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Clinical Trials/NCT06028880
NCT06028880
Active, not recruiting
Not Applicable

Affirmative Mindfulness, Acceptance, and Compassion-based Group Intervention for Sexual Minorities (Free2Be): A Pilot Study

University of Coimbra2 sites in 1 country28 target enrollmentJanuary 1, 2023
ConditionsMinority Stress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Minority Stress
Sponsor
University of Coimbra
Enrollment
28
Locations
2
Primary Endpoint
Stress symptoms assessed by DASS-21
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Seabra

Daniel Seabra (Principal Investigator)

University of Coimbra

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).

Outcomes

Primary Outcomes

Stress symptoms assessed by DASS-21

Time Frame: 6 months (from Baseline to 3-months follow-up)

The subscale Stress symptoms of the self-report Depression Anxiety Stress Scales (Lovibond \& Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess difficulties in relaxing, nervous excitement, agitation, exaggerated reactions, and impatience.

Secondary Outcomes

  • Self-compassion assessed by CMAS(6 months (from Baseline to 3-months follow-up))
  • Internalized stigma assessed by LGBIS(6 months (from Baseline to 3-months follow-up))
  • Depressive symptoms assessed by DASS-21(6 months (from Baseline to 3-months follow-up))
  • Acceptance assessed by CompACT-18(6 months (from Baseline to 3-months follow-up))
  • Fears of self-compassion assessed by FCS(6 months (from Baseline to 3-months follow-up))
  • Mindfulness assessed by CompACT-18(6 months (from Baseline to 3-months follow-up))
  • Stigma consciousness assessed by SCQ-PT(6 months (from Baseline to 3-months follow-up))
  • Shame assessed by SMEISS(6 months (from Baseline to 3-months follow-up))
  • Fears of compassion for other assessed by FCS(6 months (from Baseline to 3-months follow-up))
  • Anxiety symptoms assessed by DASS-21(6 months (from Baseline to 3-months follow-up))
  • Positive affect (soothing system) assessed by ASCAS(6 months (from Baseline to 3-months follow-up))
  • Self-Criticism assessed by FSCRS(6 months (from Baseline to 3-months follow-up))
  • Negative affect (threat system) assessed by PANAS(6 months (from Baseline to 3-months follow-up))
  • Positive affect (drive system) assessed by ASCAS(6 months (from Baseline to 3-months follow-up))
  • Fears of compassion from other assessed by FCS(6 months (from Baseline to 3-months follow-up))
  • Social anxiety symptoms assessed by SIAS(6 months (from Baseline to 3-months follow-up))

Study Sites (2)

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