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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03260985
Other study ID # 41868
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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