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Recruiting NCT05698589

NCT05698589 COMpassion for Psychiatric Disorders And Self-Stigma

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Clinical Trial Summary
NCT ID NCT05698589
Status Recruiting
Phase
Sponsor University Hospital, Strasbourg, France
Condition Bipolar Disorder
Study Type INTERVENTIONAL
Enrollment 336 participants
Start Date 2023-04-03
Primary Completion 2028-03-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Compassion Focused TherapyEnding Self Stigma

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 336 participants in total. It began in 2023-04-03 with a primary completion date of 2028-03-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Luisa Weiner

✉ weiner@unistra.fr

📞 0033388116312

Frequently Asked Questions

Who can join the NCT05698589 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05698589 currently recruiting?

Yes, NCT05698589 is actively recruiting participants. Contact the research team at weiner@unistra.fr for enrollment information.

Where is the NCT05698589 trial being conducted?

This trial is being conducted at Bordeaux, France, Bron, France, Clermont-Ferrand, France, Laxou, France and 3 additional locations.

Who is sponsoring the NCT05698589 clinical trial?

NCT05698589 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 336 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology