Bipolar DisorderCOMPASSNCT05698589
COMpassion for Psychiatric Disorders And Self-Stigma
A study testing Compassion Focused Therapy and Ending Self Stigma in people with Bipolar Disorder and Schizophrenia, run by University Hospital, Strasbourg, France at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Depression
- What is being tested?
- Compassion Focused Therapy and Ending Self Stigma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Apr 2023to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Pôle de Psychiatrie Adulte, Hôpital Charles Perrens
Bordeaux, 33076
David MISDRAHI, MD, 33.5.56.56.34.49, david.misdrahi@u-bordeaux.fr
David MISDRAHI, MD
- Not yet recruiting
Ch Le Vinatier
Bron, 69678
Nicolas FRANCK, MD, 33.6.98.52.68.89, Nicolas.franck@ch-le-vinatier.fr
Nicolas FRANCK, MD
- Not yet recruiting
CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B
Clermont-Ferrand, 63003
Pierre-Michel LLORCA, MD, 33.4.73.75.20.78, pllorca@chu-clermontferrand.fr
Pierre-Michel LLORCA, MD
- Not yet recruiting
Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy
Laxou, 54520
David MASSON, MD, 33.6.09.63.20.45, david.masson@cpn-laxou.com
David MASSON, MD
- Not yet recruiting
CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière
Montpellier, 34295
Delphine CAPDEVIELLE, MD, 33.6.87.12.44.56, d-capdevielle@chu-montpellier.fr
Delphine CAPDEVIELLE, MD
- Not yet recruiting
Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale
Reims, 51100
Martina TRAYKOVA- BOGOVA, MD, 33.3.26.86.86.14, traykovam@epsm-mame.fr
Martina TRAYKOVA- BOGOVA, MD
- Recruiting
Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Luisa WEINER, MD, 33.3.88.11.65.11, weiner@unistra.fr
Sébastien WEIBEL, MD, 33.3.88.11.51.57, sebastien.weibel@chru-strasbourg.fr
About this study
Official title: Compassion Focused Therapy (CFT) for the Reduction of the Internalized Stigma of Mental Disorders: a Multi-center, Prospective, Randomized, Controlled Study
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.
- Conditions
- Bipolar Disorder, Schizophrenia, Depression, Borderline Personality Disorder, Autism Spectrum Disorder
- Being tested
- Compassion Focused Therapy, Ending Self Stigma
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Depression, Borderline Personality Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Focused TherapyBehavioural
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 StigmaBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Compassion Focused Therapy | Experimental | Not described Receives: Behavioral: Compassion Focused Therapy |
| Ending Self Stigma | Active comparator | Not described Receives: Behavioral: Ending Self Stigma |
| Treatment As Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
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
Measured: Month 1
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
Measured: Month 2
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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start3 Apr 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698589
- Sponsor's protocol ID
- 8566
- Acronym
- COMPASS
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37309006