Evaluation of a Therapeutic Mobile App for Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Gamified Attention Bias Modification; Device: Gamified Placebo Training

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Mary Eileen McNamara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Gamified Placebo Training; Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias	Device: Gamified Placebo Training; Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).
Active Comparator: Gamified Attention Bias Modification; Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias.	Device: Gamified Attention Bias Modification; Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 8 (PHQ-8)	8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)	Baseline to Treatment End (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ruminative Response Scale - Brooding subscale (RRS-B)	5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)	Baseline to Treatment End (4 weeks)
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)	Baseline to Treatment End (4 weeks)
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)	Baseline to Treatment End (4 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention bias (mousetracking)	Change in scan time for viewing sad stimuli assessed via mousetracking	Weekly assessment over 4 weeks
General Rumination	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)	daily over 4 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY00003315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes