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COMpassion for Psychiatric Disorders And Self-Stigma (COMPASS)

Primary Purpose

Bipolar Disorder, Schizophrenia, Depression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Compassion Focused Therapy
Ending Self Stigma
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion criteria: 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Compassion Focused Therapy

Ending Self Stigma

Treatment As Usual

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT05698589
Brief Title
COMpassion for Psychiatric Disorders And Self-Stigma
Acronym
COMPASS
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
March 1, 2028 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizophrenia, Depression, Borderline Personality Disorder, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compassion Focused Therapy
Arm Type
Experimental
Arm Title
Ending Self Stigma
Arm Type
Active Comparator
Arm Title
Treatment As Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Compassion Focused Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ending Self Stigma
Intervention Description
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
Primary Outcome Measure Information:
Title
Internalized Stigma of Mental Illness inventory (ISMI)
Description
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
Time Frame
Day 0
Title
Internalized Stigma of Mental Illness inventory (ISMI)
Description
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
Time Frame
Month 1
Title
Internalized Stigma of Mental Illness inventory (ISMI)
Description
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
Time Frame
Month 2
Title
Internalized Stigma of Mental Illness inventory (ISMI)
Description
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
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luisa Weiner
Phone
0033388116312
Email
weiner@unistra.fr
Facility Information:
Facility Name
Pôle de Psychiatrie Adulte, Hôpital Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David MISDRAHI, MD
Phone
33.5.56.56.34.49
Email
david.misdrahi@u-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
David MISDRAHI, MD
Facility Name
Ch Le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas FRANCK, MD
Phone
33.6.98.52.68.89
Email
Nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Nicolas FRANCK, MD
Facility Name
CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Michel LLORCA, MD
Phone
33.4.73.75.20.78
Email
pllorca@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Michel LLORCA, MD
Facility Name
Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy
City
Laxou
ZIP/Postal Code
54520
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David MASSON, MD
Phone
33.6.09.63.20.45
Email
david.masson@cpn-laxou.com
First Name & Middle Initial & Last Name & Degree
David MASSON, MD
Facility Name
CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE, MD
Phone
33.6.87.12.44.56
Email
d-capdevielle@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE, MD
Facility Name
Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina TRAYKOVA- BOGOVA, MD
Phone
33.3.26.86.86.14
Email
traykovam@epsm-mame.fr
First Name & Middle Initial & Last Name & Degree
Martina TRAYKOVA- BOGOVA, MD
Facility Name
Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa WEINER, MD
Phone
33.3.88.11.65.11
Email
weiner@unistra.fr
First Name & Middle Initial & Last Name & Degree
Sébastien WEIBEL, MD
Phone
33.3.88.11.51.57
Email
sebastien.weibel@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Sébastien WEIBEL, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COMpassion for Psychiatric Disorders And Self-Stigma

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