Affirmative Mindfulness, Acceptance, and Compassion-based Intervention for SM

NCT ID: NCT06028880

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Minority Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

1 pre-session + 12 sessions

Group Type EXPERIMENTAL

Free2Be

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Coimbra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Seabra

Daniel Seabra (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Seabra

Role: PRINCIPAL_INVESTIGATOR

University of Coimbra

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Psychology and Educational Science

Coimbra, , Portugal

Site Status

Serviços De Acção Social Da Universidade De Coimbra

Coimbra, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25554721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37197599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37528773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12956539 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SFRH/BD/143437/2019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Free2Be_intervention_SM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.