Trial · NCT07791355
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retention rate | From enrollment to 9 weeks (post treatment). | The retention rate is defined as the percentage of participants who successfully complete the PRT intervention. To be considered a completer, a participant must attend at least 6 of the 9 individual sessions and complete all post-treatment outcome measures. The benchmark for study feasibility is set at 75% |
| Primary | Recruitment rate | From study start to recruitment completion, an estimated 6 months | Feasibility of recruitment, defined as percentage of eligible participants who give informed consent and are enrolled in the study. The predefined benchmark for feasibility of recruitment rate is set as at least 70% |
| Primary | Patient treatment satisfaction | Post treatment (9 weeks) | Assessed using the Client Satisfaction Questionnaire (CSQ-8). The total score ranges from 8 to 32. Higher scores indicate greater satisfaction with the treatment received, representing a better outcome. The predefined benchmark for acceptability is set to a mean total score of 24 or higher (out of a maximum of 32). |
| Primary | Adherence to treatment | From enrollment to the end of the treatment at 9 weeks | Adherence to the in-between session work with home assignments, as logged by the therapists during the 9-week program. The predefined benchmark for adequate adherence is at least 70% of assigned homework tasks. |
| Primary | Therapists treatment fidelity | From treatment start to the end of treatment at 9 weeks | The degree to which the therapists adhere to the core interventions of the treatment. Evaluated by therapist self-report using a study-specific PRT fidelity checklist completed after each session. The predefined benchmark for adequate treatment fidelity is set to an average adherence score of at least 80%. |
| Secondary | Pain Catastrophizing Scale (PCS) | Baseline and week 9 | The PCS assesses negative thoughts and emotions associated with past, present or anticipated pain. The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing. |
| Secondary | Tampa Scale of Kinesiophobia (TSK) | Baseline and week 9 | The TSK assesses fear of movement or re-injury. The 17-item version is used. Total scores range from 17 to 68. Higher scores indicates a higher degree of kinesiophobia. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Baseline and week 9 | The HADS scale measures anxiety and depression symptoms. The HADS contains of 14 items, divided into 2 subscales (anxiety and depression). For each subscale, the total score ranges from 0 to 21. Higher scores indicate greater severity of anxiety and depression symptoms. |
| Secondary | EQ-5D | Baseline and week 9 (post treatment) | The EQ-5D measures health-related quality of life across five dimensions. Responses are converted into a single index score. The index score typically ranges from a minimum of less than 0 (often around -0.59, representing a health state worse than death) to a maximum of 1.0 (representing full health). Higher index scores indicate a better health-related quality of life. |
| Secondary | EQ-5D VAS | Baseline to 9 week (post treatment) | Measures self-rated overall health using a Visual Analogue Scale (EQ-VAS). Participants rate their overall health using a vertical visual analogue scale rangeing from 0-100. Higher scores indicates a better self-percieved health. |
| Secondary | Sickness Questionnaire (SicknessQ) | Baseline and week 9. | The SicknessQ assesses self-reported sickness behavior (e.g., fatigue, social withdrawal. The scores ranges from 0 tp 30. Higher scores indicate a higher degree of sickness behavior. |
| Secondary | Multidimensional Fatigue Inventory (MFI-20) | Baseline to 9-week (post treatment) | The MFI-20 assesses five dimensions of fatigue. The total score ranges from 20-100 where higher scores indicate higher levels of fatigue. |
| Secondary | Numeric Rating Scale For Pain | Baseline and week 9 (Post treatment) | The NRS measures pain intensity where participants rate their pain intensity during the past week on an 11 point scale from 0 to 10. Higher scores indicate worse pain intensity. |
| Secondary | Consultation and Relational Empathy Measure (CARE) | Week 2 and 9 (post treatment) | The CARE-scale assesses the participants perception of the therapists empathy during sessions. The maximum score is 50. Higher scores indicate greater percieved empathy from the treating clinician |
| Secondary | Credibility/Expectancy Questionnaire (CEQ) | Week 2 | The CEQ assesses how logical the treatment seems to the patient, and how much improvement they expect. Scores for each subscale range from 3 to 27. Higher scores indicate higher perceived credibility and expectancy of clinical improvement. |
| Other | Pressure Pain Threshold (PPT) | Baseline and 9-week | Assessed using a pressure algometer. Measures are recorded in kPa at predefined anatomical sites. Higher values indicate higher pain thresholds. |
| Other | Thermal Pain Thresholds | Baseline and week 9 (Post treatment) | Assessed using a computerized thermotest device. Heat Pain Threshold (HPT) and Cold Pain Threshold (CPT) are measured in degrees Celcius. For HPT, higher temperatures indicate a higher pain threshold. For CPT, lower temperatures indicate a higher pain threshold. |
| Other | PrePain Questionnaire | Before treatment start and 9 weeks (post treatment) | The PrePain questionnaire assesses attitudes, emotions and behaviors related to pain. The six dimensional questions (assessing perceived pain-sensitivity, avoidance, distress, relief, focus on symptoms, and negative thoughts) are analyzed individually rather than as a total score. Each item is scored on a Visual Analog Scale (VAS) with a minimum value of 0 and a maximum value of 100. A VAS-score of 100 means respectively low pain-sensitivity, low degree of avoidance, low degree of distress, low degree of relief, low degree focus on symptoms and low degree of negative thoughts. Because higher scores represent a lower degree of these pain-related attitudes and emotions, higher scores indicate a better outcome. |
| Other | Stroop-test | Baseline and 9 weeks (post treatment) | Executive control, attention, and inhibition are assessed using a digital version of the Stroop test administered via the 'Health Catcher' application. Participants are instructed to respond to the color of a written word rather than the word itself. Performance is measured by the total number of correct responses completed within a 90-second time limit. The minimum possible score is 0. There is no predefined maximum score, as the total number of items presented depends on the participant's response speed. Higher scores (more correct responses within the time limit) indicate better cognitive performance and inhibition. |
| Other | Go/no-go Test | Baseline and 9 weeks (post treatment) | Sustained attention and response inhibition are assessed using a digital Go/no-go test administered via the 'Health Catcher' application. Participants respond to a target stimulus while withholding responses to a non-target stimulus. Performance is measured by the total number of correct responses completed within a 90-second time limit. The minimum possible score is 0. There is no predefined maximum score, as the total number of items presented depends on the participant's response speed. Higher scores (more correct responses within the time limit) indicate better sustained attention and response inhibition. |
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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