ClinicalTrials.Veeva

Menu

Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care (Skills-PAVIP)

U

University Hospital, Clermont-Ferrand

Status

Not yet enrolling

Conditions

Social Skills
Primary Care

Treatments

Other: Questionary with a case-report-form

Study type

Observational

Funder types

Other

Identifiers

NCT07145528
CHU Clermont-Ferrand
2024-A00933-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

600 participants in 5 patient groups

Patients in Primary Care
Description:
A single E-case report form (CRF) for every group (a 45 minutes interview)
Treatment:
Other: Questionary with a case-report-form
Patients with chronic pain
Description:
A single E-case report form (CRF) for every group (a 45 minutes interview)
Treatment:
Other: Questionary with a case-report-form
Patients victims of violence
Description:
A single E-case report form (CRF) for every group (a 45 minutes interview)
Treatment:
Other: Questionary with a case-report-form
Patients perpetrators of violence
Description:
A single E-case report form (CRF) for every group (a 45 minutes interview)
Treatment:
Other: Questionary with a case-report-form
Patients with alcohol dependence
Description:
A single E-case report form (CRF) for every group (a 45 minutes interview)
Treatment:
Other: Questionary with a case-report-form

Trial contacts and locations

1

Loading...

Central trial contact

Lise Laclautre; Catherine Laporte, Pr

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems