Trial · NCT06355414
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete) | Discrete positive affect items: joy, love, hope, contentment. Positive affect will be assessed by asking participants to rate the intensity of four discrete positive emotions (joy, love, hope, contentment) on a 5-point Likert scale from 1-5 ("Very slightly or not at all" to "Extremely") and averaging those discrete items. Positive Affect scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Higher Positive Affect scores represent higher levels of positive affect. A separate set of linear mixed-effects models (LMERs) will be utilized for each primary endpoint (aggregated averages of momentary positive affect), with a primary LMER estimating the difference between Baseline and Week 1. The Time x Group interaction will be the primary focus, and we aim to evaluate 1) the extent to which the primary endpoint differs between Baseline and Week 1, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Primary | Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete) | Discrete negative emotion items: depressed, angry, frustrated, and worried. Negative affect will be assessed by asking participants to rate the intensity of four discrete negative emotions (depressed, angry, frustrated, and worried) on a 5-point Likert scale from 1-5 ("Very slightly or not at all" to "Extremely") and averaging those discrete items. Negative Affect scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Lower Negative Affect scores represent lower levels of negative affect. A separate set of LMERs will be utilized for each primary endpoint (aggregated averages of momentary negative affect), with a primary LMER estimating the difference between Baseline and Week 1. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the primary endpoint differs between Baseline and Week 1, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Primary | Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete) | Pain catastrophizing will be assessed with three items taken from the Pain Catastrophizing Scale that have been specifically validated for use in Ecological Momentary Assessment (EMA) studies of patients with chronic pain. Items will be administered via EMA and scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Each item is on a 5-point Likert scale (ranging from 0, "Not at all", to 4, "All the time"). Higher scores on each of these items indicates increased pain catastrophizing. A separate set of LMERs will be utilized for each primary endpoint (aggregated averages of momentary pain catastrophizing), with a primary LMER estimating the difference between Baseline and Week 1. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the primary endpoint differs between Baseline and Week 1, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Primary | Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) | Baseline, 1-week follow-up | Positive Affective Pain Inhibition will be assessed using quantitative sensory testing at baseline, 1-week post-drug-administration, and 1-month post-drug-administration. Positive affective pain inhibition is measured as the difference in pain ratings to noxious stimuli administered during the presentation of positive/rewarding stimuli relative to neutral or negative stimuli. A separate set of LMERs will be utilized for each primary endpoint (index of Positive Affective Pain Inhibition), with a primary LMER estimating the difference between Baseline and Week 1. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the primary endpoint differs between Baseline and Week 1, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Secondary | Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA 1-month Post-drug (7 days leading up to 1-month follow-up) relative to Baseline (beginning the day after baseline visit is complete) | Discrete positive affect items: joy, love, hope, contentment. Positive affect will be assessed by asking participants to rate the intensity of four discrete positive emotions (joy, love, hope, contentment) on a 5-point Likert scale from 1-5 ("Very slightly or not at all" to "Extremely") and averaging discrete items. Positive Affect scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Higher Positive Affect scores represent higher levels of positive affect. A separate set of LMERs will be utilized for each endpoint (aggregated averages of momentary positive affect), with a secondary LMER estimating the difference between Baseline and 1-Month. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the secondary endpoint differs between Baseline and 1-Month, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Secondary | Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA 1-month Post-drug (7 days leading up to 1-month follow-up) relative to Baseline (beginning the day after baseline visit is complete) | Discrete negative emotion items: depressed, angry, frustrated, and worried. Negative affect will be assessed by asking participants to rate the intensity of four discrete negative emotions (depressed, angry, frustrated, and worried) on a 5-point Likert scale from 1-5 ("Very slightly or not at all" to "Extremely") and averaging discrete items. Negative Affect scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Lower Negative Affect scores represent lower levels of negative affect. A separate set of LMERs will be utilized for each endpoint (aggregated averages of momentary negative affect), with a secondary LMER estimating the difference between Baseline and 1-Month. