Precision Psychiatry Continuity Clinic Project

Depressive Symptoms Clinical Trial

— PPC  

Official title:

Precision Psychiatry Continuity Clinic Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260985
• Other study ID #: 41868
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Depression
• Depressive Disorder
• Depressive Disorders
• Depressive Symptoms
• Disease
• Mood Disorders
• Psychological Distress

Intervention

Other:
• Feedback Report
A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.

Locations

Country	Name	City	State
United States	Stanford Center for Cognitive and Neurobiological Imaging (CNI)	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sheehan Disability Scale (SDS) of Social/Occupational Functioning	Level of functioning in social, occupational, and home life domains	12 weeks
Secondary	Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)	Burden of side effects from psychiatric medication	12 weeks