Trial · NCT07897903
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment retention/adherence | At the beginning of each session (all 12 weeks) | Proportion of enrolled participants who complete the intervention (participants retention/adherance \>= 75%). |
| Primary | Recruitment rate | Recruitment period | Participants enrolled |
| Primary | Mean number of sessions attended and attrition rate | At the beginning of each session (all 12 weeks) | |
| Primary | Client Satisfaction Questionnaire | Immediately after the intervention (week 12) | Acceptability will be assessed after the intervention using a participant satisfaction questionnaire (CSQ-8). The questionnaire will evaluate participants' perceived usefulness, relevance, comprehensibility, and overall satisfaction with the intervention. 8 items rated from 1 to 4. Total score ranges from 8 to 32. Higher scores indicate greater satisfaction and acceptability (better outcome). |
| Secondary | Change in PTSD/CPTSD symptoms (I) at 12 weeks and 6 months | Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up | PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013). * 20 items rated from 0 (not at all) to 4 (extremely). Total score ranges from 0 to 80. * Higher scores indicate a worse outcome (more severe symptoms). |
| Secondary | Change in PTSD/CPTSD symptoms (II) at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | International Trauma Questionnaire (ITQ; Cloitre et al., 2018). * 12 symptom items (6 PTSD, 6 Disturbances in Self-Organization) rated from 0 (not at all) to 4 (extremely). Symptom total score ranges from 0 to 48 (each of the two sets of items from 0 to 24). * Higher scores indicate a worse outcome (more severe symptoms). |
| Secondary | Change in PTSD/CPTSD symptoms (III) at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Impact of Trauma Questionnaire (Spanish questionnaire; "Cuestionario de Impacto del Trauma", CIT; Crespo, González-Ordi, Gómez-Gutiérrez, Santamaría, 2020). * 180 items related to different scales on PTSD symptomatology and comorbid symptomatology rated from 1 (never) to 5 (always). * Higher scores mean worse outcome (more severe symptoms). |
| Secondary | Change from psychopathological symptoms at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Symptom Assessment-45 Questionnaire (SA-45; Davison et al., 1997), a brief version of the Symptom Checklist-90-Revised (SCL-90-R). * 45 items rated from 0 (not at all) to 4 (a lot). It covers a total of 9 different symptomatic areas (e.g. depression, anxiety, interpersonal sensibility) and gives an overall severity score. Total score ranges from \[0 to 180\]. * Higher scores indicate a worse outcome (more severe symptoms). |
| Secondary | Change from Well-being at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Ryff's Scales of Psychological Well-Being (Ryff \& Keyes, 1995). * 29 items rated from 1 (strongly disagree) to 6 (strongly agree). The SPWB evaluates 6 dimensions of psychological well-being: Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Life purpose, and Personal growth. Scores ranges differ from scale to scale: * Self-acceptance \[4-24\] * Positive relationships \[5-30\] * Autonomy \[6-36\] * Environmental mastery \[5-30\] * Life purpose \[4-24\] * Personal growth \[5-30\] * Higher scores indicate a better outcome (more psychological wellbeing). |
| Secondary | Change from Satisfaction with life at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Satisfaction with Life Scale (SWLS; Diener et al., 1985). * 5 items rated from 1 (strongly disagree) to 7 (strongly agree). Total score ranges from 5 to 35. * Higher scores indicate a better outcome (more satisfaction with life). |
| Secondary | Change from Emotion Regulation at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Cognitive Emotion Regulation Questionnaire-short (CERQ-short; Garnefski \& Kraaij, 2007). * 18 items rated from 1 (almost never) to 5 (almost always). The CERQ-short evaluates 9 dimensions (composed by 2 items each): Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspectiva, Catastrophizing, and Other-blame. Each dimension ranges from 5 to 10. Also, two big dimensions are calculated depending on the type of strategy: * Sum of the adaptive subscales (acceptance, positive refocusing, refocus on planning, positive reappraisal, putting into perspective; 10 items) ranges from 10 to 50. Higher scores indicate a better outcome. * Sum of the maladaptive subscales (self-blame, rumination, catastrophizing, other-blame; 8 items) ranges from 8 to 40. Higher scores indicate a worse outcome. |
| Secondary | Change from Self-care at 12 weeks and 6 months | Baseline, end of treatment (week 12), and 6-month follow-up | Self-Care Scale (Spanish instrument; "Escala de autocuidado", Gonzalez et al., 2017), * 31 items rated from 1 (completely disagre) to 7 (completely agree). The scale evaluates dimensions: Self-destructive behaviors, Non-tolerance towards positive affect, Issues accepting help, Resentment due to non-reciprocity, No positive activities, and None attendace towards personal needs. * Higher scores indicate worse self-care. |
| Secondary | Change from depression at 12 weeks and 6 months | Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up | Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). * 9 items rated from 0 (not at all) to 3 (nearly every day). Total score ranges from 0 to 27. * Higher scores indicate a worse outcome (more severe 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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