跳至主要内容
临床试验/NCT07316803
NCT07316803招募中不适用

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

Centre hospitalier de Ville-Evrard, France2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Change in Romantic Relationship Functioning

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change in Romantic Relationship Functioning

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Centre hospitalier de Ville-Evrard, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raluca ROSETTI

Principal Investigator

Centre hospitalier de Ville-Evrard, France

研究点 (2)

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