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NCT Number: NCT05698589

COMpassion for Psychiatric Disorders And Self-Stigma

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.

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Key information

Conditions

Bipolar Disorder Autism Spectrum Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Borderline Personality Disorder Child Development Disorders, Pervasive Depression Mental Disorders Mood Disorders Neurodevelopmental Disorders Personality Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle de Psychiatrie Adulte, Hôpital Charles Perrens, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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

Treatment and study plan

Compassion Focused Therapy

Behavioral

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

Behavioral

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 outcomes

  1. Internalized Stigma of Mental Illness inventory (ISMI)

    Time frame: Day 0

    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

  2. Internalized Stigma of Mental Illness inventory (ISMI)

    Time frame: Month 1

    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

  3. Internalized Stigma of Mental Illness inventory (ISMI)

    Time frame: Month 2

    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

  4. Internalized Stigma of Mental Illness inventory (ISMI)

    Time frame: Month 3

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Luisa Weiner

CONTACT

[email protected]

0033388116312

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: COMPASS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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