Background:
People with mental disorders face frequent stigmatizing attitudes and behaviors from others. Importantly, they can internalize such negative attitudes and thus self-stigmatize. Self-stigma is involved in diminished coping skills leading to social avoidance and difficulties in adhering to care. Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the negative outcomes associated with mental illness. 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. 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. The purpose of this study is to evaluate the efficacy and acceptability of a group-based CFT program on self-stigma, compared to a psychoeducation program for self-stigma (Ending Self-Stigma) and to treatment as usual (TAU). We hypothesize that diminished shame and emotional dysregulation and increased self-compassion will mediate the relationship between self-stigma improvements post-therapy in the experimental group.
Methods:
This seven-center trial will involve 336 participants diagnosed with a severe mental illness and reporting high levels of self-stigma. Participants will be randomized into one of three treatment arms: 12 week-treatment of Compassion-Focused Therapy (experimental arm), 12 week-treatment of Psychoeducation (active control arm), and TAU (treatment as usual - passive control arm). The primary outcome is the decrease of self-stigma scores on a self-report scale, i.e., ISMI, at 12 weeks.
Secondary endpoints include sustainability of self-stigma scores (ISMI) and self-reported scores regarding target psychological dimensions, e.g., shame and emotional regulation, social functioning and psychiatric symptoms. Assessments are scheduled at pretreatment, post-treatment (at 12 weeks), and at 6-month follow-up. Acceptability will be evaluated via (i) the Credibility and Expectancy Questionnaire at T0, the Consumer Satisfaction Questionnaire for Psychotherapeutic Services posttreatment and at 6-month follow-up, (iii) attendance and (iv) dropout rates.
Discussion:
This study will evaluate the potential efficacy and acceptability of a group-based CFT program on the decrease of self-stigma, and thereby contribute to the continuing development of evidence-based therapeutic interventions for the internalized stigma of mental disorders. `
Trial registration:
This trial has been registered on January 26, 2023: clinicaltrials.gov NCT05698589 https://www.clinicaltrials.gov/ct2/show/NCT05698589