PPC: Precision Psychiatry Continuity Clinic Project

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03260985
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 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: Jul 25, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire (PHQ-9) [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) [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 [12 weeks]

   Level of functioning in social, occupational, and home life domains

2. Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) [12 weeks]

   Burden of side effects from psychiatric medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leanne Williams, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03260985
• Other Study ID Numbers: 41868
• First Posted: Aug 24, 2017
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• 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

Study Results

No Results Posted as of Feb 7, 2020