Depression
Conditions
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.
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.
Interventions
Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).
DEVICEGamified Placebo Training
Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).
Sponsors
Christopher G. Beevers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 8 (PHQ-8) | 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
| Measure | Time frame | Description |
|---|---|---|
| Ruminative Response Scale - Brooding Subscale (RRS-B) | End of treatment (4 week treatment phase) | 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 | End of treatment (4 week treatment phase) | 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 | End of treatment (4 week treatment phase) | 10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants |
| Age, Continuous | 30.88 Years STANDARD_DEVIATION 6.68 |
| Race/Ethnicity, Customized Ethnicity Hispanic/Latino | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 46 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants |
| Race/Ethnicity, Customized Race Declined to answer | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 79 Participants |
| Region of Enrollment United States | 47 participants |
| Sex/Gender, Customized Sex Female | 36 Participants |
| Sex/Gender, Customized Sex Male | 4 Participants |
| Sex/Gender, Customized Sex Other | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
None listed