Pain, ChronicNCT06698406
Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale
An observational study of Pain, Chronic, run by Benno Rehberg-Klug at 1 site in Switzerland.
Trial summary
We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 26 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated by the ambulatory chronic pain clinic (consultation d'antalgie) of the HUG
Who may be able to join
- - Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG
- French-speaking and able to understand the study information
- ≥18 years of age
Who cannot join
- - Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other de-pendent persons
Trial locations and contacts
1 site in 1 country.
About this study
We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire
Read the detailed description
The primary objective is to validate the French version of the PEB scale, called "Echelle d'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".
The hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.
Consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.
- Conditions
- Pain, Chronic
- Keywords
- pain, chronic, patient education, self efficacy, bio-psycho-social model
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental validity of the new ABDC scale
Incremental validity is the degree to which a new scale increases the ability to predict an outcome beyond existing parameters and scales. In our case pain self-efficacy, measured by the "pain self-efficacy questionnaire" [8], which exists in a validated French version [9], is the outcome to be predicted.
Hierarchical regression analysis will have four models including in hierarchical order 8 explanatory variables: demographical variables (gender, age, level of education), depressive symptoms and anxiety, pain catastrophizing, pain acceptance, and finally the ABDC scale
Measured: 1 day
Secondary outcomes (3)
Reliability of the ABDC scale
Reliability will be evaluated as internal consistency, measured by Cronbach's alpha and corrected item-total-correlations.
Measured: 1 day
Convergent validity
Convergent validity will be evaluated by the correlation between the ABDC scale sum score and the "Survey of Pain Attitudes SOPA" scale [10], a self-administered questionnaire with 57 statements evaluating 7 categories of beliefs and attitudes about pain.
Measured: 1 day
Discriminant validity
correlations with the following scales which measure constructs which are important determinants of chronic pain severity, but independent of the endorsement of the biopsychosocial model by a patient: Brief Pain Inventory (BPI) The Brief Pain Inventory (BPI) [11] is a tool used to assess pain in patients. It was developed to measure both the intensity of pain and its impact on the patient's daily life. We will evaluate correlations with both the BPI-pain severity and the BPI-pain interference subscores.
Generalized anxiety disorder questionnaire GAD-7 The GAD-7 [12] is a questionnaire used to assess generalized anxiety disorder. It consists of seven questions that evaluate different symptoms associated with anxiety, such as nervousness, restlessness, and difficulty controlling worry.
Depressive symptoms: patient heath questionnaire PHQ-9 The PHQ-9 [13] is a screening tool for depression. It includes nine quest
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Nov 2024
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698406
- Sponsor's protocol ID
- ABDC validation
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale
- ClinicalTrials.gov ID
- NCT06698406
- Acronym / sponsor ID
- ABDC validation
- Conditions
- Pain, Chronic
- Keywords
- pain, chronic, patient education, self efficacy, bio-psycho-social model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire
Detailed description
The primary objective is to validate the French version of the PEB scale, called "Echelle d'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".
The hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.
Consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated by the ambulatory chronic pain clinic (consultation d'antalgie) of the HUG
Key inclusion criteria (3 listed)
- - Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG
- French-speaking and able to understand the study information
- ≥18 years of age
Key exclusion criteria (2 listed)
- - Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other de-pendent persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incremental validity of the new ABDC scale
Time frame: 1 day
Incremental validity is the degree to which a new scale increases the ability to predict an outcome beyond existing parameters and scales. In our case pain self-efficacy, measured by the "pain self-efficacy questionnaire" [8], which exists in a validated French version [9], is the outcome to be predicted. Hierarchical regression analysis will have four models including in hierarchical order 8 explanatory variables: demographical variables (gender, age, level of education), depressive symptoms and anxiety, pain catastrophizing, pain acceptance, and finally the ABDC scale
3 secondary outcomes
Reliability of the ABDC scale
Time frame: 1 day
Convergent validity
Time frame: 1 day
Discriminant validity
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by Benno Rehberg-Klug at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental validity of the new ABDC scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.