Trial · NCT04951076
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks,12 weeks | The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms. |
| Secondary | Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms. |
| Secondary | Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms. |
| Secondary | Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms. |
| Secondary | Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms. |
| Secondary | Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes. |
| Secondary | Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms. |
| Secondary | Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms. |
| Secondary | Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | Change from Baseline on patient-reported global functioning The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms. |
| Secondary | Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks, 12 weeks | The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity. |
| Secondary | Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks | Baseline, 4 weeks, 8 weeks,12 weeks | The SDS is a rating scale designed to measure impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on a scale of 0 (not at all) to 10 (extremely), for a total score of 0 to 30, with a higher score indicating a higher degree of impairment. |
| Secondary | Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks | Baseline, 12 weeks | The PCL-5 is a 20-item self-report assessment of the 20 DSM-5 symptoms of PTSD. Each symptom is rated on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 80, with higher scores indicating greater severity of PTSD 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04951076/registered