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the secondary endpoint differs between Baseline and 1-Month, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Secondary | Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) | 7-day period of EMA 1-month Post-drug (7 days leading up to 1-month follow-up) relative to Baseline (beginning the day after baseline visit is complete) | Pain catastrophizing will be assessed with three items taken from the Pain Catastrophizing Scale that have been specifically validated for use in Ecological Momentary Assessment (EMA) studies of patients with chronic pain. Items will be administered via EMA and scores will be aggregated over 7-day EMA periods at baseline, post-session, and 1-month follow-up. Each item is on a 5-point Likert scale (ranging from 0, "Not at all", to 4, "All the time"). Higher scores on each of these items indicates increased pain catastrophizing. A separate set of LMERs will be utilized for each endpoint (aggregated averages of momentary pain catastrophizing), with a secondary LMER estimating the difference between Baseline and 1-Month. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the secondary endpoint differs between Baseline and 1-Month, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Secondary | Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) | Baseline, 1-Month follow-up | Positive Affective Pain Inhibition will be assessed using quantitative sensory testing at baseline, 1-week post-drug-administration, and 1-month post-drug-administration. Positive affective pain inhibition is measured as the difference in pain ratings to noxious stimuli administered during the presentation of positive/rewarding stimuli relative to neutral or negative stimuli. A separate set of LMERs will be utilized for each endpoint (index of Positive Affective Pain Inhibition), with a secondary LMER estimating the difference between Baseline and 1-Month. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the secondary endpoint differs between Baseline and 1-Month, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Other | Pain as assessed by discrete pain items assessed via EMA | 7-day periods of EMA at 1-week follow-up and 1-month follow-up, each relative to Baseline | Discrete pain items include 'Rate your current level of pain' and 'Over the past hour: Rate the worst pain you experienced.' These items will be assessed multiple times daily during each EMA items. These items will be averaged over each EMA burst to determine pain levels over the course of trial participant. A separate set of LMERs will be utilized for each endpoint (aggregated averages of momentary pain ratings), with LMERs estimating the differences between Baseline and 1-Week as well as 1-Month. The Time x Group interaction will be the primary focus of interest, and we aim to evaluate 1) the extent to which the endpoint differs between Baseline and 1-Week as well as 1-Month, and 2) the extent to which that difference varies between the Psilocybin and Control groups. |
| Other | Dynamic association between affect and pain using micro-longitudinal EMA data of affective variables (positive, negative affect outcomes) and pain outcomes | 7-day periods of EMA at: Baseline (beginning the day after baseline visit is complete), Post-drug Session (beginning the day after drug session), and 1-month follow-up (the seven days leading up to the 1-month follow-up visit) | Our secondary analytic strategy will focus on the dynamic association between affect and pain using the micro-longitudinal EMA data, in which the EMA data is organized hierarchically with Waves (Baseline, 1-week, 1-month) nested within People, Days nested within Waves, and Momentary Observations (up to four) nested within Days. For each EMA wave (Baseline, 1-week, and 1-month), we will utilize separate LMERs to evaluate the momentary (i) concurrent and (ii) lagged associations between affective variables and pain. In each LMER, person-mean centered day-level affective variables and Group (Psilocybin vs. Methylphenidate) will be included as fixed effects; day-level intercept and participant-level intercept will be included as random effects. Results from these LMERs will also allow us to evaluate the extent to which the momentary concurrent/lagged associations differ by group at each EMA wave. |
| Other | Changes in mood as measured by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X). | 7-day periods of EMA at: Baseline (beginning the day after baseline visit is complete), Post-drug Session (beginning the day after drug session), and 1-month follow-up (the seven days leading up to the 1-month follow-up visit) | The selected, discrete positive and negative affect items described in Primary Outcome 1 will be supplemented by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X) and measured via Ecological Momentary Assessment (EMA). |
