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

December 20, 2024 updated by: Syracuse University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No Training
Experimental: Compassion 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
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)
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)
Change in Salivary Cortisol
Time Frame: Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)
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)
Change in Heart Rate Variability
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)
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)
Change in Heart Rate
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)
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)
Change in Skin Conductance
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)
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)
Change in Subjective Stress
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Substance Use
Time Frame: Baseline, Follow-Up (1-month)
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)
Change in PTSD Symptoms
Time Frame: Baseline, Follow-Up (1-month)
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)
Change in Dissociation
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)
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)
Change in Craving
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Syracuse University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GLMA: Health Professionals Advancing LGBTQ+ Equality

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-342 Study B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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