Trial · NCT05360953
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of frequency and intensity of nightmares | 10 weeks | Change of Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8, from baseline until directly after last intervention. A lower score indicates less frequent and/or intense nightmares. |
| Secondary | Change of frequency and intensity of nightmares | 1,2,3,4,5,6 and 8 weeks | Change of Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8, from baseline until directly after last intervention. A lower score indicates less frequent and/or intense nightmares. |
| Secondary | Change from baseline of the CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) total score | 6 and 10 weeks | Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week) (minimum value = 0; maximum value = 80; higher scores indicate higher PTSD symptom severity) |
| 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); (score = 0-21 point, 0 = no difficulty; 21 = severe difficulty in all areas) |
| Secondary | Change from baseline of the -Montgomery Asberg Depression Rating Scale (MDRS) | 6 and 10 weeks | Change from baseline of the MADRS (scores: 0 - 60; 0 - 6 = no depression; 7 - 19 = light depression; 20 - 34 = moderate depression; \> 34 severe depression) |
| 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 (in minutes), assessed with sleep diaries | 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 PCL-5 PTSD Checklist for DSM-5; Score can range from 0-80 (higher scores indicate a higher PTSD symptom severity) Score (0 - 80; higher scores indicating higher chance of a possible PTSD diagnosis) |
| Secondary | Change from baseline of the Borderline Symptom List 23 (BSL-23) | 6 and 10 weeks | Change from baseline of the BSL-23 score (Scores can range from 0 to 92; higher scores indicate higher Borderline symptom severity) Scores: 0 - 4 (0 = no Borderline Symptoms; 4 = severe borderline symptoms) |
| Secondary | Change from baseline of the Health-Related Quality of Life (EQ-5D) | 6 and 10 weeks | Change from baseline of the EQ-5D score (score can range from 0-100; with higher scores indicating a better Health Related Quality of Life) Scores = 1-5 (1 = no problems; 5 = extreme problems) |
| Secondary | Overall patients status measured by the Patient Global Impression of Change (PGIC) | 6 and 10 weeks | Overall patients status measured by the PGIC (Scores can range from 0 - 7; with higher scores indicating higher improvement) score: 0 - 7 (0 = disease deterioration; 7 = disease improvement) |
| 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); Scores can range from 1 - 100, with higher scores indicating better social and occupational functioning |
| Secondary | Change from baseline of the Pittsburgh Sleep Quality Index (PSQI) | 6 and 10 weeks | Change from baseline of the PSQI; Scores can range from 0 to 21, with higher scores indicating lower sleep quality Scores : 0 - 21, lower scores denote a healthier sleep quality |
| Secondary | Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ) | 6 and 10 weeks | Change from baseline of symptoms of ITQ, dimensional scores can range from 0 - 24, with higher scores indicating highter PTSD symptom severity Categorical Scoring: For PTSD items, endorsement of a symptom or functional impairment item is defined as a score of 2 or greater. The diagnosis of PTSD is indicated based on the following criteria: * Question 1 or 2 = one or more items endorsed (re-experiencing) * Question 3 or 4 = one or more items endorsed (avoidance) * Question 5 or 6 = one or more items endorsed (sense of current threat) * Question 7, 8 or 9 = one or more items endorsed (PTSD functional impairment) |
| 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 CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-IV (CAPS-IV B2) ≥50% assessed at the end of treatment Score: 0 - 8 (higher scores indicate higher frequency and severity of nightmares) |
| Secondary | Remitter analysis: proportion of patients showing full remission of nightmares | 10 weeks | Remitter analysis: proportion of patients showing full remission of nightmares defined as CLINICIAN-ADMINISTERED PTSD SCALE FOR DSM-IV (CAPS-IV B2) = 0, assessed at the end of treatment; 0 = no nightmares (score 0 - 8; higher scores indicate higher frequency and severity of nightmares)) |
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/NCT05360953/registered