Trial · NCT07217340
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study Retention | 7 weeks (baseline to post-intervention) | Study retention as an outcome measure will be considered positive if ≥65% of participants complete data collection at both pre- and post-intervention. |
| Primary | Acceptability of the Intervention | 7 weeks (throughout the intervention period) | Acceptability will be assessed through composite measures of adherence to different elements of the intervention. The intervention will be considered acceptable if at least 70% of participants attend a minimum of five sessions. Adherence to supportive practices (dream journaling and online SHEP engagement) will also be assessed. These components will be considered acceptable if ≥75% of participants engage in Virtual Reality at a rate of ≥65%. |
| Primary | Tolerability of Dream Yoga Virtual Reality | 7 weeks (after each VR session) | Tolerability will be assessed using the Simulator Sickness Questionnaire (SSQ), which measures nausea, oculomotor strain, and disorientation. The intervention will be considered tolerable if fewer than 20% of participants report severe simulator sickness or withdraw due to VR-related adverse effects. Additional safety will be monitored through adverse event logs. |
| Primary | Study Retention | 7 weeks (baseline to post-intervention) | Feasibility will be assessed through study retention, defined as ≥65% of participants completing data collection at both pre- and post-intervention. |
| Secondary | Frequency of Lucid Dreaming | 7 weeks | Lucidity will be assessed with a composite of questionnaires at week 1 and measuring changes at week 7 and using self-reports of lucid dreams recorded in daily dream journals and/or nightly reports during the 7-week intervention. The outcome will be positive if one third of participants experience at least one lucid dream. Self-report Questionnaires: 1. Lucid Dreaming Skills Questionnaire (LUSK) 2. Lucid Dream Control-Specific Experiences (LDC-SE) |
| Secondary | Acceptability of the intervention | 7 weeks | Acceptability will also be measured with the Acceptability of Intervention Measure (AIM), a 4-item validated scale (1-5 Likert). The intervention will be considered acceptable if the mean AIM score is ≥4. |
| Secondary | Feasibility of the Intervention | 7 Week | Feasibility will be measured with the Feasibility of Intervention Measure (FIM), a 4-item validated scale (1-5 Likert). The intervention will be considered feasible if the mean FIM score is ≥4 ("agree" or "completely agree"). |
| Other | Change in Cognitive Flexibility Scale Score | 7 weeks (baseline to post-intervention) | Self-report measure assessing perceived ability to shift between thoughts and adapt to changing situations. |
| Other | Change in Generalized Anxiety Disorder Scale (GAD-7) Score | 7 weeks (baseline to post-intervention) | The Generalized Anxiety Disorder Scale - 7 item (GAD-7) is a self-report questionnaire used to assess anxiety symptoms over the past two weeks. Each item is rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
| Other | Self-referential Processing: Composite od Subjective and Neural Markers | 7 weeks | Self-referential processing will be assessed using a composite of subjective and neurophysiological measures. Subjective measures include the Mindful Attention Awareness Scale (MAAS), the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), and the Nondual Awareness Dimensional Assessment (NADA) and Beck Cognitive Insight Scale. Neural activity associated with self-referential processing will be indexed by frontal midline theta power (4-7 Hz) during resting-state EEG. Increased frontal midline theta has been associated with internal attention, cognitive control, and self-related processing. A composite score may be computed via z-score standardization or used in exploratory correlation analyses. Higher mindfulness and nondual awareness scores, together with increased frontal midline theta, will be interpreted as indicators of enhanced self-referential regulation. |
| Other | Change in Probabilistic Reversal Learning Task Performance | 7 weeks | Behavioral measure of adaptive learning and response shifting following feedback. Accuracy rate (proportion correct) and/or number of reversal errors will be assessed. |
| Other | Change in Stroop Task Performance | 7 weeks | Behavioral measure of cognitive control and interference resolution. Reaction time in milliseconds and/or accuracy will be assessed. |
| Other | Change in PROMIS Anxiety Questionnaire Score | 7 weeks (baseline to post-intervention) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire is a self-report measure assessing anxiety symptoms. It generates a T-score standardized to the general U.S. population (mean = 50, SD = 10). Higher scores indicate more severe anxiety symptoms. |
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.
For software
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