Anxiety Disorders and Symptoms, Depressive Disorders, Depressive Symptoms, Mood Disorders, Psychological Distress
Conditions
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.
Interventions
OTHERFeedback Report
A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed