Trial · NCT07087015
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 | Clinician-Administered PTSD Scale (CAPS-5) scores | Baseline (1 month before the block), 30 and 90 days post-block. | CAPS-5 score is used to establish severity of PTSD. It is a 30-item structured interview that assesses the 20 DSM-5 PTSD symptoms, as well as associated features, the onset and duration of symptoms, global severity, symptom impact, improvement in symptoms, and a validity check. The resulting values range from 0 to 80, with the higher scores indicating worse PTSD symptom severity. |
| Secondary | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) scores | Baseline (1 month before the block), then 7, 14, 30 and 90 days post-block | PCL-5 is used to establish severity of self-rated symptoms of PTSD. It is a 20-item self-report measure that assesses the 20 DSM-5 PTSD symptoms. The resulting valuea range from 0 to 80, with the higher scores indicating worse PTSD symptom severity. |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | 2 weeks before the block and 2 weeks post-block | A 9-item, self-administered instrument used to screen for the presence and severity of depression. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depressive symptom severity. |
| Secondary | State and Trait Anxiety Scale (STAI) | 2 weeks before the block and 2 weeks post-block | A 40-item self-report questionnaire designed to assess two types of anxiety: state anxiety (temporary condition in response to specific situations) and trait anxiety (general tendency to respond with anxiety). Each subscale (20 items each) is scored on a 4-point Likert scale, with higher scores indicating greater anxiety. |
| Secondary | Generalized Anxiety Disorder scale (GAD-7) | 2 weeks before the block and 2 weeks post-block | A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), yielding a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety. |
| Secondary | Positive and Negative Affect Schedule (PANAS) | 2 weeks before the block and 2 weeks post-block | A 20-item self-report questionnaire that measures two distinct dimensions of affect: Positive Affect (PA) and Negative Affect (NA). Respondents rate the extent to which they have experienced various emotions over a specified time frame using a 5-point Likert scale (1 = very slightly or not at all; 5 = extremely). Each subscale consists of 10 items, with higher scores indicating greater positive or negative affect. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 2 weeks before the block and 2 weeks post-block | A self-rated questionnaire that assesses sleep quality and disturbances over a 1-month period. It consists of 19 items generating seven component scores (e.g., sleep latency, duration, disturbances), which are summed to yield a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
| Secondary | The Satisfaction With Life Scale | 2 weeks before the block and 2 weeks post-block | A 5-item self-report instrument designed to assess global cognitive judgments of one's overall life satisfaction. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), producing a total score ranging from 5 to 35. Higher scores indicate greater life satisfaction. |
| Secondary | Scales of Psychological Well-Being | 2 weeks before the block and 2 weeks post-block | A multidimensional self-report instrument designed to assess six key aspects of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Versions range from 18 to 84 items, with each dimension measured via Likert-scale items. Higher scores reflect greater well-being in each domain. |
| Secondary | Peace of Mind Scale | 2 weeks before the block and 2 weeks post-block | A brief self-report measure assessing an individual's inner peace and emotional calmness. The scale typically consists of 5 items rated on a 5-point Likert scale (1 = not at all; 5 = extremely true), with higher scores indicating a greater sense of peace and psychological stability. |
| Secondary | The Emotion Regulation Questionnaire Short Form | 2 weeks before the block and 2 weeks post-block | A 6-item self-report instrument that assesses two emotion regulation strategies: cognitive reappraisal (4 items) and expressive suppression (2 items). Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with higher scores indicating greater use of the respective strategy. |
| Secondary | Harmony in Life Scale | 2 weeks before the block and 2 weeks post-block | A 5-item self-report measure that assesses an individual's perceived harmony and balance in life. Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with higher scores indicating greater harmony in life. |
| Secondary | The Perth Alexithymia Questionnaire Short Form | 2 weeks before the block and 2 weeks post-block | A 24-item self-report questionnaire designed to assess alexithymia, characterized by difficulties in identifying, describing, and processing emotions. The PAQ measures both general alexithymia and its specific facets across different emotional valences (positive and negative). Items are rated on a 7-point Likert scale, with higher scores indicating greater alexithymic traits. |
| Secondary | Stanford Expectations of Treatment Scale (SETS) | 2 weeks before the block and 2 weeks post-block | A brief self-report measure assessing patients' positive and negative expectations regarding treatment outcomes. The scale consists of 10 items rated on a 5-point Likert scale, capturing the extent of optimism or pessimism about the effectiveness of a given treatment. Higher scores reflect stronger positive expectations. |
| Secondary | Columbia Suicidality Severity Rating Scale (CSSRS) Short Screen | 3 weeks before the block and days 1, 7, 14, 30, 90 post-block | A brief clinician- or self-administered screening tool designed to assess the severity and immediacy of suicidal ideation and behavior. The short screen includes key items to quickly identify individuals at risk by evaluating recent suicidal thoughts, plans, and attempts. While the full C-SSRS has scoring and severity ratings, the short screen's primary use is as a binary screener (presence/absence of risk). |
| Secondary | Adverse events | Days 1, 7, 14, 30, 90 post-block | The occurrence of adverse events will be collected. |
| Secondary | Sleep and Dream Log | Daily starting from 2 weeks before the block and ending at 2 weeks post-block | A self-reported daily diary in which participants record details about their sleep patterns and dream experiences. Typical entries include bedtime, wake time, sleep latency, number and duration of awakenings, subjective sleep quality, and dream recall or content. The log provides qualitative and quantitative data on sleep behavior and dream activity over the monitoring period. |
| Secondary | Daily Mood Questionnaire | Daily starting from 2 weeks before the block and ending at 2 weeks post-block | A brief self-report instrument completed daily to assess fluctuations in mood states. Participants rate their current mood or specific affective dimensions (e.g., happiness, sadness, anxiety, irritability) using Likert-type scales. The questionnaire captures short-term mood variability and overall emotional well-being throughout the study period. |
| Secondary | Home Sleep Monitoring | Daily starting from 2 weeks before the block and ending at 2 weeks post-block | Objective sleep data collected at home using the Muse EEG headband, a wearable device that records brainwave activity to assess sleep architecture and quality. The device measures parameters such as sleep onset latency, total sleep time, sleep stages (e.g., REM, deep sleep), and awakenings. Data are analyzed to provide quantitative metrics of sleep patterns in a naturalistic environment. |
| Secondary | Home-Based Polysomnography (PSG) | Three days before the block and 3 days post-block | Participants will come to the lab in the evening, where study staff will attach a portable PSG device. Participants will then return home via taxi and sleep while wearing the device. The next morning, they will return to the lab via taxi, where the study staff will remove the PSG. |
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.
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