Clinical trial NCT05698589: COMpassion for Psychiatric Disorders And Self-Stigma
Official title: Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Schizophrenia
Depression
Borderline Personality Disorder
Autism Spectrum Disorder
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Internalized Stigma of Mental Illness inventory (ISMI)
timeFrame: Day 0
measure: Internalized Stigma of Mental Illness inventory (ISMI)
timeFrame: Month 1
measure: Internalized Stigma of Mental Illness inventory (ISMI)
timeFrame: Month 2
measure: Internalized Stigma of Mental Illness inventory (ISMI)
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pôle de Psychiatrie Adulte, Hôpital Charles Perrens
city: Bron
country: France
facility: Ch Le Vinatier
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B
city: Laxou
country: France
facility: Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy
city: Montpellier
country: France
facility: CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière
city: Reims
country: France
facility: Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale
city: Strasbourg
country: France
facility: Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
References: