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Evaluation of a Therapeutic Mobile App for Depression

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamified Attention Bias Modification
Gamified Placebo Training
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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: able and willing to provide informed consent; fluent in English; normal or corrected-to-normal vision moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8); attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task); stable psychiatric and neurological medication usage. access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments Exclusion Criteria: recent heavy alcohol use defined as a score of 2 or higher on the PDSQ past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.) previous experience with gamified attention bias modification app

Sites / Locations

  • Mary Eileen McNamara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Gamified Attention Bias Modification

Gamified Placebo Training

Arm Description

Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias.

Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias

Outcomes

Primary Outcome Measures

Patient Health Questionnaire - 8 (PHQ-8)
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)

Secondary Outcome Measures

Ruminative Response Scale - Brooding subscale (RRS-B)
5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)
Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale
3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)
Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale
10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)

Full Information

First Posted
October 26, 2022
Last Updated
August 30, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05601362
Brief Title
Evaluation of a Therapeutic Mobile App for Depression
Official Title
Evaluation of a Therapeutic Mobile App for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is a preliminary evaluation of a gamified attention bias modification training (GAMBT) for reducing symptoms of depression and rumination. Individuals with elevated symptoms of depression will use the digital intervention over the course of 4 weeks. They will complete a brief (~5 question) survey daily, as well as weekly assessments.
Detailed Description
This study aims to assess the feasibility and efficacy of the digital therapeutic attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. Consistent with the experimental therapeutics approach ABM has been shown to both reduce negative attention bias and improve symptoms of depression. However, engagement with these tasks have been mixed, with some participants describing traditional ABM tasks as boring. This had led to the development of gamified versions of ABM with the intent to improve participant engagement. Nevertheless, there have been very few rigorous trials of ABM for depression, and no one to our knowledge has used ecological momentary assessment to tease apart the mechanisms by which ABM can lead to improvements in depression symptoms. Participants will access the intervention on their mobile smart phone and complete treatment over a period of 4 weeks. Enrolled participants will be randomly assigned to one of two groups: Gamified attention bias modification training, or gamified placebo training. They will complete brief (~5 questions) daily surveys, as well as weekly remote assessments of attention bias and depression symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gamified Attention Bias Modification
Arm Type
Active Comparator
Arm Description
Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias.
Arm Title
Gamified Placebo Training
Arm Type
Sham Comparator
Arm Description
Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias
Intervention Type
Device
Intervention Name(s)
Gamified Attention Bias Modification
Intervention Description
Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).
Intervention Type
Device
Intervention Name(s)
Gamified Placebo Training
Intervention Description
Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - 8 (PHQ-8)
Description
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
Time Frame
Baseline to Treatment End (4 weeks)
Secondary Outcome Measure Information:
Title
Ruminative Response Scale - Brooding subscale (RRS-B)
Description
5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)
Time Frame
Baseline to Treatment End (4 weeks)
Title
Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale
Description
3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)
Time Frame
Baseline to Treatment End (4 weeks)
Title
Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale
Description
10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)
Time Frame
Baseline to Treatment End (4 weeks)
Other Pre-specified Outcome Measures:
Title
Attention bias (mousetracking)
Description
Change in scan time for viewing sad stimuli assessed via mousetracking
Time Frame
Weekly assessment over 4 weeks
Title
General Rumination
Description
Change in rumination (assessed via smartphone-delivered ecological momentary assessment items used in prior EMA research (Smith et al., 2021)). (Range: 4-20, higher scores indicate more rumination)
Time Frame
daily over 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: able and willing to provide informed consent; fluent in English; normal or corrected-to-normal vision moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8); attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task); stable psychiatric and neurological medication usage. access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments Exclusion Criteria: recent heavy alcohol use defined as a score of 2 or higher on the PDSQ past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.) previous experience with gamified attention bias modification app
Facility Information:
Facility Name
Mary Eileen McNamara
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available upon study completion.

Learn more about this trial

Evaluation of a Therapeutic Mobile App for Depression

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