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Depression, Experiential Diversity, and Behavioral Novelty

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief modified behavioral activation
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Behavioral activation, Mobile sensing

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas at Austin Institute of Mental Health ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief modified behavioral activation

Measurement-only control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 2, 2023
Last Updated
May 10, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05767554
Brief Title
Depression, Experiential Diversity, and Behavioral Novelty
Official Title
Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Behavioral activation, Mobile sensing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief modified behavioral activation
Arm Type
Experimental
Arm Description
Participants randomized to the behavioral activation condition will meet with a graduate level clinician for one hour.
Arm Title
Measurement-only control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief modified behavioral activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-8 Total Score over 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks
Secondary Outcome Measure Information:
Title
Change in Behavioral Activation for Depression Scale over 5 Weeks
Description
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.
Time Frame
Baseline and 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mackenzie Zisser, MA
Phone
512- 232-4750
Email
mdl@utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher G Beevers, PhD
Phone
512- 232-4750
Email
mdl@utexas.edu
Facility Information:
Facility Name
University of Texas at Austin Institute of Mental Health Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher G Beevers, PhD
Phone
512-232-4750
Email
mdl@utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Depression, Experiential Diversity, and Behavioral Novelty

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