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Moved institutions, study terminated
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The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.
Attention training programs including mindfulness meditation-based interventions have been shown to be effective for treating depression. Currently the biological and psychological mechanisms of action of attention training for major depression disorder are unknown. The objective of the current study is to improve the investigator's understanding of the mechanisms of attention training interventions for depression.
Research participants will include approximately 165 individuals with major depressive disorder randomized to one of three types of attention training programs. Before and after intervention participants will complete a number of biological assessments including MRI, EEG, behavioral tasks, and questionnaires. The study will be completed across three visits: (1) a screening visit; (2) data collection session 1; and (3) data collection session 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| attention training intervention 1 | Active Comparator | 14-day smartphone-based audio-guided attention training program with heavy mindfulness influence |
|
| attention training intervention 2 | Active Comparator | 14-day smartphone-based audio-guided attention training program with moderate mindfulness influence |
|
| attention training intervention 3 | Active Comparator | 14-day smartphone-based audio-guided intervention without mindfulness emphasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| attention training intervention 1 | Behavioral | 14-day smartphone-based audio-guided attention training program with heavy mindfulness component |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in questionnaire measures including severity of depression (e.g., Beck Depression Inventory [BDI-II]: minimum/maximum values = 0/63, higher scores indicate worse outcome) | pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date) | |
| changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions | pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date) | |
| changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT]) | pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date) | |
| changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task). | pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date) |
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Inclusion Criteria include:
Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D019954 | Neurobehavioral Manifestations |
| D000342 | Affective Symptoms |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| attention training intervention 2 | Behavioral | 14-day smartphone-based audio-guided attention training program with moderate mindfulness component |
|
| attention training intervention 3 | Behavioral | 14-day smartphone-based audio-guided attention training program without mindfulness component |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |