Trial · NCT07301632
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary outcome of this pilot trial is to determine feasibility of a large-scale, multi-center trial. | 16 weeks | Average Monthly recruitment of \>1 participant per center means that the full trial should meet recruitment requirements within 12 months. |
| Primary | Secondary feasibility outcome | 16 weeks | Data completion rate (of primary clinical outcome)≥ 80% |
| Primary | Participant Retention | 16 weeks | Retention of ≥80% of participants at the reported primary outcome point of 16 weeks after the experimental session should minimize attrition bias in the definitive trial's primary outcome data (e.g. withdrawal due to side-effects) |
| Primary | Blinding | 16 weeks | Blinding Integrity (≤80% of participants in both arms correctly guess their treatment allocation (Note: 50% of participants would be expected to correctly guess treatment allocation due to chance alone) |
| Primary | Adverse Events | 16 weeks | ≤3 serious drug-related adverse events |
| Primary | Secondary Feasibility Outcome | 16 weeks | identification of patient, clinician and researcher-identified trial barriers using qualitative methods (e.g. interviews at the end of the study with participants who provides consent ) |
| Secondary | The Patient-Reported Outcomes Measurement Information System (PROMIS) pain Intensity, Pain Interference and Physical Function Scale | Week 1, Week 7, Week 11 and Week 16 | In the past 7 days patients to rate their pain on average- 0 scale-indicates No pain and 10 scale- indicates Worst imaginable pain |
| Secondary | Patient Health Questionnaire (PHQ-9) | Week 1, Week 7, Week 11 and Week 16 | Over the last 2 weeks how often the patient has been bothered by daily activities on a scale of 0 to 3. 0 (Not at all) and 3 (Nearly every day) |
| Secondary | Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire | Week 1, Week 7, Week 11 and Week 16 | Over the last 2 weeks, how often patients have been bothered by anxiety on a scale of 0 to 3. 0 equals Not at all and 3 equals Nearly every day |
| Secondary | The Post traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual for Mental Disorder-5 (PCL-5) | Week 1, Week 7, Week 11 and Week 16 | Over the past month, how patients were bothered by internal and external feelings like stress, negativity etc. This is measured on a scale of 0 (Not at all) to 4 (Extremely) |
| Secondary | Health Questionnaire (EQ-5D-5L) | Week 1, Week 7, Week 11 and Week 16 | Patients to describe how their health is affected in terms of mobility, self-care, Usual activities like (work, study, family), Pain/Discomfort, Anxiety/Depression on a scale of 0( Worst health you can imagine) to 100 (Best health you can imagine) |
| Secondary | The Patient Global Impression of Change Scale (PGIC) | Week 7, Week 11 and Week 16 | This questionnaire measures how the patient impression changed before being enrolled in the study. Measured in a scale of 1 (Very much Improved) to 7 ( Very Much Worse) |
| Secondary | The Toronto Side Effect Scale (TSES) | Week 7, Week 11 and Week 16 | This questionnaire measures patient's symptoms in the last two weeks for Agitation, tremor, twitching etc in terms of frequency and Severity in a scale of 1 (Never) to 5 (Every day) |
| Secondary | STAR-P | Week 7, Week 11 and Week 16 | This questionnaire measures patient's perception and attitude regarding the clinician on a scale of 0 (Never) to 4 (Always) |
| Secondary | Subjective Drug Effects (VAS) | Week 6 | On a scale of 0 (Not at all) to 10 (Extremely) patients to describe their experience during intervention session regarding the subjective drug effects |
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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GET https://conductscience.org/api/trials/v1/NCT07301632/registered