Precision Psychiatry Continuity Clinic Project

NCT ID: NCT03260985

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-12-01

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.

Conditions

Depressive Disorders; Depressive Symptoms; Anxiety Disorders and Symptoms; Psychological Distress; Mood Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Feedback Report

Intervention Type: OTHER

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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Feedback Report

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Leanne Williams

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leanne Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Center for Cognitive and Neurobiological Imaging (CNI)

Stanford, California, United States

Countries

United States

Other Identifiers

41868

Identifier Type: -

Identifier Source: org_study_id