Precision Psychiatry Continuity Clinic Project

NCT03260985 | Completed

• 1 other identifier: 41868
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorders; Depressive Symptoms; Anxiety Disorders and Symptoms; Psychological Distress; Mood Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sheehan Disability Scale (SDS) of Social/Occupational Functioning

  12 weeks

• Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)

  12 weeks

Study Arms (2)

Feedback Group

EXPERIMENTAL

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

Delayed Feedback Group

NO INTERVENTION

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).

Interventions

Feedback Report OTHER

A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.

Feedback Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Center for Cognitive and Neurobiological Imaging (CNI)

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Leanne Williams, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: July 25, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

US (1)