NCT07316803

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

severe mental illnessomantic relationshipsintimate relationshipssocial functioning; lonelinessself-esteemself-stigmarecoverygroup interventionpsychosocial interventionsocial skills trainingrelationship skillsmental health rehabilitationadults with mental illness

Outcome Measures

Primary Outcomes (1)

  • Change in Romantic Relationship Functioning

    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.

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

Secondary Outcomes (5)

  • Change in Quality of Life

    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 Self-Esteem

    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 Recovery

    Baseline, end of the 12-session intervention, and 3-month follow-up

Study Arms (1)

À deux, c'est mieux Group Intervention

EXPERIMENTAL

Participants receive the "À deux, c'est mieux" group-based psychosocial intervention, a structured program designed to improve romantic and social relationship functioning in adults living with a severe mental illness. The intervention is delivered in small groups over 12 weekly sessions led by trained mental health professionals.

Behavioral: À deux, c'est mieux (Better Together) Group Intervention

Interventions

The "À deux, c'est mieux" intervention is a manualized, group-based psychosocial program consisting of 12 weekly sessions. The program targets the development of romantic relationship skills, including communication, emotional regulation, social cognition, and intimacy-related behaviors. Sessions follow a progressive structure, beginning with relationship initiation and communication skills and gradually addressing more sensitive topics such as emotional intimacy, attachment-related anxiety, and sexuality. The intervention is inclusive of sexual and gender diversity and is delivered by trained mental health professionals in groups of 4 to 6 participants.

Also known as: Better Together
À deux, c'est mieux Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HDJ (Hôpital de Jour)

Épinay-sur-Seine, Île-de-France Region, 93800, France

RECRUITING

L'UNIRRE (Unité Référente de Réhabilitation)

Neuilly-sur-Marne, Île-de-France Region, 93330, France

RECRUITING

Related Publications (9)

  • White R, Haddock G, Campodonico C, Haarmans M, Varese F. The influence of romantic relationships on mental wellbeing for people who experience psychosis: A systematic review. Clin Psychol Rev. 2021 Jun;86:102022. doi: 10.1016/j.cpr.2021.102022. Epub 2021 Mar 20.

    PMID: 33819779BACKGROUND
  • Weissbourd et al. The Talk: How Adults Can Promote Young People's Healthy Relationships and Prevent Misogyny and Sexual Harassment. (Harvard School of Education, 2017)

    BACKGROUND
  • Pillay R, Lecomte T, Abdel-Baki A. Factors limiting romantic relationship formation for individuals with early psychosis. Early Interv Psychiatry. 2018 Aug;12(4):645-651. doi: 10.1111/eip.12353. Epub 2016 May 17.

    PMID: 27186857BACKGROUND
  • Macdonald EM, Hayes RL, Baglioni AJ Jr. The quantity and quality of the social networks of young people with early psychosis compared with closely matched controls. Schizophr Res. 2000 Nov 30;46(1):25-30. doi: 10.1016/s0920-9964(00)00024-4.

    PMID: 11099882BACKGROUND
  • Hache-Labelle C, Abdel-Baki A, Lepage M, Laurin AS, Guillou A, Francoeur A, Bergeron S, Lecomte T. Romantic relationship group intervention for men with early psychosis: A feasibility, acceptability and potential impact pilot study. Early Interv Psychiatry. 2021 Aug;15(4):753-761. doi: 10.1111/eip.13012. Epub 2020 Jun 23.

    PMID: 32578401BACKGROUND
  • Bonfils KA, Firmin RL, Salyers MP, Wright ER. Sexuality and intimacy among people living with serious mental illnesses: Factors contributing to sexual activity. Psychiatr Rehabil J. 2015 Sep;38(3):249-55. doi: 10.1037/prj0000117. Epub 2015 Feb 9.

    PMID: 25664756BACKGROUND
  • Cloutier B, Lecomte T, Diotte F, Lamontagne J, Abdel-Baki A, Daneault JG, Gelineau Rabbath ME, de Connor A, Perrine C. Improving Romantic Relationship Functioning Among Young Men With First-Episode Psychosis: Impact of a Novel Group Intervention. Behav Modif. 2023 Sep;47(5):1170-1192. doi: 10.1177/01454455231186586. Epub 2023 Jul 26.

    PMID: 37496322BACKGROUND
  • Borge L, Martinsen EW, Ruud T, Watne O, Friis S. Quality of life, loneliness, and social contact among long-term psychiatric patients. Psychiatr Serv. 1999 Jan;50(1):81-4. doi: 10.1176/ps.50.1.81.

    PMID: 9890584BACKGROUND
  • Beyers W, Seiffge-Krenke I. Does Identity Precede Intimacy? Testing Erikson's Theory on Romantic Development in Emerging Adults of the 21st Century. Journal of Adolescent Research. 2010;25(3):387-415.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersSchizophreniaBipolar DisorderDepressive Disorder, MajorSocial Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersDepressive DisorderSocial BehaviorBehavior

Study Officials

  • Raluca ROSETTI, Principal Investigator

    Psychiatrist, EPS Ville-Evrard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef BENCHERIF, Clinical Project Manager

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study uses a repeated single-case experimental design in which all participants receive the same group-based intervention. Participants serve as their own control, with outcomes measured before the intervention, immediately after completion of the 12-session program, and at a three-month follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

November 3, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations