COMpassion for Psychiatric Disorders And Self-Stigma

NCT ID: NCT05698589

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2028-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Schizophrenia Depression Borderline Personality Disorder Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Compassion Focused Therapy

Group Type EXPERIMENTAL

Compassion Focused Therapy

Intervention Type BEHAVIORAL

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.

Ending Self Stigma

Group Type ACTIVE_COMPARATOR

Ending Self Stigma

Intervention Type BEHAVIORAL

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

Treatment As Usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pôle de Psychiatrie Adulte, Hôpital Charles Perrens

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Ch Le Vinatier

Bron, , France

Site Status NOT_YET_RECRUITING

CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy

Laxou, , France

Site Status NOT_YET_RECRUITING

CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière

Montpellier, , France

Site Status NOT_YET_RECRUITING

Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale

Reims, , France

Site Status NOT_YET_RECRUITING

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Luisa Weiner

Role: CONTACT

0033388116312

Facility Contacts

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David MISDRAHI, MD

Role: primary

33.5.56.56.34.49

Nicolas FRANCK, MD

Role: primary

33.6.98.52.68.89

Pierre-Michel LLORCA, MD

Role: primary

33.4.73.75.20.78

David MASSON, MD

Role: primary

33.6.09.63.20.45

Delphine CAPDEVIELLE, MD

Role: primary

33.6.87.12.44.56

Martina TRAYKOVA- BOGOVA, MD

Role: primary

33.3.26.86.86.14

Luisa WEINER, MD

Role: primary

33.3.88.11.65.11

Sébastien WEIBEL, MD

Role: backup

33.3.88.11.51.57

References

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Riebel M, Rohmer O, Charles E, Lefebvre F, Weibel S, Weiner L. Compassion-focused therapy (CFT) for the reduction of the self-stigma of mental disorders: the COMpassion for Psychiatric disorders, Autism and Self-Stigma (COMPASS) study protocol for a randomized controlled study. Trials. 2023 Jun 12;24(1):393. doi: 10.1186/s13063-023-07393-y.

Reference Type DERIVED
PMID: 37309006 (View on PubMed)

Other Identifiers

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8566

Identifier Type: -

Identifier Source: org_study_id

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