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

Stress Reaction Clinical Trial

Official title:

Dating and Sexual Violence Among Sexual Minority Women Living in Central New York (Project DAWN), Study B: Pilot RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949060
• Other study ID #: 20-342 Study B
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Syracuse University
• Contact: Emily Helminen
• Phone: 906-281-3663
• Email: ehelmine[@]syr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compassion
• Fractures, Stress
• Sexuality
• Stress Reaction

Intervention

Behavioral:
• Compassion Intervention
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.

Locations

Country	Name	City	State
United States	Syracuse University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse University	GLMA: Health Professionals Advancing LGBTQ+ Equality

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
Primary	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.	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)
Primary	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.	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)
Primary	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.	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)
Primary	Change in Subjective Stress	Subjective stress reactivity will be measured with the six item State-Trait Anxiety Inventory (Marteau & Bekker, 1993), the Positive and Negative Affect Schedule (PANAS), 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.	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	Change in PTSD Symptoms	PTSD symptoms will be measured using the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2015). Possible scores on the PDS-5 range from 0 to 80. Higher scores indicate more PTSD symptoms.	Baseline, Follow-Up (1-month)
Secondary	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.	Baseline, Follow-Up (1-month)
Secondary	Change in Dissociation	Change in dissociation will be measured with the five items adapted from scales which measure state dissociation in experience sampling studies (Mason et al., 2017; Vine et al., 2020). Dissociation will be measured before and after the intervention and before and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt. Possible scores for this measure range from 0 to 15. Higher scores indicate more dissociation.	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	Change in Craving	Change in craving be measured with the 12-item Alcohol Craving Questionnaire - short form - revised (Singleton et al., 1994). Craving will be measured before and after the intervention and before and after participants undergo the Trier Social Stress Test (TSST) modified with a minority stress prompt. Possible scores on this measure range from 12 to 84. Higher scores indicate more alcohol craving.	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)