- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03260985
Precision Psychiatry Continuity Clinic Project (PPC)
February 5, 2020 updated by: Leanne Williams, Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford Center for Cognitive and Neurobiological Imaging (CNI)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sheehan Disability Scale (SDS) of Social/Occupational Functioning
Time Frame: 12 weeks
|
Level of functioning in social, occupational, and home life domains
|
12 weeks
|
Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
Time Frame: 12 weeks
|
Burden of side effects from psychiatric medication
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 25, 2017
Primary Completion (ACTUAL)
December 1, 2019
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
August 22, 2017
First Submitted That Met QC Criteria
August 23, 2017
First Posted (ACTUAL)
August 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41868
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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