- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07145528
- Original Trial
Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care (Skills-PAVIP)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lise LACLAUTRE
- Phone Number: +334.73.751.195
- Email: drci@chu-clermontferrand.fr
Study Contact Backup
- Name: Catherine Laporte, Pr
- Phone Number: +336.11.37.55.52
- Email: catherine.laporte2@uca.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- CHU clermont-ferrand
-
Contact:
- Lise LACLAUTRE
- Phone Number: +334.73.751.195
- Email: drci@chu-clermontferrand.fr
-
Principal Investigator:
- Catherine LAPORTE
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
Inclusion Criteria:
Patients aged 18 and over Suicidal: Patients at risk of suicide, or Suicidal : Patients who have attempted suicide, or Primary care patients
Exclusion 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, Pregnant and breast-feeding women
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients in Primary Care
A single E-case report form (CRF) for every group (a 45 minutes interview)
|
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
|
|
Patients with chronic pain
A single E-case report form (CRF) for every group (a 45 minutes interview)
|
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
|
|
Patients victims of violence
A single E-case report form (CRF) for every group (a 45 minutes interview)
|
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
|
|
Patients perpetrators of violence
A single E-case report form (CRF) for every group (a 45 minutes interview)
|
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
|
|
Patients with alcohol dependence
A single E-case report form (CRF) for every group (a 45 minutes interview)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Results of the others test
Time Frame: 45 minutes
|
Sociodemographics criterias, intrinsics criteria, medical history, patient's health
|
45 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine Laporte, Pr, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU Clermont-Ferrand
- 2024-A00933-44 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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