NCT05949060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

December 27, 2024

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

May 23, 2023

Last Update Submit

December 20, 2024

Conditions

Stress ReactionSexualityCompassion

Keywords

compassionstress reactivitysexual minoritygender minority

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • Change in PTSD Symptoms

    Baseline, Follow-Up (1-month)

  • Change in Substance Use

    Baseline, Follow-Up (1-month)

  • Change in 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

    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)

Study Arms (2)

Compassion Intervention

EXPERIMENTAL
Behavioral: Compassion Intervention

No Training

NO INTERVENTION

Interventions

Compassion InterventionBEHAVIORAL

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.

Compassion Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants who identify as cisgender sexual minority women, transgender, or nonbinary people will be eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (1)

  • Helminen EC, Behari K, Scheer JR. A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Oct;145:107660. doi: 10.1016/j.cct.2024.107660. Epub 2024 Aug 8.

    PMID: 39121992DERIVED

MeSH Terms

Conditions

Fractures, StressSexuality

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesSexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

July 17, 2023

Study Start

July 17, 2023

Primary Completion

July 29, 2024

Study Completion

September 20, 2024

Last Updated

December 27, 2024

Record last verified: 2023-11

Locations

US(1)