Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
Overview
- Phase
- N/A
- Intervention
- Response-focused education
- Conditions
- Major Depressive Disorder (MDD)
- Sponsor
- Stanford University
- Enrollment
- 20
- Primary Endpoint
- Depression severity
- Status
- Not Yet Recruiting
- Last Updated
- 8 days ago
Overview
Brief Summary
The goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. In this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic which might have antidepressant properties.
The main question this study aims to answer is: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?
Researchers will compare response-focused vs. diagnosis-focused education.
Qualifying participants will:
- Undergo a single intravenous infusion of propofol which will induce a temporary state of sedation
- Wear an EEG cap that records brain activity during sedation
- Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation
- Be asked to fill out surveys about their mood and other measures of well-being before and after treatment
Investigators
Theresa Lii
Principal Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of major depressive disorder of at least moderate severity
- •Able to read, understand, and provide written informed consent
Exclusion Criteria
- •Pregnant or breastfeeding
- •Certain substance use disorders
- •Daily use of opioids and/or benzodiazepines
- •History of psychosis, schizophrenia, or schizoaffective disorder
- •Body mass index greater than 35 kg/m2
- •Obstructive sleep apnea that is moderate and untreated, or severe
- •Any gastrointestinal condition placing the patient at significant risk of aspiration
Arms & Interventions
Response-focused education
Patient education that is focused on treatment response
Intervention: Response-focused education
Diagnosis-focused education
Patient education that is focused on the diagnosis of major depressive disorder
Intervention: Diagnosis-focused education
Outcomes
Primary Outcomes
Depression severity
Time Frame: From enrollment to 28 days after treatment
The 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR-16) assesses the severity of depressive symptoms experienced by an individual. Items are self-rated on a 4-point scale tailored to each depression symptom. Higher total scores indicate greater depression severity.