Precision Psychiatry Continuity Clinic Project (PPC)

Stanford University

Status: Completed

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

Treatments: Other: Feedback Report

Study type: Interventional

Funder types: Other

Identifiers

NCT03260985

41868

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Feedback Group

Experimental group

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.

Treatment:

Other: Feedback Report

Delayed Feedback Group

No Intervention group

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).