An interventional study of Free2Be in Minority Stress, sponsored by University of Coimbra. Active, not recruiting at 2 sites in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment
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:
Participants will receive an affirmative mindfulness, acceptance, and self-compassion-based face-to-face group intervention with 13 weekly sessions (Free2Be).
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.
University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 pre-session + 12 sessions
Behavioral: Free2Be
Free2Be is a manualized 13-week face-to-face group intervention for SM individuals with one pre-session and plus 12 intervention sessions. The themes of each session are: Human nature \& Relation with suffering (S1), Emotional regulation \& Multiple selves (S2), Creative hopelessness \& Values (S3), Compassionate attention (S4), Compassionate acceptance (S5), Self-criticism; Compassion \& Flows of compassion (S6), Compassionate imagination; Compassionate self (S7), Early experiences; Stigma and shame; \& Compassionate cognitive desfusion (S8), Compassionate thinking (S9), Difficult emotions: Shame \& Anger (S10), Coming out \& Compassionate behaviour (assertiveness) (S11), Positive emotions \& Preparing for the future (S2).
Stress symptoms assessed by DASS-21
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.
Time frame: 6 months (from Baseline to 3-months follow-up)
Mindfulness assessed by CompACT-18
The subscale Behavioural awareness of the self-report Comprehensive assessment of Acceptance and Commitment Therapy processes - 18 Items (CompACT-18; Francis et al., 2016; Trindade et al., 2021) has 5 items that assess mindful attention to the present moment.
Time frame: 6 months (from Baseline to 3-months follow-up)
Acceptance assessed by CompACT-18
The subscale Openness to experience of the self-report Comprehensive assessment of Acceptance and Commitment Therapy processes - 18 Items (CompACT-18; Francis et al., 2016; Trindade et al., 2021) has 5 items that assess willingness to allow internal experiences without efforts to change it.
Time frame: 6 months (from Baseline to 3-months follow-up)
Self-compassion assessed by CMAS
The Self-compassion scale of the self-report Compassion Motivation and Action Scales (CMAS; Steindl et al., 2021; Matos et al., 2023) has 18 items that assess the intent to be self-compassionate, distress tolerance during own suffering, and behaviours to alleviate this suffering.
Time frame: 6 months (from Baseline to 3-months follow-up)
Stigma consciousness assessed by SCQ-PT
The self-report Stigma Consciousness Questionnaire (SCQ-PT; Pinel, 1999; Seabra, Gato, et al., 2023) has 10 items that assess the extent to which sexual minority individuals focus on feel self-conscious about their stereotyped status.
Time frame: 6 months (from Baseline to 3-months follow-up)
Internalized stigma assessed by LGBIS
The subscale Identity dissatisfaction of the self-report Lesbian, Gay, Bisexual Identity Scale (LGBIS; Mohr \& Kendra, 2011; Oliveira et al., 2012) has 6 items that assess internalized stigma.
Time frame: 6 months (from Baseline to 3-months follow-up)
Shame assessed by SMEISS
The Sexual Minority External and Internal Shame Scale (Manão et al., 2023) has 8 items that assess shame related to sexual orientation.
Time frame: 6 months (from Baseline to 3-months follow-up)
Self-Criticism assessed by FSCRS
The composite measure of Inadequate self and Hated self of the self-report Forms of Self-criticizing/Attacking and Self-reassuring Scale (FSCRS; Gilbert et al., 2004; Castilho et al., 2015) has 14 items that assess the experience of inadequacy and self-dislike when failures and setbacks occur. The use of this composite measure is very common in the assessment of self-criticism. Recent years research in non-clinical samples has favoured a unique global factor of self-criticism considering Inadequate self and Hated self together (Halamová et al., 2019).
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of compassion for other assessed by FCS
The subscale Fear of compassion to others of the self-report Fears of Compassion Scale (FCS; Gilbert et al., 2011; Simões, 2012) has 10 items that assess fears, blocks, and resistances to giving compassion to others.
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of compassion from other assessed by FCS
The subscale Fear of compassion from others of the self-report Fears of Compassion Scale (FCS; Gilbert et al., 2011; Simões, 2012) has 13 items that assess fears, blocks, and resistances to receive compassion.
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of self-compassion assessed by FCS
The subscale Fear for compassion for self of the self-report Fears of Compassion Scale (FCS; Gilbert et al., 2011; Simões, 2012) has 15 items that assess one's fears, blocks, and resistances to self-compassion.
Time frame: 6 months (from Baseline to 3-months follow-up)
Anxiety symptoms assessed by DASS-21
The subscale Anxiety symptoms of the self-report Depression Anxiety Stress Scales (Lovibond \& Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess physical arousal symptoms, panic attacks, and fear.
Time frame: 6 months (from Baseline to 3-months follow-up)
Depressive symptoms assessed by DASS-21
The subscale Depression symptoms of the self-report Depression Anxiety Stress Scales (Lovibond \& Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess symptoms usually associated with negative mood.
Time frame: 6 months (from Baseline to 3-months follow-up)
Social anxiety symptoms assessed by SIAS
The self-report Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998; Pinto-Gouveia \& Salvador, 2001) has 19 items that assess fears of general social interaction.
Time frame: 6 months (from Baseline to 3-months follow-up)
Positive affect (drive system) assessed by ASCAS
The composite measure of Activated positive affect and Relaxed positive affect of the self-report Activation and Safe/Content Affect Scale (ASCAS; Gilbert et al., 2008; Pinto-Gouveia et al., 2008) has 14 items that assess the experience of positive affect associated to resource acquisitions and achievements. This composite measure aligns with theorical affect regulation systems (Gilbert, 2010).
Time frame: 6 months (from Baseline to 3-months follow-up)
Positive affect (soothing system) assessed by ASCAS
The subscale Safe/content positive affect of the self-report Activation and Safe/Content Affect Scale (ASCAS; Gilbert et al., 2008; Pinto-Gouveia et al., 2008) has 4 items that assess the experience of positive affect associated to safeness, caring, and contentment.
Time frame: 6 months (from Baseline to 3-months follow-up)
Negative affect (threat system) assessed by PANAS
The subscale Negative affect of the self-report Positive and Negative Affect Schedule (PANAS; Watson, Clark \& Tellegen, 1988; Galinha \& Pais-Ribeiro, 2005) has 10 items that assess the experience of positive affect associated to detection and protection.
Time frame: 6 months (from Baseline to 3-months follow-up)
Plan to share: No
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University of Coimbra