions

Keywords

Behavioral activationMobile sensing

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Health Questionnaire-8 Total Score over 5 Weeks

    Level of depression symptoms assessed weekly by the Patient Health Questionnaire - 8 via smart phone survey. The PHQ-8 ranges from 0-24 with higher scores indicating more severe symptoms of depression.

    Baseline and 5 weeks

Secondary Outcomes (1)

  • Change in Behavioral Activation for Depression Scale over 5 Weeks

    Baseline and 5 weeks

Study Arms (2)

Brief modified behavioral activation

EXPERIMENTAL

Participants randomized to the behavioral activation condition will meet with a graduate level clinician for one hour.

Behavioral: Brief modified behavioral activation

Measurement-only control

NO INTERVENTION

Participants who are not randomized to the active condition will take part in a measurement-only control condition. They will participate in all portions of the study except for the in-person behavioral activation session. They will complete a baseline and fill out daily surveys.

Interventions

The clinician will deliver psychoeducation about the nature of depression and the rationale behind the behavioral activation model (i.e. increasing level of activation can begin a positive feedback cycle of reward and improvements in mood state). Participants will be encouraged to add new, enjoyable activities to their daily schedules. Clinicians will emphasize the importance of novelty and increased engagement with the surrounding environment in the psychoeducational portion and in activity scheduling.

Brief modified behavioral activation

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-25
  • Possession and daily use of a smart phone
  • Able to speak and read English
  • Patient Health Questionnaire -8 (PHQ-8) \> 10
  • Behavioral Activation for Depression (BADS) Activation Subscale \< 16
  • Ability to complete all study procedures

You may not qualify if:

  • Self-reported lifetime diagnosis of agoraphobia or bipolar disorder
  • Severe neurodevelopmental disorder
  • Major travel plans within study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin Institute of Mental Health Research

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Christopher G Beevers, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 14, 2023

Study Start

April 21, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations