Precision Psychiatry Continuity Clinic Project

Not Applicable

Completed

• Conditions: Depressive Disorders; Psychological Distress; Anxiety Disorders and Symptoms; Depressive Symptoms; Mood Disorders
• Interventions: Other: Feedback Report

• Registration Number: NCT03260985
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-24
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback Group	Feedback Report	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.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	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)	12 weeks	A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care

Secondary Outcome Measures

Name	Time	Method
Sheehan Disability Scale (SDS) of Social/Occupational Functioning	12 weeks	Level of functioning in social, occupational, and home life domains
Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)	12 weeks	Burden of side effects from psychiatric medication

Trial Locations

Locations (1)

Stanford Center for Cognitive and Neurobiological Imaging (CNI); 🇺🇸 Stanford, California, United States