COMpassion for Psychiatric Disorders And Self-Stigma

NCT05698589 | Recruiting

• 1 other identifier: 8566
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Bipolar Disorder; Schizophrenia; Depression; Borderline Personality Disorder; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Compassion Focused Therapy

EXPERIMENTAL

Behavioral: Compassion Focused Therapy

Ending Self Stigma

ACTIVE COMPARATOR

Behavioral: Ending Self Stigma

Treatment As Usual

NO INTERVENTION

Interventions

Compassion Focused Therapy 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.

Compassion Focused Therapy

Ending Self Stigma 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

Ending Self Stigma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18 years of age
• Patient informed of the results of the preliminary medical examination
• Patient affiliated to a social health insurance plan (beneficiary or beneficiary's family)
• 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
• 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)

You may not qualify if:

• Patient participating in an interventional study involving psychotherapy or an experimental drug
• Patient in acute episode of their disorder according to the CGI Severity score
• Patient in a medical emergency or immediate life-threatening situation
• Patients with an intellectual disability (IQ\<70) estimated via the fNART (Mackinnon \& Mulligan, 2005)
• \. 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (7)

Pôle de Psychiatrie Adulte, Hôpital Charles Perrens

Bordeaux, 33076, France

NOT YET RECRUITING

Ch Le Vinatier

Bron, 69678, France

NOT YET RECRUITING

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

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

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

Laxou, 54520, France

NOT YET RECRUITING

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

Montpellier, 34295, France

NOT YET RECRUITING

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

Reims, 51100, France

NOT YET RECRUITING

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37309006 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia; Depression; Borderline Personality Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior; Personality Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Central Study Contacts

Luisa Weiner

CONTACT

0033388116312; weiner@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 26, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)