Precision Psychiatry Continuity Clinic Project
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|ClinicalTrials.gov Identifier: NCT03260985|
Recruitment Status : Enrolling by invitation
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorders Depressive Symptoms Anxiety Disorders and Symptoms Psychological Distress Mood Disorders||Other: Feedback Report||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Precision Psychiatry Continuity Clinic Project|
|Actual Study Start Date :||July 25, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Feedback Group
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.
Other: Feedback Report
A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
No Intervention: Delayed Feedback Group
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).
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 weeks ]A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care
- Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: 12 weeks ]A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care
- Sheehan Disability Scale (SDS) of Social/Occupational Functioning [ Time Frame: 12 weeks ]Level of functioning in social, occupational, and home life domains
- Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) [ Time Frame: 12 weeks ]Burden of side effects from psychiatric medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260985
|United States, California|
|Stanford Center for Cognitive and Neurobiological Imaging (CNI)|
|Stanford, California, United States, 94305|
|Principal Investigator:||Leanne Williams, PhD||Stanford University|