COMpassion for Psychiatric Disorders And Self-Stigma

Depression Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698589
• Other study ID #: 8566
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: March 1, 2028

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Luisa Weiner
• Phone: 0033388116312
• Email: weiner[@]unistra.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Bipolar Disorder
• Borderline Personality Disorder
• Depression
• Personality Disorders
• Schizophrenia

Intervention

Behavioral:
• 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 (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.
• 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

Locations

Country	Name	City	State
France	Pôle de Psychiatrie Adulte, Hôpital Charles Perrens	Bordeaux
France	Ch Le Vinatier	Bron
France	CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B	Clermont-Ferrand
France	Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy	Laxou
France	CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière	Montpellier
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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