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OpenTrials
Completed

NCT Number: NCT03260985

Precision Psychiatry Continuity Clinic Project

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.

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Key information

Conditions

Depressive Disorders Anxiety Disorders Anxiety Disorders and Symptoms Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Symptoms Mental Disorders Mood Disorders Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Center for Cognitive and Neurobiological Imaging (CNI)

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feedback Report

Other

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

Primary outcomes

  1. 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

  2. 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

  1. Sheehan Disability Scale (SDS) of Social/Occupational Functioning

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

    Burden of side effects from psychiatric medication

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: PPC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2017
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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