Evaluation of a Therapeutic Mobile App for Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Therapeutic Mobile App for Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Gamified Attention Bias Modification
* Device: Gamified Placebo Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) |