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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
Sponsor:
Information provided by (Responsible Party):
Leanne Williams, Stanford University

Brief Summary:
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.

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Sheehan Disability Scale (SDS) of Social/Occupational Functioning [ Time Frame: 12 weeks ]
    Level of functioning in social, occupational, and home life domains

  2. Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) [ Time Frame: 12 weeks ]
    Burden of side effects from psychiatric medication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18+ years of age
  • Fluent and literate in English, and able to understand task instructions
  • fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)
  • Must be referred for treatment at the Stanford Department of Psychiatry Continuity Clinic

Exclusion Criteria:

  • Presence of suicidal ideations representing imminent risk
  • General medical condition, disease or neurological disorder that interferes with the assessments
  • Traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
  • Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
  • Pregnancy
  • Presence of acute psychosis, schizophrenia spectrum, or other psychotic disorders
  • Concurrent participation in intervention or treatment studies

Information from the National Library of Medicine

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


Locations
United States, California
Stanford Center for Cognitive and Neurobiological Imaging (CNI)
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Leanne Williams, PhD Stanford University

Responsible Party: Leanne Williams, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03260985     History of Changes
Other Study ID Numbers: 41868
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms