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Clinical Trials/NCT03260985
NCT03260985CompletedNot Applicable

Precision Psychiatry Continuity Clinic Project

Stanford University2 sites in 1 country20 target enrollmentStarted: July 25, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Patient Health Questionnaire (PHQ-9)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

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 Outcomes

  • Sheehan Disability Scale (SDS) of Social/Occupational Functioning(12 weeks)
  • Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leanne Williams

Professor

Stanford University

Study Sites (2)

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