xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06028880</url>
    </required_header>
    <id_info>
      <org_study_id>Free2Be_intervention_SM</org_study_id>
      <secondary_id>SFRH/BD/143437/2019</secondary_id>
      <nct_id>NCT06028880</nct_id>
    </id_info>
    <brief_title>Affirmative Mindfulness, Acceptance, and Compassion-based Intervention for SM</brief_title>
    <acronym>Free2Be</acronym>
    <official_title>Affirmative Mindfulness, Acceptance, and Compassion-based Group Intervention for Sexual Minorities (Free2Be): A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Coimbra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Coimbra</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot clinical trial is to explore the effectiveness of Free2Be group&#xD;
        intervention for sexual minorities. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is it Free2Be effective in the decrease of stress?&#xD;
  &#xD;
          -  Are mindfulness, acceptance, and self-compassion responsible for changes in&#xD;
             psychological symptoms?&#xD;
  &#xD;
        Participants will receive an affirmative mindfulness, acceptance, and self-compassion-based&#xD;
        face-to-face group intervention with 13 weekly sessions (Free2Be).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sexual Minorized (SM) individuals include several self-identified nonheterosexual sexual&#xD;
        orientations. This population face uncountable forms of discrimination stemming from social&#xD;
        stigma. Unsurprisingly, levels of psychopathology are poorer in SM individuals when compared&#xD;
        to heterosexual individuals, The Minority Stress Model describes stress processes that help&#xD;
        to explain this disparity, for example, expectations of rejection and internalized stigma.&#xD;
        Beyond the specific minority-related processes, general maladaptive psychological processes&#xD;
        also contribute to the elevated risk of psychopathology in this population (Psychological&#xD;
        Mediation Framework), for example, self-criticism. Additionally, shame and fears of&#xD;
        compassion seem to affect the mental health in this population.&#xD;
  &#xD;
        When SM individuals try to access mental health care, they find inappropriate and&#xD;
        discriminatory services with professionals without specific training on sexuality-related&#xD;
        themes. Affirmative interventions are wide approaches with a positive and respectful&#xD;
        perspective about sexual orientations, recognizing different identities as representations of&#xD;
        human diversity. This approach identifies negative consequences in mental health as&#xD;
        consequences of stress related to heterosexism, discrimination and violence against SM&#xD;
        individuals.&#xD;
  &#xD;
        Previous studies reinforcing the relevance of mindfulness, acceptance, and self-compassion as&#xD;
        positive psychological processes for SM individuals. Free2Be was the first affirmative&#xD;
        intervention based on mindfulness, acceptance, and compassion techniques for SM individuals,&#xD;
        and is a manualized 13 weeks, face-to-face group intervention. The feasibility results&#xD;
        highlighted the acceptability of this intervention, suggested some changes in the&#xD;
        intervention content, and concluded about the viability of a pilot study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stress symptoms assessed by DASS-21</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The subscale Stress symptoms of the self-report Depression Anxiety Stress Scales (Lovibond &amp; Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess difficulties in relaxing, nervous excitement, agitation, exaggerated reactions, and impatience.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mindfulness assessed by CompACT-18</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptance assessed by CompACT-18</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-compassion assessed by CMAS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stigma consciousness assessed by SCQ-PT</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Internalized stigma assessed by LGBIS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The subscale Identity dissatisfaction of the self-report Lesbian, Gay, Bisexual Identity Scale (LGBIS; Mohr &amp; Kendra, 2011; Oliveira et al., 2012) has 6 items that assess internalized stigma.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shame assessed by SMEISS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The Sexual Minority External and Internal Shame Scale (Manão et al., 2023) has 8 items that assess shame related to sexual orientation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Criticism assessed by FSCRS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fears of compassion for other assessed by FCS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fears of compassion from other assessed by FCS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fears of self-compassion assessed by FCS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety symptoms assessed by DASS-21</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The subscale Anxiety symptoms of the self-report Depression Anxiety Stress Scales (Lovibond &amp; Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess physical arousal symptoms, panic attacks, and fear.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive symptoms assessed by DASS-21</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The subscale Depression symptoms of the self-report Depression Anxiety Stress Scales (Lovibond &amp; Lovibond, 1995; Pais-Ribeiro et al., 2004) has 7 items that assess symptoms usually associated with negative mood.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social anxiety symptoms assessed by SIAS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The self-report Social Interaction Anxiety Scale (SIAS; Mattick &amp; Clarke, 1998; Pinto-Gouveia &amp; Salvador, 2001) has 19 items that assess fears of general social interaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive affect (drive system) assessed by ASCAS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive affect (soothing system) assessed by ASCAS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative affect (threat system) assessed by PANAS</measure>
