Depression, Experiential Diversity, and Behavioral Novelty

Sponsor

University of Texas at Austin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05767554

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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 GPS (global positioning system) location data from a smartphone.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Brief modified behavioral activation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief modified behavioral activation Participants randomized to the behavioral activation condition will meet with a graduate level clinician for one hour.	Behavioral: Brief modified behavioral activation 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 jumpstart 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.
No Intervention: Measurement-only control 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.

Arm

Intervention/Treatment

Experimental: Brief modified behavioral activation

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

Behavioral: Brief modified behavioral activation

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 jumpstart 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.

No Intervention: Measurement-only control

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.

Outcome Measures

Primary Outcome Measures

Change in PHQ-8 Total Score over 5 Weeks [Baseline and 5 weeks]
Level of depression symptoms assessed weekly by the Patient Health Questionnaire - 8 via smartphone survey

Secondary Outcome Measures

Change in BADS over 5 Weeks [Baseline and 5 weeks]
Level of behavioral activation as measured by the Behavioral Activation for Depression Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18-25
Possession and daily use of a smartphone
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin Institute of Mental Health Research	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher G. Beevers, Professor of Psychology, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05767554

Other Study ID Numbers:

STUDY00003773

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christopher G. Beevers, Professor of Psychology, University of Texas at Austin

Behavioral activation

Mobile sensing

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Mar 14, 2023