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Precision Psychiatry Continuity Clinic Project (PPC)

Primary Purpose

Depressive Disorders, Depressive Symptoms, Anxiety Disorders and Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feedback Report
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depressive Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Center for Cognitive and Neurobiological Imaging (CNI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Feedback Group

Delayed Feedback Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-9)
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)
A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care

Secondary Outcome Measures

Sheehan Disability Scale (SDS) of Social/Occupational Functioning
Level of functioning in social, occupational, and home life domains
Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
Burden of side effects from psychiatric medication

Full Information

First Posted
August 22, 2017
Last Updated
February 5, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03260985
Brief Title
Precision Psychiatry Continuity Clinic Project
Acronym
PPC
Official Title
Precision Psychiatry Continuity Clinic Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders, Depressive Symptoms, Anxiety Disorders and Symptoms, Psychological Distress, Mood Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Feedback Group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Feedback Report
Intervention Description
A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care
Time Frame
12 weeks
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (SDS) of Social/Occupational Functioning
Description
Level of functioning in social, occupational, and home life domains
Time Frame
12 weeks
Title
Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
Description
Burden of side effects from psychiatric medication
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Williams, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Center for Cognitive and Neurobiological Imaging (CNI)
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Precision Psychiatry Continuity Clinic Project

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