Compassion-focused therapy for reducing self-stigma in mental health disorders

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

This study is testing whether Compassion Focused Therapy can help people with mental health disorders feel better about themselves and reduce feelings of shame.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Strasbourg, France (Academic / other)
• Locations: 7 sites (Bordeaux and 6 other locations)
• Trial ID: NCT05698589 on ClinicalTrials.gov

What this trial studies

This study aims to address self-stigma among individuals with chronic psychiatric disorders such as bipolar disorder, schizophrenia, depression, borderline personality disorder, and autism spectrum disorder. It employs Compassion Focused Therapy (CFT), a cognitive behavioral approach designed to reduce shame and improve self-compassion, which are critical for enhancing coping skills and treatment adherence. Participants will be assessed for their level of self-stigma and severity of their condition to determine eligibility. The intervention seeks to foster a more positive self-relationship and facilitate better integration into society.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic psychiatric or neurodevelopmental disorders experiencing moderate to high levels of self-stigma.

Not a fit: Patients currently in an acute episode of their disorder or those participating in other interventional studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the mental health and social integration of patients by reducing self-stigma and enhancing treatment adherence.

How similar studies have performed: While the specific application of Compassion Focused Therapy for self-stigma in these disorders is novel, similar therapeutic approaches have shown promise in improving mental health outcomes.

Eligibility criteria

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

Where this trial is running

Bordeaux and 6 other locations

• Pôle de Psychiatrie Adulte, Hôpital Charles Perrens — Bordeaux, France (Not_yet_recruiting)
• Ch Le Vinatier — Bron, France (Not_yet_recruiting)
• CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B — Clermont-Ferrand, France (Not_yet_recruiting)
• Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy — Laxou, France (Not_yet_recruiting)
• CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière — Montpellier, France (Not_yet_recruiting)
• Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale — Reims, France (Not_yet_recruiting)
• Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)

Study contacts

• Study coordinator: Luisa Weiner

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