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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in Portugal

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 groups in NCT06028880
Study groupRoleWhat they receive
Experimental groupExperimental1 pre-session + 12 sessions
Receives: Behavioral: Free2Be

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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.

  1. First posted8 Sep 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Oct 2023 (estimated)

Resources

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)
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 25554721
  • 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.

    PubMed 37197599
  • 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.

    PubMed 37528773
  • 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.

    PubMed 12956539

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.

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