Clinical trial NCT06028880: Affirmative Mindfulness, Acceptance, and Compassion-based Intervention for SM
Official title: Affirmative Mindfulness, Acceptance, and Compassion-based Group Intervention for Sexual Minorities (Free2Be): A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Minority Stress
Keywords: Affirmative group intervention
Sexual Minorities
mindfulness
acceptance
compassion
stress
minority stress
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this pilot clinical trial is to explore the effectiveness of Free2Be group intervention for sexual minorities. The main questions it aims to answer are:

* Is it Free2Be effective in the decrease of stress?
* Are mindfulness, acceptance, and self-compassion responsible for changes in psychological symptoms?

Participants will receive an affirmative mindfulness, acceptance, and self-compassion-based face-to-face group intervention with 13 weekly sessions (Free2Be).

Detailed description: Sexual Minorized (SM) individuals include several self-identified nonheterosexual sexual orientations. This population face uncountable forms of discrimination stemming from social stigma. Unsurprisingly, levels of psychopathology are poorer in SM individuals when compared to heterosexual individuals, The Minority Stress Model describes stress processes that help to explain this disparity, for example, expectations of rejection and internalized stigma. Beyond the specific minority-related processes, general maladaptive psychological processes also contribute to the elevated risk of psychopathology in this population (Psychological Mediation Framework), for example, self-criticism. Additionally, shame and fears of compassion seem to affect the mental health in this population.

When SM individuals try to access mental health care, they find inappropriate and discriminatory services with professionals without specific training on sexuality-related themes. Affirmative interventions are wide approaches with a positive and respectful perspective about sexual orientations, recognizing different identities as representations of human diversity. This approach identifies negative consequences in mental health as consequences of stress related to heterosexism, discrimination and violence against SM individuals.

Previous studies reinforcing the relevance of mindfulness, acceptance, and self-compassion as positive psychological processes for SM individuals. Free2Be was the first affirmative intervention based on mindfulness, acceptance, and compassion techniques for SM individuals, and is a manualized 13 weeks, face-to-face group intervention. The feasibility results highlighted the acceptability of this intervention, suggested some changes in the intervention content, and concluded about the viability of a pilot study.

Eligibility criteria: Inclusion Criteria:

* Majority (\> 18 years old)
* Nonheterosexual self-identified
* Being Portuguese
* Perfectly understanding of Portuguese oral and written language
* Gave informed and free consent

Exclusion Criteria:

* Currently receiving individual or group psychotherapy
* Major Depressive Disorder - severe specifier
* Hypo/maniac Episode - without full remission
* Psychosis Characteristics in the last two months
* Social impairment from Substance Use Disorder
* High suicide risk (according to the Suicide Risk Index).

Primary outcomes:
measure: Stress symptoms assessed by DASS-21
timeFrame: 6 months (from Baseline to 3-months follow-up)
Secondary outcomes:
measure: Mindfulness assessed by CompACT-18
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Acceptance assessed by CompACT-18
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Self-compassion assessed by CMAS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Stigma consciousness assessed by SCQ-PT
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Internalized stigma assessed by LGBIS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Shame assessed by SMEISS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Self-Criticism assessed by FSCRS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Fears of compassion for other assessed by FCS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Fears of compassion from other assessed by FCS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Fears of self-compassion assessed by FCS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Anxiety symptoms assessed by DASS-21
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Depressive symptoms assessed by DASS-21
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Social anxiety symptoms assessed by SIAS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Positive affect (drive system) assessed by ASCAS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Positive affect (soothing system) assessed by ASCAS
timeFrame: 6 months (from Baseline to 3-months follow-up)
measure: Negative affect (threat system) assessed by PANAS
timeFrame: 6 months (from Baseline to 3-months follow-up)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Science
city: Coimbra
country: Portugal
facility: Serviços De Acção Social Da Universidade De Coimbra
Study officials:
affiliation: University of Coimbra
name: Daniel Seabra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pachankis JE. Uncovering Clinical Principles and Techniques to Address Minority Stress, Mental Health, and Related Health Risks Among Gay and Bisexual Men. Clin Psychol (New York). 2014 Dec;21(4):313-330. doi: 10.1111/cpsp.12078.
citation: Helminen EC, Ducar DM, Scheer JR, Parke KL, Morton ML, Felver JC. Self-Compassion, Minority Stress, and Mental Health in Sexual and Gender Minority Populations: A Meta-Analysis and Systematic Review. Clin Psychol (New York). 2023 Mar;30(1):26-39. doi: 10.1037/cps0000104. Epub 2022 Nov 28.
citation: Fowler JA, Buckley L, Muir M, Viskovich S, Paradisis C, Zanganeh P, Dean JA. Digital mental health interventions: A narrative review of what is important from the perspective of LGBTQIA+ people. J Clin Psychol. 2023 Nov;79(11):2685-2713. doi: 10.1002/jclp.23571. Epub 2023 Aug 2.
citation: Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674.