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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamified Attention Bias Modification | Active Comparator | Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias. |
|
| Gamified Placebo Training | Sham Comparator | Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamified Attention Bias Modification | Device | Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT). |
|
| 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) | End of treatment (4 week treatment phase) |
| 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) | End of treatment (4 week treatment phase) |
| Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage From" Subscale |
| Measure | Description | Time Frame |
|---|---|---|
| Attention Bias (Mousetracking) | Mean scan time for viewing sad stimuli assessed via mousetracking, controlling for baseline score | End of treatment (4 week treatment phase) |
| General Rumination | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary Eileen McNamara | Austin | Texas | 78712 | United States |
De-identified data will be made available upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Training | In this group, participants were trained to look at happy faces over sad faces 80% of the time. |
| FG001 | Control Training | In this condition, participants were trained to look at happy faces only 50% of the time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gamified Attention Bias Modification | Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias. Gamified Attention Bias Modification: Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Health Questionnaire - 8 (PHQ-8) | 8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity) | Posted | Least Squares Mean | Standard Error | points | End of treatment (4 week treatment phase) |
|
From enrollment to end of participation (up to 4 weeks after enrollment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Training | In this group, participants were trained to look at happy faces over sad faces 80% of the time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary McNamara | Mass General Brigham | 617-855-3466 | mmcnamara14@mgb.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 2, 2023 | Apr 19, 2026 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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). |
|
3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination) |
| End of treatment (4 week treatment phase) |
| 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) | End of treatment (4 week treatment phase) |
| Assessed daily over 4 weeks, end of treatment at week 4 reported |
| Gamified Placebo Training |
Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were asked, "What is your race? Select all that apply." | Some participants may have identified with more than one race. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Ruminative Response Scale - Brooding Subscale (RRS-B) | 5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination) | Posted | Least Squares Mean | Standard Error | points | End of treatment (4 week treatment phase) |
|
|
|
|
| Secondary | 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) | Posted | Least Squares Mean | Standard Error | points | End of treatment (4 week treatment phase) |
|
|
|
|
| Secondary | 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) | Posted | Least Squares Mean | Standard Error | points | End of treatment (4 week treatment phase) |
|
|
|
|
| Other Pre-specified | Attention Bias (Mousetracking) | Mean scan time for viewing sad stimuli assessed via mousetracking, controlling for baseline score | Posted | Least Squares Mean | Standard Error | milliseconds | End of treatment (4 week treatment phase) |
|
|
|
|
| Other Pre-specified | General Rumination | 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 | Posted | Least Squares Mean | Standard Error | points | Assessed daily over 4 weeks, end of treatment at week 4 reported |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Control Training | In this condition, participants were trained to look at happy faces only 50% of the time. | 0 | 55 | 0 | 55 | 0 | 55 |
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