Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care

NCT ID: NCT07145528

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief 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. 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.

Conditions

Social Skills; Primary Care

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients in Primary Care

A single E-case report form (CRF) for every group (a 45 minutes interview)

Questionary with a case-report-form

Intervention Type: OTHER

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 a case-report-form

Intervention Type: OTHER

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 a case-report-form

Intervention Type: OTHER

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 a case-report-form

Intervention Type: OTHER

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 a case-report-form

Intervention Type: OTHER

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

Interventions

Questionary with a case-report-form

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Laporte, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

drci@chu-clermontferrand.fr

+334.73.751.195

Catherine Laporte, Pr

Role: CONTACT

catherine.laporte2@uca.fr

+336.11.37.55.52

Facility Contacts

Lise LACLAUTRE

Role: primary

drci@chu-clermontferrand.fr

+334.73.751.195

Other Identifiers

2024-A00933-44

Identifier Type: OTHER

Identifier Source: secondary_id

CHU Clermont-Ferrand

Identifier Type: -

Identifier Source: org_study_id