Trial · NCT06117306
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician-rated PTSD symptoms | Baseline - 4-months post-treatment | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity. |
| Secondary | Self-reported PTSD symptoms | Baseline - 4-months post-treatment | The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to symptoms on a five-point Likert-type scale (1=Not at all to 5=Extremely). Total scores range from 0 to 80, with higher scores indicating more severe PTSD symptoms. |
| Secondary | Depressive Symptoms | Baseline - 4-months post-treatment | The Patient Health Questionnaire 9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. The PHQ-9 screens for major depression, with a score of 10 or above indicative of a possible major depressive episode, and it provides a measure of severity of these symptoms. |
| Secondary | Functioning | Baseline - 4-months post-treatment | The Brief Inventory of Psychosocial Functioning (B-IPF) is a brief version of the Inventory of Psychosocial Functioning (IPF) that measures functioning impairment across seven domains: intimate relationships, family and parenting, friendships, work, socializing, education, and self-care over the past 30 days. Total scores, ranging from 0 to 100, are calculated as the sum score divided by the total possible score multiplied by 100, with higher scores indicating greater impairment in functioning. |
| Secondary | Sleep | Baseline - 4-months post-treatment | The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality over the past 1-month using 19 items in a self-report questionnaire format. The scale has seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Items are rated on a combination of Likert scales from 0 to 3 and open- ended questions that are later converted to scaled scores. Higher total scores indicate greater sleep disturbance. |
| Secondary | Safety/Suicidality | Baseline - 4-months post-treatment | The C-SSRS is a clinician-administered measure of suicidal behavior devised to detect potential suicidal thoughts or behaviors during a clinical trial. It consists of a Baseline version and a Since Last Visit version that assess suicidal ideation, ideation intensity, and behavior. |
| Secondary | Sexual Functioning | Baseline - 4-months post-treatment | The CSFQ-14 is a 14-item self-report scale that evaluates sexual functioning. The measure has five subscales: pleasure, desire/frequency, desire/interest, arousal/excitement, and orgasm/completion. All items are scored on 5-point scales with varying response options. Higher total scores indicate better sexual functioning. The CSFQ-14 has corresponding assigned-male-at-birth and assigned-female-at-birth versions. |
| Secondary | Moral Injury | Baseline - 4-months post-treatment | The MIDS is a two-part self-report measure that examines potentially morally injurious events (PMIEs) exposure and moral injury symptoms in the past month. The first part of the scale uses 6 items to measure exposure to and bothersomeness of PMIEs through a 5-point Likert scale (0=Not at all to 4=Extremely). The second part of the scale includes a series of open-ended questions to select and describe the most distressing PMIE. Respondents then complete 18 items that are scored on 5-point Likert scales to indicate their cognitive, emotional, behavioral, social, and religious or spiritual reactions to the PMIE that they find the most distressing. Higher summed score indicates more severe moral distress. |
| Secondary | Adverse Childhood Experiences | Baseline | Measured using the Adverse Childhood Events Scale (ACES). The ACES is a 10-item self-report survey that asks about childhood stress. Participants indicate exposure to different kinds of abuse with yes/no responses, and answer "1" if the abuse happened often. Higher scores indicate greater exposure to childhood stressors. |
| Secondary | Posttraumatic Growth | Baseline - 4-months post-treatment | Measured using the Posttraumatic Growth Inventory (PTGI). The PTGI is a 21-item self-report measure that asks about level of posttraumatic growth across 5 subscales in adults who have experienced trauma. Participants respond using a 6-point Likert scale (1=I did not experience this change as a result of my crisis, to 6=I experienced this change to a very great degree as a result of my crisis).Total scores range from 1-126. |
| Secondary | Anger | Baseline - 4-months post-treatment | The STAXI-2 is a 57-item self-report measure that assesses the respondent's experience, expression, and control of anger. The measure includes six scales; for the purpose of this study, only the state anger state anger (i.e., the intensity of anger at the time of completing the scale; 15 items) and trait anger (i.e., whether the person has an overall angry temperament; 10 items) scales will be used, for a total of 25 items. All items are rated on a scale from 1 (Almost never) to 4 (Almost always). Both scales are scored by summing responses to each item, with higher scores indicating higher state and/or trait anger. Ranges are 15-60 for the state scale and 10-40 for the trait scale. |
| Secondary | Well Being | Baseline - 4-months post-treatment | Measured using the Well-Being Signs (WBS). The WBS is a 3-item self-report measure examining psychosocial well-being. All items are rated on a scale from 0 to 10. An average score is calculated based on the ratings for each question. Higher scores indicate better psychosocial well-being. |
| Secondary | Positive and Negative Affect | Baseline - 4-months post-treatment | Measured using the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure of positive affect and negative affect, with a 10-item positive affect subscale and 10-item negative affect subscale. Items are rated on a scale from 1 (very slightly or not at all) to 5 (extremely). Higher scores on each subscale indicate more positive and negative affect respectively. |
| Other | Satisfaction with Care | 1 week post-treatment | The Client Satisfaction Questionnaire - 8-item version (CSQ-8) is an 8-item survey of patient satisfaction with healthcare or services that they are receiving. Items are rated on Likert scales from 0 to 3 with varying response options based on the question. Questions address varying aspects of satisfaction with care. Higher scores indicate higher satisfaction. |
| Other | Acceptability of Care | 1 week post-treatment | Audiotaped Qualitative Interview |
| Other | Treatment Expectations | Baseline, Visit 3 | Measured using the Stanford Expectations of Treatment Scale (SETS). The SETS is a 10-item self-report questionnaire that assesses a patient's feelings about their upcoming treatment. The first 6 items are rated on a 7-point Likert scale (1=strongly disagree, to 7=strongly agree). Items 7-9 are open-ended. Item 10 is a yes/no response. The scale yields a score for positive expectancy and negative expectancy. |
| Other | Trauma Exposure | Baseline | Measured using the Life Events Checklist for DSM-5 (LEC-5). The LEC-5 is a 17-item self-report survey that asks about exposure to potentially traumatic events. Participants indicate the type of exposure for each event (Happened to me, Witnessed it, Learned about it, Part of my job, Not sure, Doesn't apply). |
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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