Social SkillsSkills-PAVIPNCT07145528
Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care
An observational study of Social Skills and Primary Care, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Skills, Primary Care
- What is being tested?
- Questionary with a case-report-form
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible patients attending participating primary care centers during the study period All eligible patients consulting in the pain center of Clermont-Ferrand and Lyon, at the addiction center of Grenoble and Clermont-Ferrand, at the center for the care of perpetrators and victims of violence in Clermont-Ferrand during the study period
Who may be able to join
- Patients aged 18 and over Suicidal: Patients at risk of suicide, or Suicidal : Patients who have attempted suicide, or Primary care patients
Who cannot join
- Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Pregnant and breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Lise LACLAUTRE, +334.73.751.195, drci@chu-clermontferrand.fr
Catherine LAPORTE
About this study
Official title: Social Skills in Adult Patients Followed for Chronic Pain, Addiction, Intimate Partner Violence or Followed in Primary Care: A Comparative Observational Study
Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.
Objectives: Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population.
Read more
Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic, intrinsic or environmental criteria
Type of study: multicenter comparative cross-sectional study
Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)
Study description: Cross-sectional, multicenter study. The patients will be included consecutively over a one-year period at the time of their visit to the inclusion center.
Primary endpoint: score obtained for each of the 4 axes on the ad hoc psychosocial skills assessment test.
Number of subjects: 600 patients (60 in each group)
Inclusion criteria
- Patients aged 18 and over,
- Patients with chronic pain lasting at least 6 months,
- Patients with alcohol dependence,
- Patients victims of intra-family violence,
- Patients who commit intra-family violence,
- Patients followed in primary care and not presenting any of the 4 previous items,
Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.
Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.
Read the detailed description
Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills.
Social skills provide the conditions for modulating and controlling emotions, improving individual and social skills, making appropriate decisions, and resisting social conflicts. Poor social skills are linked to psychological disorders and psychiatric disorders such as mood disorders. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.
I
Objectives:
Main objective Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population,
Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic (gender, age, geographical area), intrinsic (executive functions) or environmental criteria (childhood trauma, precariousness...).
Type of study: multicenter comparative cross-sectional study
Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)
Study description: This is a cross-sectional, multicenter study in the RIPH 2 category. The patients will be included consecutively over a one-year period at the time of their visit to the emergency department. This is an interventional study in that a questionnaire will be administered, asking questions about sensitive data. There will be no follow-up.
Primary endpoint: score obtained for each of the four axes on the ad hoc psychosocial skills assessment test.
Number of subjects: 600 patients (60 in each group)
Inclusion criteria
- Patients aged 18 and over,
- Patients with chronic pain lasting at least 6 months,
- Patients with alcohol dependence,
- Patients victims of intra-family violence,
- Patients who commit intra-family violence,
- Patients followed in primary care and not presenting any of the 4 previous items,
Non inclusion criteria Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Subjects participating in another interventional research study with an exclusion period still in progress at the time of inclusion.
Patients deprived of liberty, under guardianship, curators or safeguard of justice.
Pregnant and breast-feeding women
Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.
Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.
- Conditions
- Social Skills, Primary Care
- Being tested
- Questionary with a case-report-form
- Keywords
- intimate partner violence, addiction, chronic pain
- Medical subject headings
- Social Skills, Behavior, Addictive, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionary with a case-report-formOther
Questionary with : Gender, Age, Marital Status, medical history, Socio-économic description, skills assessment test written by R-Shankland, AUDIT-C, fargestrom, HAD, CAST, EPICE, Stroop-Test, Trail making test, Rosenberg Test
| Study group | Role | What they receive |
|---|---|---|
| Patients in Primary Care | A single E-case report form (CRF) for every group (a 45 minutes interview) Receives: Other: Questionary with a case-report-form | |
| Patients with chronic pain | A single E-case report form (CRF) for every group (a 45 minutes interview) Receives: Other: Questionary with a case-report-form | |
| Patients victims of violence | A single E-case report form (CRF) for every group (a 45 minutes interview) Receives: Other: Questionary with a case-report-form | |
| Patients perpetrators of violence | A single E-case report form (CRF) for every group (a 45 minutes interview) Receives: Other: Questionary with a case-report-form | |
| Patients with alcohol dependence | A single E-case report form (CRF) for every group (a 45 minutes interview) Receives: Other: Questionary with a case-report-form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of psychosocial skills
15-item scale, grouped into 4 axes: emotional (5 items), cognitive (4 items), social (4 items), assertiveness (2 items). The response modality is a Likert scale with 7 possible answers ranging from "Never" (1) to "Always" (7). The alpha-cronbach coefficient was 0.754 for the cognitive axis, 0.731 for the social axis and 0.654 for the emotional axis
Measured: 5 minutes
Secondary outcomes (1)
Results of the others test
Sociodemographics criterias, intrinsics criteria, medical history, patient's health
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social SkillsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Laporte, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145528
- Sponsor's protocol ID
- CHU Clermont-Ferrand
- Other IDs
- 2024-A00933-44
- Acronym
- Skills-PAVIP
- Status last verified
- Jul 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Skills in Adult Patients Followed for Chronic Pain, Addiction, Intimate Partner Violence or Followed in Primary Care: A Comparative Observational Study
- ClinicalTrials.gov ID
- NCT07145528
- Acronym / sponsor ID
- Skills-PAVIP / CHU Clermont-Ferrand
- Conditions
- Social Skills, Primary Care
- Keywords
- intimate partner violence, addiction, chronic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.
