NCT05601362

Evaluation of a Therapeutic Mobile App for Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

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

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-11-01
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study