Evaluation of a Therapeutic Mobile App for Depression

NCT05601362 | Completed FDA Device

• 1 other identifier: STUDY00003315
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ruminative Response Scale - Brooding subscale (RRS-B)

  Baseline to Treatment End (4 weeks)

• Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale

  Baseline to Treatment End (4 weeks)

• Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale

  Baseline to Treatment End (4 weeks)

Other Outcomes (2)

• Attention bias (mousetracking)

  Weekly assessment over 4 weeks

• General Rumination

  daily over 4 weeks

Study Arms (2)

Gamified Attention Bias Modification

ACTIVE COMPARATOR

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

Device: Gamified Attention Bias Modification

Gamified Placebo Training

SHAM COMPARATOR

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

Device: Gamified Placebo Training

Interventions

Gamified Attention Bias Modification DEVICE

Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).

Gamified Attention Bias Modification

Gamified Placebo Training DEVICE

Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).

Gamified Placebo Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Mary Eileen McNamara

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: March 30, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)