COMpassion for Psychiatric Disorders And Self-Stigma (COMPASS)

Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study

People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma.

In this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.

Study Overview

• Status: Recruiting
• Conditions: Depression; Schizophrenia; Bipolar Disorder; Autism Spectrum Disorder; Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Compassion Focused Therapy; Behavioral: Ending Self Stigma

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luisa Weiner; Phone Number: 0033388116312; Email: weiner@unistra.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Pôle de Psychiatrie Adulte, Hôpital Charles Perrens
    • Contact: David MISDRAHI, MD; Phone Number: 33.5.56.56.34.49; Email: david.misdrahi@u-bordeaux.fr
    • Principal Investigator: David MISDRAHI, MD
  • Bron, France, 69678
    • Not yet recruiting
    • CH Le Vinatier
    • Contact: Nicolas FRANCK, MD; Phone Number: 33.6.98.52.68.89; Email: Nicolas.franck@ch-le-vinatier.fr
    • Principal Investigator: Nicolas FRANCK, MD
  • Clermont-Ferrand, France, 63003
    • Not yet recruiting
    • CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B
    • Contact: Pierre-Michel LLORCA, MD; Phone Number: 33.4.73.75.20.78; Email: pllorca@chu-clermontferrand.fr
    • Principal Investigator: Pierre-Michel LLORCA, MD
  • Laxou, France, 54520
    • Not yet recruiting
    • Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy
    • Contact: David MASSON, MD; Phone Number: 33.6.09.63.20.45; Email: david.masson@cpn-laxou.com
    • Principal Investigator: David MASSON, MD
  • Montpellier, France, 34295
    • Not yet recruiting
    • CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière
    • Contact: Delphine CAPDEVIELLE, MD; Phone Number: 33.6.87.12.44.56; Email: d-capdevielle@chu-montpellier.fr
    • Principal Investigator: Delphine CAPDEVIELLE, MD
  • Reims, France, 51100
    • Not yet recruiting
    • Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale
    • Contact: Martina TRAYKOVA- BOGOVA, MD; Phone Number: 33.3.26.86.86.14; Email: traykovam@epsm-mame.fr
    • Principal Investigator: Martina TRAYKOVA- BOGOVA, MD
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
    • Contact: Luisa WEINER, MD; Phone Number: 33.3.88.11.65.11; Email: weiner@unistra.fr
    • Contact: Sébastien WEIBEL, MD; Phone Number: 33.3.88.11.51.57; Email: sebastien.weibel@chru-strasbourg.fr
    • Principal Investigator: Sébastien WEIBEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient ≥18 years of age
2. Patient informed of the results of the preliminary medical examination
3. Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)
4. Patient with one or several diagnoses of chronic psychiatric disorder (schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depression, borderline personality disorder) or a neurodevelopmental disorder (autism spectrum disorder) treated as an outpatient or in a day hospital

5. CGI-Severity score<6 assessed by the psychiatrist (Berk et al., 2008) ISMI score indicating moderate to high self-stigma (>2.5; Lysaker et al., 2007)

   Exclusion criteria:

6. Patient in an exclusion period determined by a previous or ongoing study
7. Patient participating in an interventional study involving psychotherapy or an experimental drug
8. Patient in acute episode of their disorder according to the CGI Severity score
9. Patient in a medical emergency or immediate life-threatening situation
10. Patients with an intellectual disability (IQ<70) estimated via the fNART (Mackinnon & Mulligan, 2005)

12. Legal issues: care under constraint or patient deprived of freedom because of a judicial measure 13. Patient who does not speak and read French sufficiently

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual
Experimental: Compassion Focused Therapy	Behavioral: Compassion Focused Therapy; CFT is an experiential therapy. As such, in addition to psychoeducation components (e.g.: compassion from an evolutionary and neuroscientific perspective, the tricky brain problem, emotion regulation systems) and explicit learning of emotion regulation skills (in particular, shame), experiential exercises are provided in-sessions (e.g. : chair work, role plays, guided mental imagery, …) and between sessions practices will be provided with video guides, made available for the participants online (e.g. : soothing rhythm breathing, safe place imagery, compassionate self-imagery, …). The overall aim of the CFT program is to help participants shift from a hostile and critical self-to-self relationship to a more compassionate relationship to self.
Active Comparator: Ending Self Stigma	Behavioral: Ending Self Stigma; Psychoeducation sessions cover topics such as the path from public stigma to self-stigma and modifying self-stigmatizing thoughts. Participants will be encouraged to do home practices (e.g. writing about the pros and cons of self-stigmatizing thoughts) between sessions. The overall aim of the ESS program is to help participants address self-stigma with concrete tools to increase their self-esteem and achieve their goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalized Stigma of Mental Illness inventory (ISMI)	ISMI is : Internalized Stigma of Mental Illness Scale , The participant must select their response on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4), hence the minimum and maximum score values are respectively 1 and 4. Higher scores mean worse outcome	Day 0
Internalized Stigma of Mental Illness inventory (ISMI)	ISMI is : Internalized Stigma of Mental Illness Scale , The participant must select their response on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4), hence the minimum and maximum score values are respectively 1 and 4. Higher scores mean worse outcome	Month 1
Internalized Stigma of Mental Illness inventory (ISMI)	ISMI is : Internalized Stigma of Mental Illness Scale , The participant must select their response on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4), hence the minimum and maximum score values are respectively 1 and 4. Higher scores mean worse outcome	Month 2
Internalized Stigma of Mental Illness inventory (ISMI)	ISMI is : Internalized Stigma of Mental Illness Scale , The participant must select their response on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4), hence the minimum and maximum score values are respectively 1 and 4. Higher scores mean worse outcome	Month 3

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Schizophrenia; Bipolar Disorder; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 8566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No