Trial · NCT04448808
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and intensity of nightmares | 10 weeks | Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares. |
| Secondary | Change from baseline of the frequency and intensity of nightmares | 1, 2, 3, 4,6 and 8 weeks | Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. |
| Secondary | Change from baseline of the CAPS-5 total score | 6 and 10 weeks | Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) |
| Secondary | Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD | 6 and 10 weeks | Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms) |
| Secondary | Change from baseline of the Montgomery-Åsberg Depression Rating Scale | 4 and 10 weeks | Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms) |
| Secondary | Weekly mean of change from baseline of daily total sleep time | during 10 weeks | Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries |
| Secondary | Weekly mean of change from baseline of the patients sleep onset latency at night | during 10 weeks | Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries |
| Secondary | Weekly mean of change from baseline of the patients recuperation of night sleep | during 10 weeks | Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), assessed with sleep diaries |
| Secondary | Weekly mean of change from baseline of the patients time awake at night | during 10 weeks | Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries |
| Secondary | Weekly mean of change from baseline of the patients number of nightmares last night | during 10 weeks | Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries |
| Secondary | Weekly mean of change from baseline of the patients intensity of nightmares | during 10 weeks | Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries |
| Secondary | Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 | 6 and 10 weeks | Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5) |
| Secondary | Change from baseline of the Borderline Symptom List 23 | 6 and 10 weeks | Change from baseline of the Borderline Symptom List 23 (BSL-23) score |
| Secondary | Change from baseline of the Health-Related Quality of Life | 6 and 10 weeks | Change from baseline of the Health-Related Quality of Life (EQ-5D) score |
| Secondary | Overall patients status measured by the Patient Global Impression of Change | 6 and 10 weeks | Overall patients status measured by the Patient Global Impression of Change (PGIC) |
| Secondary | Change from baseline of the Social and Occupational Functioning Assessment Scale | 6 and 10 weeks | Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS) |
| Secondary | Change from baseline of the Pittsburgh Sleep Quality Index | 6 and 10 weeks | Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) |
| Secondary | Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire | 6 and 10 weeks | Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) |
| Secondary | Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist | 6 and 10 weeks and Follow- Up Visit 9 | Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC) |
| Secondary | Responder analysis: proportion of patients showing improvement in nightmares | 10 weeks | Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 ≥50% assessed at the end of treatment |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04448808/registered