COMpassion for Psychiatric Disorders And Self-Stigma

Not Applicable

Recruiting

• Conditions: Schizophrenia; Depression; Bipolar Disorder; Borderline Personality Disorder; Autism Spectrum Disorder
• Interventions: Behavioral: Compassion Focused Therapy; Behavioral: Ending Self Stigma

• Registration Number: NCT05698589
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Study Start: 2023-04-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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)

11. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compassion Focused Therapy	Compassion Focused Therapy	-
Ending Self Stigma	Ending Self Stigma	-

Primary Outcome Measures

Name	Time	Method
Internalized Stigma of Mental Illness inventory (ISMI)	Month 3	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

Trial Locations

Locations (7)

Pôle de Psychiatrie Adulte, Hôpital Charles Perrens; 🇫🇷 Bordeaux, France

Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy; 🇫🇷 Laxou, France

Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale; 🇫🇷 Reims, France

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Ch Le Vinatier; 🇫🇷 Bron, France

CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière; 🇫🇷 Montpellier, France

CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B; 🇫🇷 Clermont-Ferrand, France