Depression, Experiential Diversity, and Behavioral Novelty

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767554
• Other study ID #: STUDY00003773
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: University of Texas at Austin
• Contact: Mackenzie Zisser, MA
• Phone: 512- 232-4750
• Email: mdl[@]utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Austin Institute of Mental Health Research	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-8 Total Score over 5 Weeks	Level of depression symptoms assessed weekly by the Patient Health Questionnaire - 8 via smartphone survey. The PHQ-8 ranges from 0-24 with higher scores indicating more severe symptoms of depression.	Baseline and 5 weeks
Secondary	Change in Behavioral Activation for Depression Scale over 5 Weeks	Level of behavioral activation as measured by the Behavioral Activation for Depression Scale (BADS). The BADS ranges from 0-150 with higher scores indicating better functioning.	Baseline and 5 weeks