Objectives: Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population.
Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic, intrinsic or environmental criteria
Type of study: multicenter comparative cross-sectional study
Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)
Study description: Cross-sectional, multicenter study. The patients will be included consecutively over a one-year period at the time of their visit to the inclusion center.
Primary endpoint: score obtained for each of the 4 axes on the ad hoc psychosocial skills assessment test.
Number of subjects: 600 patients (60 in each group)
Inclusion criteria
- Patients aged 18 and over,
- Patients with chronic pain lasting at least 6 months,
- Patients with alcohol dependence,
- Patients victims of intra-family violence,
- Patients who commit intra-family violence,
- Patients followed in primary care and not presenting any of the 4 previous items,
Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.
Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.
Detailed description
Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills.
Social skills provide the conditions for modulating and controlling emotions, improving individual and social skills, making appropriate decisions, and resisting social conflicts. Poor social skills are linked to psychological disorders and psychiatric disorders such as mood disorders. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.
I
Objectives:
Main objective Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population,
Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic (gender, age, geographical area), intrinsic (executive functions) or environmental criteria (childhood trauma, precariousness...).
Type of study: multicenter comparative cross-sectional study
Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)
Study description: This is a cross-sectional, multicenter study in the RIPH 2 category. The patients will be included consecutively over a one-year period at the time of their visit to the emergency department. This is an interventional study in that a questionnaire will be administered, asking questions about sensitive data. There will be no follow-up.
Primary endpoint: score obtained for each of the four axes on the ad hoc psychosocial skills assessment test.
Number of subjects: 600 patients (60 in each group)
Inclusion criteria
- Patients aged 18 and over,
- Patients with chronic pain lasting at least 6 months,
- Patients with alcohol dependence,
- Patients victims of intra-family violence,
- Patients who commit intra-family violence,
- Patients followed in primary care and not presenting any of the 4 previous items,
Non inclusion criteria Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Subjects participating in another interventional research study with an exclusion period still in progress at the time of inclusion.
Patients deprived of liberty, under guardianship, curators or safeguard of justice.
Pregnant and breast-feeding women
Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.
Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients in Primary Care | – | Other: Questionary with a case-report-formA single E-case report form (CRF) for every group (a 45 minutes interview) |
| Patients with chronic pain | – | Other: Questionary with a case-report-formA single E-case report form (CRF) for every group (a 45 minutes interview) |
| Patients victims of violence | – | Other: Questionary with a case-report-formA single E-case report form (CRF) for every group (a 45 minutes interview) |
| Patients perpetrators of violence | – | Other: Questionary with a case-report-formA single E-case report form (CRF) for every group (a 45 minutes interview) |
| Patients with alcohol dependence | – | Other: Questionary with a case-report-formA single E-case report form (CRF) for every group (a 45 minutes interview) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients attending participating primary care centers during the study period All eligible patients consulting in the pain center of Clermont-Ferrand and Lyon, at the addiction center of Grenoble and Clermont-Ferrand, at the center for the care of perpetrators and victims of violence in Clermont-Ferrand during the study period
Key inclusion criteria (1 listed)
- Patients aged 18 and over Suicidal: Patients at risk of suicide, or Suicidal : Patients who have attempted suicide, or Primary care patients
Key exclusion criteria (1 listed)
- Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Pregnant and breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionary with a case-report-formQuestionary with : Gender, Age, Marital Status, medical history, Socio-économic description, skills assessment test written by R-Shankland, AUDIT-C, fargestrom, HAD, CAST, EPICE, Stroop-Test, Trail making test, Rosenberg Test | Other | Patients in Primary Care, Patients perpetrators of violence, Patients victims of violence, Patients with alcohol dependence, Patients with chronic pain |
Primary outcome
Score of psychosocial skills
Time frame: 5 minutes
15-item scale, grouped into 4 axes: emotional (5 items), cognitive (4 items), social (4 items), assertiveness (2 items). The response modality is a Likert scale with 7 possible answers ranging from "Never" (1) to "Always" (7). The alpha-cronbach coefficient was 0.754 for the cognitive axis, 0.731 for the social axis and 0.654 for the emotional axis
1 secondary outcome
Results of the others test
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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OBEDIAM: Therapeutic Patient Education in Adults Living With Obesity, Diabetes, and Metabolic Disorders
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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.
Catherine Laporte, Pr principal investigator
University Hospital, Clermont-Ferrand
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 Social Skills and Primary Care, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+334.73.751.195, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of psychosocial skills (time frame: 5 minutes). 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 28 Aug 2025.