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This is a demonstration project focused on translating neuroscience insights into clinical practice. The researchers will evaluate how neuroscience assessments may be applied in the clinical setting to help inform care decisions. The aim of the study is to undertake a pragmatic pilot trial to assess whether the inclusion of structured feedback from neuroscience assessments has an effect on improving patient outcomes. The study will investigate how neuroscience assessments can be integrated into and improve clinical care. The impact of sharing information and conclusions from these assessments with psychiatric providers will be explored. Outcomes will include symptoms, social/occupational function and qualify of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feedback Group | Experimental | All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. Participants randomized to the Feedback Group will have the results of this assessment shared with their psychiatric treatment team before they begin treatment. This data will be used at the full discretion of the treatment team to inform personalized treatment options. All treatment decisions remain up to the treatment providers and patient. |
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| Delayed Feedback Group | No Intervention | All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. However, participants randomized to the Delayed Feedback Group will not have the results of this assessment shared with their treatment team until the end of their participation in this study (12 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback Report | Other | A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care | 12 weeks |
| Generalized Anxiety Disorder Questionnaire (GAD-7) | A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Scale (SDS) of Social/Occupational Functioning | Level of functioning in social, occupational, and home life domains | 12 weeks |
| Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Williams, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Center for Cognitive and Neurobiological Imaging (CNI) | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Burden of side effects from psychiatric medication
| 12 weeks |