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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Response-focused education | Active Comparator | Patient education that is focused on treatment response |
|
| Diagnosis-focused education | Active Comparator | Patient education that is focused on the diagnosis of major depressive disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Response-focused education | Behavioral | Once participants recover from sedation, they will receive education that is focused on their response to treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | 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. | From enrollment to 28 days after treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Sedation awareness | The modified Brice Questionnaire will be used to evaluate what the participant remembers between the time of induction and their awakening from sedation. | Immediately upon recovery from sedation |
| Participant expectations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa Lii, MD, MS | Contact | 650-264-9442 | psychedelicstudies@stanford.edu |
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De-identified participant data, study outcomes, and data dictionaries
Available upon request after publication of the trial's primary findings for up to 5 years.
Researchers must submit a brief proposal and statistical analysis plan for review and approval by the investigators and execute a data sharing agreement.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Diagnosis-focused education | Behavioral | Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder. |
|
Participants will be asked to rate how effective they expect their treatment to be on a scale from 0 (not effective at all) to 100 (completely effective) and indicate the amount of confidence they have on a scale from 0% to 100%.
| From enrollment to 28 days after treatment |
| Sleep disturbance | The 8-item PROMIS Sleep Disturbance Short Form assesses an individual's perception of their sleep quality. Items are self-rated on a 5-point scale ranging from 1 ("Not at all") to 5 ("Very much"). Raw scores are converted to standardized T-scores, with higher a T-score representing more severe sleep disturbance. | From enrollment to 28 days after treatment |
| Anxiety symptoms | The 7-item Generalized Anxiety Disorder (GAD-7) Scale assesses the severity of anxiety symptomsover the past two weeks. Items are self-rated on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), reflecting the frequency of symptoms. Higher total scores indicate greater anxiety symptom severity. | From enrollment to 28 days after treatment |
| Anhedonia | The 14-item Snaith-Hamilton Pleasure Scale (SHAPS) measures an individual's capacity to experience pleasure from various activities over the past two weeks, the absence of which indicates anhedonia. Items are self-rated on a 4-point scale ranging from 0 ("Strongly disagree") to 3 ("Strongly agree"). Lower total scores indicate greater degree of anhedonia. | From enrollment to 28 days after treatment |
| Peace of mind | The 7-item Peace of Mind Scale assesses an individual's overall sense of inner calm and contentment. Items are self-rated on a 5-point scale ranging from 1 ("Not at all") to 5 ("All of the time"). Higher total scores reflect a greater sense of peace of mind. | From enrollment to 28 days after treatment |
| Emotion regulation | The 10-item Emotion Regulation Questionnaire (ERQ) assesses individual differences in the habitual use of cognitive reappraisal and expressive suppression strategies. Items are self-rated on a 7-point Likert scale. Higher scores on the cognitive reappraisal subscale indicate a greater tendency to reinterpret situations to manage emotions, while higher scores on the expressive suppression subscale indicate a greater tendency to inhibit outward emotional expression. | From enrollment to 28 days after treatment |
| Frontal EEG theta power | Electroencephalography (EEG) is a non-invasive technique that records electrical activity of the brain using electrodes placed on the scalp. Theta band (4 to 8 Hz) power in the frontal leads will be compared. | Immediately before sedation start to time of recovery from sedation |
| Adverse events | Safety will be assessed by tracking the number and severity of adverse events spontaneously reported by the participant and through surveillance of medical records (if available) by the research team. Suicidality will be specifically monitored using the Columbia Suicide Severity Rating Scale. | From treatment day to 28 days after treatment |