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Effects of Self-Compassion Practice on Stress Reactivity Among Sexual Minority Women

Primary Purpose

Stress Reaction, Sexuality, Compassion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compassion Intervention
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Reaction focused on measuring compassion, stress reactivity, sexual minority, gender minority

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be 18 years of age or older Be fluent in English (i.e., speak and read English) Have Internet access Have a working email address Self-identify sexual identity as LGBQ+ or another non-heterosexual identity AND gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity Currently live in Central NY Exclusion Criteria: Failing an inclusion criterion Report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months Report being currently pregnant Report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage Report being on blood pressure medication Have resting systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Compassion Intervention

    No Training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Blood Pressure
    Systolic and diastolic blood pressure will be measured with an Omron ocillometric blood pressure monitoring device before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Change in Salivary Cortisol
    Salivary cortisol levels will be collected using Salimetrics saliva swabs before the intervention and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Change in Heart Rate Variability
    Heart rate variability will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Change in Heart Rate
    Heart rate will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Change in Skin Conductance
    Skin conductance reactivity will be measured with the BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Change in Subjective Stress
    Subjective stress reactivity will be measured with the six item State-Trait Anxiety Inventory (Marteau & Bekker, 1993) and three visual analog scales before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.

    Secondary Outcome Measures

    Change in PTSD Symptoms
    PTSD symptoms will be measured using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2015).
    Change in Substance Use
    Past 30-day substance use, including number of days of any alcohol use, hazardous drinking, cannabis use, prescription drug use, cigarette use, and other drug use was measured using questions from the 2020 National Survey on Drug Use and Health.

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    July 14, 2023
    Sponsor
    Syracuse University
    Collaborators
    GLMA: Health Professionals Advancing LGBTQ+ Equality
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05949060
    Brief Title
    Effects of Self-Compassion Practice on Stress Reactivity Among Sexual Minority Women
    Official Title
    Dating and Sexual Violence Among Sexual Minority Women Living in Central New York (Project DAWN), Study B: Pilot RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Syracuse University
    Collaborators
    GLMA: Health Professionals Advancing LGBTQ+ Equality

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project will test the ability of brief self-compassion training to attenuate physiological and subjective responses to induced stress among sexual minority women, transgender people, and nonbinary people.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Reaction, Sexuality, Compassion
    Keywords
    compassion, stress reactivity, sexual minority, gender minority

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Compassion Intervention
    Arm Type
    Experimental
    Arm Title
    No Training
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Compassion Intervention
    Intervention Description
    The compassion intervention is a single-session 40-min intervention in which the participants practiced soothing rhythm breathing (i.e., they are directed to slow their breathing using a five-count inhale and five-count exhale). They will then be provided didactic instruction on compassion, and will then be guided through an experiential compassion practice adapted that encompasses cultivating feelings of compassion for a loved one and then for oneself.
    Primary Outcome Measure Information:
    Title
    Change in Blood Pressure
    Description
    Systolic and diastolic blood pressure will be measured with an Omron ocillometric blood pressure monitoring device before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Title
    Change in Salivary Cortisol
    Description
    Salivary cortisol levels will be collected using Salimetrics saliva swabs before the intervention and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Title
    Change in Heart Rate Variability
    Description
    Heart rate variability will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Title
    Change in Heart Rate
    Description
    Heart rate will be measured with BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Title
    Change in Skin Conductance
    Description
    Skin conductance reactivity will be measured with the BIOPAC MP160 System before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Follow-Up (40 minutes after Baseline), During TSST (45-50 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Title
    Change in Subjective Stress
    Description
    Subjective stress reactivity will be measured with the six item State-Trait Anxiety Inventory (Marteau & Bekker, 1993) and three visual analog scales before and after the intervention and before during and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt.
    Time Frame
    Baseline, Immediate Follow-Up (40 minutes after Baseline), Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
    Secondary Outcome Measure Information:
    Title
    Change in PTSD Symptoms
    Description
    PTSD symptoms will be measured using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2015).
    Time Frame
    Baseline, Follow-Up (1-month)
    Title
    Change in Substance Use
    Description
    Past 30-day substance use, including number of days of any alcohol use, hazardous drinking, cannabis use, prescription drug use, cigarette use, and other drug use was measured using questions from the 2020 National Survey on Drug Use and Health.
    Time Frame
    Baseline, Follow-Up (1-month)

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Participants who identify as cisgender sexual minority women, transgender, or nonbinary people will be eligible.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be 18 years of age or older Be fluent in English (i.e., speak and read English) Have Internet access Have a working email address Self-identify sexual identity as LGBQ+ or another non-heterosexual identity AND gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity Currently live in Central NY Exclusion Criteria: Failing an inclusion criterion Report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months Report being currently pregnant Report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage Report being on blood pressure medication Have resting systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emily Helminen
    Phone
    906-281-3663
    Email
    ehelmine@syr.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Self-Compassion Practice on Stress Reactivity Among Sexual Minority Women

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