Precision Psychiatry Continuity Clinic Project (PPC)

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: Mood Disorders; Depressive Symptoms; Psychological Distress; Anxiety Disorders and Symptoms; Depressive Disorders
• Intervention / Treatment: Other: Feedback Report

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Center for Cognitive and Neurobiological Imaging (CNI)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Burden of side effects from psychiatric medication	12 weeks

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

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: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Depression; Depressive Disorder; Disease; Anxiety Disorders; Mood Disorders
• 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