MedDataX Logo

Evaluation of a Therapeutic Mobile App for Depression

NCT ID: NCT05601362

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gamified Attention Bias Modification

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

Group Type ACTIVE_COMPARATOR

Gamified Attention Bias Modification

Intervention Type DEVICE

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

Gamified Placebo Training

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

Group Type SHAM_COMPARATOR

Gamified Placebo Training

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gamified Attention Bias Modification

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

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mary Eileen McNamara

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00003315

Identifier Type: -

Identifier Source: org_study_id