ClinicalTrials.gg
RecruitingNCT05698589COMPASSUpdated Aug 19, 2026

COMpassion for Psychiatric Disorders And Self-Stigma

An interventional study of Compassion Focused Therapy and Ending Self Stigma in Bipolar Disorder, Schizophrenia and Depression, sponsored by University Hospital, Strasbourg, France. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 102 studies in Bipolar Disorder with a site in France — 34 open to participants now, 37 under way, 1 of them phase 3. Bipolar Disorder · France.

Planned enrollment
23rd of 77
336 · median 170
Started
2023
with 4 others
No phase
54 of 102
22 open now
Primary completion
2028-03
later than 25 of 36 live
Registered
78th of 102
by date
Lead sponsor
7 of 102
University Hospital, Strasbourg, France

Among the 102 studies in Bipolar Disorder with a site in France, this one is the 23rd largest by planned enrollment of the 77 interventional ones that give a count, is one of 5 that started in 2023, is one of 54 with no phase, reaches primary completion later than 25 of the 36 other live ones, and was the 78th registered.

Bipolar Disorder

1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.

This study's planned enrollment of 336 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Open to participants now

34 of the 102 studies in Bipolar Disorder with a site in France are open now.

All 34 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 203 Bipolar Disorder studies recruiting now, 59 (29%) set no upper age limit and 132 (65%) stop at 75 or younger; 37 take children under 18; 49 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study 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.

03

Conditions studied

  • Bipolar Disorder
  • Schizophrenia
  • Depression
  • Borderline Personality Disorder
  • Autism Spectrum Disorder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  1. Patient in an exclusion period determined by a previous or ongoing study
  2. Patient participating in an interventional study involving psychotherapy or an experimental drug
  3. Patient in acute episode of their disorder according to the CGI Severity score
  4. Patient in a medical emergency or immediate life-threatening situation
  5. 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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
336 participants (estimated)

Study arms

  • Experimental
    Compassion Focused Therapy

    Behavioral: Compassion Focused Therapy

  • Active comparator
    Ending Self Stigma

    Behavioral: Ending Self Stigma

  • No intervention
    Treatment As Usual

Interventions

  • BehavioralCompassion 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.

  • BehavioralEnding 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

06

What researchers measure

Primary outcomes

  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

    Time frame: Day 0

  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

    Time frame: Month 1

  3. 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

    Time frame: Month 2

  4. 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

    Time frame: Month 3

07

Study locations

1 of 7 sites recruiting
  • Pôle de Psychiatrie Adulte, Hôpital Charles Perrens
    Bordeaux, 33076, France
    Not yet recruiting
  • Ch Le Vinatier
    Bron, 69678, France
    Not yet recruiting
  • CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Psychiatrie B
    Clermont-Ferrand, 63003, France
    Not yet recruiting
  • Pôle Hospitalo-Universitaire de Psychiatrie d'adultes et d'addictologie du Grand Nancy, Centre Psychothérapique de Nancy
    Laxou, 54520, France
    Not yet recruiting
  • CHU de Montpellier, Psychiatrie d'adultes, Hôpital la Colombière
    Montpellier, 34295, France
    Not yet recruiting
  • Etablissement Public de Santé Mentale (EPSM) de la Marne, Site Pierre-Briquet, Unité de réhabilitation psychosociale
    Reims, 51100, France
    Not yet recruiting
    • Martina TRAYKOVA- BOGOVA, MD · Contacttraykovam@epsm-mame.fr · 33.3.26.86.86.14
    • Martina TRAYKOVA- BOGOVA, MD · Principal investigator
  • Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Mar 2028, 58 months after the start.

Of 352 non-industry interventional studies with no phase under Bipolar Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 58 months is above that.

Counting every sponsor, half of 354 studies reached it within 37 months; a quarter within 23 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2022
First posted
Jan 26, 2023
StartActual
Apr 3, 2023
Primary completionEst.
Mar 1, 2028
CompletionEst.
Mar 1, 2028
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05698589
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
Apr 3, 2023
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Aug 19, 2026

Study contacts

Luisa Weiner
Contact
weiner@unistra.fr
0033388116312

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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