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Stress ReactionNCT05949060

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

A study testing Compassion Intervention in people with Stress Reaction and Sexuality, run by Syracuse University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress Reaction, Sexuality, Compassion
What is being tested?
Compassion Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
17 Jul 2023to 20 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Syracuse University

    Syracuse, New York, 13244

Other trials in United States

About this study

Official title: 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.

Being tested
Compassion Intervention
Keywords
compassion, stress reactivity, sexual minority, gender minority
Medical subject headings
Fractures, Stress, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion InterventionBehavioural

    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.

Study groups in NCT05949060
Study groupRoleWhat they receive
Compassion InterventionExperimentalNot described
Receives: Behavioral: Compassion Intervention
No TrainingNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: Baseline, Immediate Post-TSST (20-30 minutes post-TSST onset), Recovery Post-TSST (10-20 minutes after Immediate Post-TSST time point)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  1. 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.

    Measured: Baseline, Follow-Up (1-month)

  2. 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.

    Measured: Baseline, Follow-Up (1-month)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start17 Jul 2023
  3. Primary completion29 Jul 2024
  4. Study completion20 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05949060
Sponsor's protocol ID
20-342 Study B
Status last verified
Nov 2023
First submitted
23 May 2023
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39121992

Questions about this trial

What is this clinical trial studying?

A study testing Compassion Intervention in people with Stress Reaction and Sexuality, run by Syracuse University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05949060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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