Evaluation of a Therapeutic Mobile App for Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Gamified Attention Bias Modification Behavioral intervention designed to decrease negative attention bias. |
Behavioral: Gamified Attention Bias Modification
Behavioral intervention designed to decrease negative attention bias.
|
| Sham Comparator: Gamified Placebo Training Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias |
Behavioral: Gamified Placebo Training
Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias.
|
Outcome Measures
Primary Outcome Measures
- Patient Health Questionnaire - 8 (PHQ-8) [Baseline to Treatment End (4 weeks)]
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
Secondary Outcome Measures
- Ruminative Response Scale - Brooding subscale (RRS-B) [Baseline to Treatment End (4 weeks)]
5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)
- Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale [Baseline to Treatment End (4 weeks)]
3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)
- Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale [Baseline to Treatment End (4 weeks)]
10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)
Other Outcome Measures
- Attention bias (mousetracking) [Weekly assessment over 4 weeks]
Change in scan time for viewing sad stimuli assessed via mousetracking
- General Rumination [daily over 4 weeks]
Change in 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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able and willing to provide informed consent;
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fluent in English;
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normal or corrected-to-normal vision
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moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8);
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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);
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stable psychiatric and neurological medication usage.
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access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments
Exclusion Criteria:
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recent heavy alcohol use defined as 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days
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past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mary Eileen McNamara | Austin | Texas | United States | 78712 |
Sponsors and Collaborators
- University of Texas at Austin
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00003315