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CompletedNCT03260985PPCUpdated Feb 7, 2020

Precision Psychiatry Continuity Clinic Project

An interventional study of Feedback Report in Depressive Disorders, Depressive Symptoms and Anxiety Disorders and Symptoms, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorders
  • Depressive Symptoms
  • Anxiety Disorders and Symptoms
  • Psychological Distress
  • Mood Disorders
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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).

Interventions

  • OtherFeedback Report

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

05

What researchers measure

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

Secondary outcomes

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

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

    Time frame: 12 weeks

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

    Burden of side effects from psychiatric medication

    Time frame: 12 weeks

06

Study locations

1 site
  • Stanford Center for Cognitive and Neurobiological Imaging (CNI)
    Stanford, California 94305, United States
07

Registry details

Key details

Study ID
NCT03260985
Lead sponsor
Stanford University
Responsible party
Leanne Williams (Professor, Stanford University) — Principal investigator
First posted
Aug 24, 2017
Start date
Jul 25, 2017
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Feb 7, 2020

Study contacts

Leanne Williams, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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