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Not yet recruiting NCT07145528

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

Observational Social Skills Primary Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionary with a case-report-form.
Who it may be relevant to
Registry conditions: Social Skills, Primary Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Score of psychosocial skills [Time frame: 5 minutes]
Secondary outcome measures (1)
  • Results of the others test [Time frame: 45 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07145528 · CHU Clermont-Ferrand · 2024-A00933-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