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Clinical Trials/NCT07316803
NCT07316803
Recruiting
Not Applicable

Study on the Effectiveness of a Group Intervention on Romantic Relationships in Young Adults With Severe Mental Illness

Centre hospitalier de Ville-Evrard, France2 sites in 1 country20 target enrollmentStarted: November 3, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Centre hospitalier de Ville-Evrard, France
Enrollment
20
Locations
2
Primary Endpoint
Change in Romantic Relationship Functioning

Overview

Brief Summary

This study evaluates a group-based intervention designed to improve romantic and social relationship skills in adults living with a severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder.

Many adults with SMI experience loneliness, social isolation, and difficulties forming romantic relationships, even though most express a strong desire for intimacy. These challenges may be related to social skill difficulties, stigma, low self-esteem, and limited opportunities to develop healthy relationships.

The "À deux, c'est mieux" (Better Together) program is a structured 12-session group intervention focused on developing communication skills, emotional regulation, social understanding, and healthy romantic relationship behaviors. Sessions are led by trained mental health professionals and take place in small groups.

Participants will complete assessments before starting the program, at the end of the 12 sessions, and three months later. The study will examine changes in romantic relationship skills, quality of life, loneliness, self-esteem, self-stigma, and recovery.

The purpose of this study is to determine whether this intervention improves romantic and social functioning and overall well-being, and whether it is acceptable and relevant for adults living with severe mental illness.

Detailed Description

This multicenter, prospective study examines the effects of the "À deux, c'est mieux" group intervention on romantic and social functioning in adults living with a severe mental illness (SMI).

Romantic relationships are an important component of emotional well-being and social integration. However, adults with SMI often face significant barriers to forming and maintaining intimate relationships, including social skill challenges, limited social networks, stigma, low self-esteem, and fear of rejection. Although most express a desire for romantic relationships, many feel unprepared to develop or sustain healthy partnerships.

The "À deux, c'est mieux" program is a manualized group intervention consisting of 12 weekly sessions. The program follows a progressive structure, beginning with topics such as attraction, communication, and relationship initiation, and gradually addressing more sensitive themes including emotional intimacy, attachment-related anxiety, and sexuality. The intervention uses group discussions, experiential exercises, and practical strategies to promote healthy romantic relationship skills, emotional awareness, and social cognition. The program is inclusive of sexual and gender diversity.

The intervention will be delivered in small groups of 4 to 6 participants by trained mental health professionals. Outcomes will be assessed at three time points: before the intervention (baseline), immediately after completion of the 12 sessions, and at a three-month follow-up. The study uses a repeated single-case experimental design in which each participant serves as their own control, allowing for comparison of outcomes over time without the use of an inactive control group.

The primary outcome is improvement in romantic relationship functioning. Secondary outcomes include quality of life, perceived loneliness, self-esteem, internalized stigma, and recovery. Data will be analyzed using repeated-measures statistical methods to evaluate changes across assessment time points.

This study addresses an important gap in mental health care by focusing on romantic relationships and intimacy, areas that are often overlooked but central to recovery and quality of life.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

This is an open-label study. Participants and study staff are aware of the intervention being delivered. Masking is not feasible due to the behavioral and group-based nature of the intervention.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18 years and older
  • Diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder)
  • Currently single
  • Motivated to improve romantic and social relationships and to pursue a romantic relationship
  • Received mental health care within the past two years
  • Able and willing to provide informed consent

Exclusion Criteria

  • Inability to speak or read French
  • Currently receiving acute or crisis-level psychiatric care
  • Unable to comply with study procedures or group rules (e.g., maintaining sobriety during sessions)

Outcomes

Primary Outcomes

Change in Romantic Relationship Functioning

Time Frame: Baseline (pre-intervention), end of the 12-session intervention, and 3-month follow-up

Romantic relationship functioning will be assessed using the Romantic Relationships Functioning Scale, a self-report questionnaire measuring skills related to initiating, maintaining, and experiencing healthy romantic relationships. Higher scores indicate better romantic relationship functioning.

Secondary Outcomes

  • Change in Quality of Life(Baseline, end of the 12-session intervention, and 3-month follow-up)
  • Change in Recovery(Baseline, end of the 12-session intervention, and 3-month follow-up)
  • Change in Perceived Loneliness(Baseline, end of the 12-session intervention, and 3-month follow-up)
  • Change in Internalized Stigma(Baseline, end of the 12-session intervention, and 3-month follow-up)
  • Change in Self-Esteem(Baseline, end of the 12-session intervention, and 3-month follow-up)

Investigators

Sponsor
Centre hospitalier de Ville-Evrard, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Raluca ROSETTI

Principal Investigator

Centre hospitalier de Ville-Evrard, France

Study Sites (2)

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