      <time_frame>6 months (from Baseline to 3-months follow-up)</time_frame>
      <description>The subscale Negative affect of the self-report Positive and Negative Affect Schedule (PANAS; Watson, Clark &amp; Tellegen, 1988; Galinha &amp; Pais-Ribeiro, 2005) has 10 items that assess the experience of positive affect associated to detection and protection.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Minority Stress</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 pre-session + 12 sessions</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Free2Be</intervention_name>
      <description>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 &amp; Relation with suffering (S1), Emotional regulation &amp; Multiple selves (S2), Creative hopelessness &amp; Values (S3), Compassionate attention (S4), Compassionate acceptance (S5), Self-criticism; Compassion &amp; Flows of compassion (S6), Compassionate imagination; Compassionate self (S7), Early experiences; Stigma and shame; &amp; Compassionate cognitive desfusion (S8), Compassionate thinking (S9), Difficult emotions: Shame &amp; Anger (S10), Coming out &amp; Compassionate behaviour (assertiveness) (S11), Positive emotions &amp; Preparing for the future (S2).</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Majority (&gt; 18 years old)&#xD;
  &#xD;
            -  Nonheterosexual self-identified&#xD;
  &#xD;
            -  Being Portuguese&#xD;
  &#xD;
            -  Perfectly understanding of Portuguese oral and written language&#xD;
  &#xD;
            -  Gave informed and free consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently receiving individual or group psychotherapy&#xD;
  &#xD;
            -  Major Depressive Disorder - severe specifier&#xD;
  &#xD;
            -  Hypo/maniac Episode - without full remission&#xD;
  &#xD;
            -  Psychosis Characteristics in the last two months&#xD;
  &#xD;
            -  Social impairment from Substance Use Disorder&#xD;
  &#xD;
            -  High suicide risk (according to the Suicide Risk Index).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Seabra</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Coimbra</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Psychology and Educational Science</name>
        <address>
          <city>Coimbra</city>
          <zip>3000-115</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Serviços De Acção Social Da Universidade De Coimbra</name>
        <address>
          <city>Coimbra</city>
          <zip>3000-504</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>25554721</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>37197599</PMID>
    </reference>
    <reference>
      <citation>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 Aug 2. doi: 10.1002/jclp.23571. Online ahead of print.</citation>
      <PMID>37528773</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>12956539</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Coimbra</investigator_affiliation>
      <investigator_full_name>Daniel Seabra</investigator_full_name>
      <investigator_title>Daniel Seabra (Principal Investigator)</investigator_title>
    </responsible_party>
    <keyword>Affirmative group intervention</keyword>
    <keyword>Sexual Minorities</keyword>
    <keyword>mindfulness</keyword>
    <keyword>acceptance</keyword>
    <keyword>compassion</keyword>
    <keyword>stress</keyword>
    <keyword>minority stress</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06028880
  org study id: Free2Be_intervention_SM
  secondary id: SFRH/BD/143437/2019
  nct id: NCT06028880
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Stress symptoms assessed by DASS-21
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Mindfulness assessed by CompACT-18
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Acceptance assessed by CompACT-18
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Self-compassion assessed by CMAS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Stigma consciousness assessed by SCQ-PT
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Internalized stigma assessed by LGBIS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Shame assessed by SMEISS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: The Sexual Minority External and Internal Shame Scale (Manão et al., 2023) has 8 items that assess shame related to sexual orientation.
  measure: Self-Criticism assessed by FSCRS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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).
  measure: Fears of compassion for other assessed by FCS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Fears of compassion from other assessed by FCS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Fears of self-compassion assessed by FCS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Anxiety symptoms assessed by DASS-21
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Depressive symptoms assessed by DASS-21
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Social anxiety symptoms assessed by SIAS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Positive affect (drive system) assessed by ASCAS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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).
  measure: Positive affect (soothing system) assessed by ASCAS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  measure: Negative affect (threat system) assessed by PANAS
  time frame: 6 months (from Baseline to 3-months follow-up)
  description: 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.
  arm group label: Experimental group
  arm group type: Experimental
  description: 1 pre-session + 12 sessions
  intervention type: Behavioral
  intervention name: Free2Be
  description: 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).
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel Seabra
  role: Principal Investigator
  affiliation: University of Coimbra
  facility: 
  facility: 
  country: Portugal
  citation: 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
  citation: 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
  citation: 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 Aug 2. doi: 10.1002/jclp.23571. Online ahead of print.
  PMID: 37528773
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: University of Coimbra
  investigator full name: Daniel Seabra
  investigator title: Daniel Seabra (Principal Investigator)
  sharing ipd: No