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NCT Number: NCT07145528

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location contact

Catherine LAPORTE

PRINCIPAL_INVESTIGATOR

Lise LACLAUTRE

CONTACT

[email protected]

+334.73.751.195

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionary with a case-report-form

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Results of the others test

    Time frame: 45 minutes

    Sociodemographics criterias, intrinsics criteria, medical history, patient's health

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Laporte, Pr

CONTACT

[email protected]

+336.11.37.55.52

Lise Laclautre

CONTACT

[email protected]

+334.73.751.195

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Social Skills in Adult Patients Followed for Chronic Pain, Addiction, Intimate Partner Violence or Followed in Primary Care: A Comparative Observational Study

Acronym: Skills-PAVIP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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