- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05767554
Depression, Experiential Diversity, and Behavioral Novelty
August 8, 2024 updated by: Christopher G. Beevers, University of Texas at Austin
Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin Institute of Mental Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Self-reported lifetime diagnosis of agoraphobia or bipolar disorder
- Severe neurodevelopmental disorder
- Major travel plans within study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient Health Questionnaire-8 Total Score over 5 Weeks
Time Frame: Baseline and 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Behavioral Activation for Depression Scale over 5 Weeks
Time Frame: Baseline and 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher G Beevers, PhD, University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
March 2, 2023
First Submitted That Met QC Criteria
March 2, 2023
First Posted (Actual)
March 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 12, 2024
Last Update Submitted That Met QC Criteria
August 8, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003773
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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