| Other | Changes in self-reported Pain Impact as measured by Pain intensity (P), interference with Enjoyment of life (E), and interference with General activity (G) Scale (PEG) | 7-day periods of EMA at: Baseline (beginning the day after baseline visit is complete), Post-drug Session (beginning the day after drug session), and 1-month follow-up (the seven days leading up to the 1-month follow-up visit) | Pain impact will be assessed with the Pain average, interference with Enjoyment of life, and interference with General activity (PEG), which will be assessed with EMA over the course of three distinct 7-day periods at baseline, immediately following drug session, and leading up to 1-month follow-up to permit time-varying analyses of the associations of affective mechanisms with pain and function. The PEG is a three-item measure scored, with each item rated on a scale of 0-10. Higher scores indicate higher levels of pain intensity or higher levels of interference of interference with enjoyment/general activity, depending on the item. Overall, higher scores indicate higher levels of pain impact. |
| Other | Changes in Pressure Pain Threshold (Quantitative Sensory Testing) | Baseline, 1-week follow-up, 1-month follow-up | An electronic algometer with a 1cm2 hard rubber probe will be used to assess responses to noxious mechanical pressure, according to standard procedures. Pressure at the site is gradually increased at a steady rate and stopped when the subject indicates the stimulus is first perceived as painful and/or tolerance is reached. |
| Other | Changes in Conditioned Pain Modulation (Quantitative Sensory Testing) | Baseline, 1-week follow-up, 1-month follow-up | The thermal (primary outcome for determination of painful stimuli, as in Primary Outcome 3) and pressure (secondary outcome for pain testing, described in Outcome 16) stimuli may be presented together or in succession to assess conditioned pain modulation. |
| Other | Chronic Pain Exacerbation as measured by the Graded Chronic Pain Scale- Revised (GCPS-R) | Baseline, 1-week follow-up, 1-month follow-up | Chronic Pain Exacerbation will be assessed via the Graded Chronic Pain Scale- Revised (GCPS-R). This scale probes the frequency of pain and the degree to which it interferes with daily life and work activities. Responding that the pain interferes more frequently results in a higher a grade. The GCPS-R is graded from 0 (Chronic Pain Absent) to 3 (High-Impact Chronic Pain). |
| Other | Changes in neuropathic pain features as assessed by the painDETECT questionnaire (PDQ) | Baseline, 1-week follow-up, 1-month follow-up | Neuropathic pain features will be assessed with the painDETECT questionnaire (PDQ). The PDQ comprises 12 items. The resulting total score classifies pain into three groups: a score \> 18 indicates that the presence of a predominant neuropathic pain component is likely, a score of 13 to 18 is considered uncertain, and a score \< 13 indicates that a neuropathic pain component is not likely present. |
| Other | Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI) | Baseline, 1-week follow-up, 1-month follow-up | CLBP-related disability will be assessed with the Oswestry Disability Index (ODI). The ODI is a self-administered questionnaire divided into ten sections/items designed to assess limitations of various activities of daily living. Patients are asked to select which statement they agree with most on each item/section of the index, and each section is scored on a 0-5 scale, 5 representing the greatest disability. Summed scores range from 0-50, with 0 representing "no disability" and 50 representing "completely disabled". |
| Other | Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS) | Baseline, 1-week follow-up, 1-month follow-up | Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale (DERS). This is self-report scale that asks respondents how they relate to their emotions. Items are rated on a scale of 1 ("almost never") to 5 ("almost always"). Higher scores indicate more difficulty in emotion regulation. |
| Other | Pain intensity and related dimensions of health (i.e., sleep) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.0). | Baseline, 1-week follow-up, 1-month follow-up | The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). |
| Other | Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale (PIPS) | Baseline, 1-week follow-up, 1-month follow-up | Psychological Inflexibility in Pain. The PIPS is a 12-item questionnaire that aims at measuring psychological inflexibility with two subscales, Avoidance of Pain (Avoidance) and Cognitive Fusion with Pain (Fusion). The PIPS consists of 12 items rated on a 7-point scale from 1 (never true) to 7 (always true). Higher scores indicate greater levels of psychological inflexibility. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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