NCT07145528

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

February 19, 2025

Last Update Submit

August 20, 2025

Conditions

Keywords

intimate partner violenceaddictionchronic pain

Outcome Measures

Primary Outcomes (1)

  • 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

    5 minutes

Secondary Outcomes (1)

  • Results of the others test

    45 minutes

Study Arms (5)

Patients in Primary Care

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

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)

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)

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)

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)

Other: Questionary with a case-report-form

Interventions

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 in Primary CarePatients perpetrators of violencePatients victims of violencePatients with alcohol dependencePatients with chronic pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients aged 18 and over Suicidal: Patients at risk of suicide, or Suicidal : Patients who have attempted suicide, or Primary care patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Social SkillsBehavior, AddictiveChronic Pain

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorCompulsive BehaviorImpulsive BehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Laporte, Pr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

August 28, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations