Minority StressFree2BeNCT06028880
Affirmative Mindfulness, Acceptance, and Compassion-based Intervention for SM
A study testing Free2Be in people with Minority Stress, run by University of Coimbra at 2 sites in Portugal.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minority Stress
- What is being tested?
- Free2Be
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jan 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Majority (> 18 years old)
- Nonheterosexual self-identified
- Being Portuguese
- Perfectly understanding of Portuguese oral and written language
- Gave informed and free consent
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Faculty of Psychology and Educational Science
Coimbra, 3000-115
Serviços De Acção Social Da Universidade De Coimbra
Coimbra, 3000-504
About this study
Official title: Affirmative Mindfulness, Acceptance, and Compassion-based Group Intervention for Sexual Minorities (Free2Be): A Pilot Study
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).
Read the 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.
- Conditions
- Minority Stress
- Being tested
- Free2Be
- Keywords
- Affirmative group intervention, Sexual Minorities, mindfulness, acceptance, compassion, stress, minority stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free2BeBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1 pre-session + 12 sessions Receives: Behavioral: Free2Be |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months (from Baseline to 3-months follow-up)
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months (from Baseline to 3-months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Jan 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Minority StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Seabra, University of Coimbra
- Investigators
- Daniel Seabra, Principal investigator, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028880
- Sponsor's protocol ID
- Free2Be_intervention_SM
- Other IDs
- SFRH/BD/143437/2019
- Acronym
- Free2Be
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25554721Helminen 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.
PubMed 37197599Fowler 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.
PubMed 37528773Meyer 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.
PubMed 12956539
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affirmative Mindfulness, Acceptance, and Compassion-based Group Intervention for Sexual Minorities (Free2Be): A Pilot Study
- ClinicalTrials.gov ID
- NCT06028880
- Acronym / sponsor ID
- Free2Be / Free2Be_intervention_SM
- Conditions
- Minority Stress
- Keywords
- Affirmative group intervention, Sexual Minorities, mindfulness, acceptance, compassion, stress, minority stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Free2Be1 pre-session + 12 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Majority (> 18 years old)
- Nonheterosexual self-identified
- Being Portuguese
- Perfectly understanding of Portuguese oral and written language
- Gave informed and free consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free2BeFree2Be 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). | Behavioural | Experimental group |
Primary outcome
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.
16 secondary outcomes
Mindfulness assessed by CompACT-18
Time frame: 6 months (from Baseline to 3-months follow-up)
Acceptance assessed by CompACT-18
Time frame: 6 months (from Baseline to 3-months follow-up)
Self-compassion assessed by CMAS
Time frame: 6 months (from Baseline to 3-months follow-up)
Stigma consciousness assessed by SCQ-PT
Time frame: 6 months (from Baseline to 3-months follow-up)
Internalized stigma assessed by LGBIS
Time frame: 6 months (from Baseline to 3-months follow-up)
Shame assessed by SMEISS
Time frame: 6 months (from Baseline to 3-months follow-up)
Self-Criticism assessed by FSCRS
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of compassion for other assessed by FCS
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of compassion from other assessed by FCS
Time frame: 6 months (from Baseline to 3-months follow-up)
Fears of self-compassion assessed by FCS
Time frame: 6 months (from Baseline to 3-months follow-up)
Anxiety symptoms assessed by DASS-21
Time frame: 6 months (from Baseline to 3-months follow-up)
Depressive symptoms assessed by DASS-21
Time frame: 6 months (from Baseline to 3-months follow-up)
Social anxiety symptoms assessed by SIAS
Time frame: 6 months (from Baseline to 3-months follow-up)
Positive affect (drive system) assessed by ASCAS
Time frame: 6 months (from Baseline to 3-months follow-up)
Positive affect (soothing system) assessed by ASCAS
Time frame: 6 months (from Baseline to 3-months follow-up)
Negative affect (threat system) assessed by PANAS
Time frame: 6 months (from Baseline to 3-months follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 25554721Pachankis 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.
- Background: PubMed 37197599Helminen 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.
- Background: PubMed 37528773Fowler 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.
- Background: PubMed 12956539Meyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Seabra principal investigator
University of Coimbra
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free2Be in people with Minority Stress, run by University of Coimbra at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress symptoms assessed by DASS-21 (time frame: 6 months (from Baseline to 3-months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028880, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023; AzTrials last refreshed its copy on 2 Nov 2026.