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

NCT06028880 | Unknown

• 2 other identifiers: Free2Be_intervention_SMSFRH/BD/143437/2019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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).

Conditions

Minority Stress

Keywords

Affirmative group intervention; Sexual Minorities; mindfulness; acceptance; compassion; stress; minority stress

Outcome Measures

Primary Outcomes (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.

  6 months (from Baseline to 3-months follow-up)

Secondary Outcomes (16)

• Mindfulness assessed by CompACT-18

  6 months (from Baseline to 3-months follow-up)

• Acceptance assessed by CompACT-18

  6 months (from Baseline to 3-months follow-up)

• Self-compassion assessed by CMAS

  6 months (from Baseline to 3-months follow-up)

• Stigma consciousness assessed by SCQ-PT

  6 months (from Baseline to 3-months follow-up)

• Internalized stigma assessed by LGBIS

  6 months (from Baseline to 3-months follow-up)

Study Arms (1)

Experimental group

EXPERIMENTAL

1 pre-session + 12 sessions

Behavioral: Free2Be

Interventions

Free2Be 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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Majority (\> 18 years old)
• Nonheterosexual self-identified
• Being Portuguese
• Perfectly understanding of Portuguese oral and written language
• Gave informed and free consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (2)

Faculty of Psychology and Educational Science

Coimbra, 3000-115, Portugal

Location

Serviços De Acção Social Da Universidade De Coimbra

Coimbra, 3000-504, Portugal

Location

Related Publications (4)

• 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.

  PMID: 25554721 BACKGROUND

• 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.

  PMID: 37197599 BACKGROUND

• 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.

  PMID: 37528773 BACKGROUND

• 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.

  PMID: 12956539 BACKGROUND

Study Officials

• Daniel Seabra

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Seabra (Principal Investigator)

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: January 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)