Clinical trial NCT05949060: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Reaction
Sexuality
Compassion
Keywords: compassion
stress reactivity
sexual minority
gender minority
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: GLMA: Health Professionals Advancing LGBTQ+ Equality
First posted: 2023-07-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: 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)
measure: Change in Salivary Cortisol
timeFrame: Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
measure: Change in Heart Rate Variability
timeFrame: 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)
measure: Change in Heart Rate
timeFrame: 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)
measure: Change in Skin Conductance
timeFrame: 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)
measure: Change in Subjective Stress
timeFrame: 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 outcomes:
measure: Change in PTSD Symptoms
timeFrame: Baseline, Follow-Up (1-month)
measure: Change in Substance Use
timeFrame: Baseline, Follow-Up (1-month)
measure: Change in Dissociation
timeFrame: 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)
measure: Change in Craving
timeFrame: 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)
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References: