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Completed

NCT Number: NCT05601362

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mary Eileen McNamara

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gamified Attention Bias Modification

Device

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

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).

Primary outcomes

  1. Patient Health Questionnaire - 8 (PHQ-8)

    Time frame: End of treatment (4 week treatment phase)

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

Secondary outcomes

  1. Ruminative Response Scale - Brooding Subscale (RRS-B)

    Time frame: End of treatment (4 week treatment phase)

    5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)

  2. Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage From" Subscale

    Time frame: End of treatment (4 week treatment phase)

    3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)

  3. Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Subscale

    Time frame: End of treatment (4 week treatment phase)

    10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)

Other outcomes

  1. Attention Bias (Mousetracking)

    Time frame: End of treatment (4 week treatment phase)

    Mean scan time for viewing sad stimuli assessed via mousetracking, controlling for baseline score

  2. General Rumination

    Time frame: Assessed daily over 4 weeks, end of treatment at week 4 reported

    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); tested time by condition interaction

Sponsors and collaborators

Lead sponsor

Christopher G. Beevers

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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