COMpassion for Psychiatric Disorders And Self-Stigma

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Internalized Stigma of Mental Illness inventory (ISMI) [Срок оценки: Day 0]
• Internalized Stigma of Mental Illness inventory (ISMI) [Срок оценки: Month 1]
• Internalized Stigma of Mental Illness inventory (ISMI) [Срок оценки: Month 2]
• Internalized Stigma of Mental Illness inventory (ISMI) [Срок оценки: Month 3]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Patient in an exclusion period determined by a previous or ongoing study
• 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)

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

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

Публикации

• 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

Идентификаторы

NCT: NCT05698589 · 8566

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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