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Better Together: A Web-based Relationship Education Tool

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ClinicalTrials.gov Identifier: NCT03953495
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sharon Scales Rostosky, University of Kentucky

Brief Summary:
Health disparities have been documented in same-sex partnered women, including higher rates of cardiovascular disease, Type 2 diabetes, cancers, and mental health disorders. Higher rates of smoking, substance use, and obesity are behavioral risk factors that contribute to these chronic health problems. Living in rural areas with fewer social supports and less access to culturally sensitive healthcare services may also contribute to health disparities in sexual minorities. Their stigmatized identity is linked to minority stress, a well-documented social determinant of health behaviors and outcomes. Coping responses are an important couple-level mechanism that link stigma-related (minority) stress and health in same-sex couples. Relationship education (RE) programming is a potentially effective approach to increasing positive dyadic-level coping skills that support health. In a sample of 40 female same-sex couples, investigators will test the hypothesis that couples who complete newly revised, web-based RE modules that target health-related coping responses to stigma-related stress will report immediate (post-intervention) and persistent (3-month follow up) positive effects on their relationship quality (e.g., positive communication and problem-solving, relationship satisfaction, perceived partner support), stigma-related coping behaviors, and health (e.g., reduced substance use, depression/anxiety, physical health symptoms). This intervention represents one of the first efforts to test the effects of a culturally appropriate web-based relationship education tool that specifically targets health-related coping behaviors in rural female same-sex couples, a stigmatized, high-risk, under-researched and under-resourced population.

Condition or disease Intervention/treatment Phase
Same-Sex Relationships Behavioral: Better Together Behavioral: Better Together (delayed) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BetterTogether: Evaluating the Health Effects of a Culturally Appropriate Web-based Relationship Education Tool That Targets Stigma-related Coping Behaviors in Rural Central Appalachian Female Same-Sex Couples
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Better Together
Participants will be recruited with e-mail, print, and social media announcements and advertisements distributed through the professional contacts and networks of the investigators. The experimental group will consist of randomly assigned volunteers who meet the eligibility requirements (i.e., same-sex female couple over the age of 18 who lives in Central Appalachia).
Behavioral: Better Together
The Better Together Intervention consists of a 7 self-paced online relationship education modules. Following an introductory and overview module couples will complete each of the following together on their web-connected device (computer, ipad, phone). Each module includes didactic material, demonstration vignettes, and guided discussions or skills building exercises. Module 1 focuses on identifying individual and relationship strengths; Module 2 focuses on destructive communication patterns, Module 3 focuses on positive communication skills; Module 4 teaches a problem-solving technique; Module 5 focuses on stress and coping; Module 6 focuses on relationship expectations and commitment, and Module 7 provides a summary of the program. Each module takes approximately 30 minutes to an hour to complete. Metrics will be assessed at baseline, post-intervention, and at a 3 month follow up.

Active Comparator: Better Together delayed
Participants will be recruited with email, print, and social media announcements and advertisements distributed through the professional contacts and networks of the investigators. The wait list control (delayed) group will be randomly assigned volunteers who meet the eligibility requirements (i.e., same-sex female couple over the age of 18 who lives in Central Appalachia). Participants in this group will be provided the same intervention as the experimental group following the delayed start.
Behavioral: Better Together (delayed)
The Better Together (Delayed) Intervention consists of a 7 online relationship education modules. Following an introductory and overview module couples will complete each of the following together on their web-connected device (computer, ipad, phone). Each module includes didactic material, demonstration vignettes, and guided discussions or skills building exercises. Module 1 focuses on identifying individual and relationship strengths; Module 2 focuses on destructive communication patterns, Module 3 focuses on positive communication skills; Module 4 teaches a problem-solving technique; Module 5 focuses on stress and coping; Module 6 focuses on relationship expectations and commitment, and Module 7 provides a summary of the program. Each module takes approximately 30 minutes to an hour to complete. Metrics will be assessed at baseline, pre-intervention, post-intervention, and at a 3 month follow up.




Primary Outcome Measures :
  1. Change in depression and anxiety. [ Time Frame: up to 26 weeks ]
    Change in depression and anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form survey. Eight items measure depression symptom frequency over the past 7 days, and 8 items measure anxiety symptom frequency over the past 7 days. Each item is scored on a scale of 1 to 5 where 1 = never and 5 = always. A low cumulative score indicates low levels of anxiety/depression; a high cumulative score indicates high levels of anxiety/depression.

  2. Health-related Quality of Life [ Time Frame: up to 26 weeks ]
    This scale assesses the number of days out of 30 that the participant experienced poor physical health (0-30), poor mental health (0-30) and the number of days that poor physical or mental health kept them from working (0-30). Scores range from 0-90; lower scores indicating greater health-related quality of life.

  3. Substance Use [ Time Frame: up to 26 weeks ]
    Ten-item scale to assess substance use in the past 30 days. (Cigarette use/smoking: 3 items, Alcohol use (partner and self): 4 items, Marijuana use: 2 items, Prescription painkillers/opiates:1 item). Each item is scored on a frequency scale of 1-7, with 1 indicating less than once per month and 7 indicating more than once per day. Cumulative scores range from 10-70; higher scores indicate increased substance use.

  4. Couples Satisfaction Index [ Time Frame: up to 26 weeks ]
    Twelve-item scale assessing relationship satisfaction. Each item is scored on a scale of 1-7 where 1 = not at all satisfied and 7 = very satisfied. Average scores range from 1-7. An average score of 1 indicates low relationship satisfaction; an average score 7 indicates high relationship satisfaction.

  5. Relationship Instability Index [ Time Frame: up to 26 weeks ]
    Four-item scale assessing relationship instability. Each item is scored on a scale of 0 to 4 where 0 = Never; 1= Once or Twice; 2= Sometimes; 3= Often; 4 = Very Often. Cumulative scores range from 0-16. A cumulative score of 0 indicates low relationship instability; a cumulative score of 16 indicates high levels of relationship instability.

  6. Relationship Confidence [ Time Frame: up to 26 weeks ]
    Ten-item scale assessing relationship confidence. Each item is scored on a scale of 1 to 7 where 1 = Strongly Disagree and 7 = Strongly Agree. Average scores range from 1-7. An average score of 1 indicates low relationship confidence; an average score of 7 indicates high relationship confidence.

  7. Couple Problem Solving [ Time Frame: up to 26 weeks ]
    Six-item scale assessing couple problem solving. Each item is scored on a scale of 1 to 7 where 1 = Never Happens and 7 = Happens Most of the Time. Average scores range from 1-7. An average score of 1 indicates poor couple problem solving; an average score of 7 indicates good couple problem solving.

  8. Couple Communication [ Time Frame: up to 26 weeks ]
    Two combined subscales (27 items) measure the frequency of constructive and destructive conflict resolution behavior. Each item is scored on a scale of 1-7 where 1= Never Happens and 7 =Happens Most of the Time. Average scores range from 1-7. An average score of 1 indicates high levels of destructive conflict resolution behavior and low levels of constructive resolution behavior; an average score of 7 indicates low levels of destructive conflict resolution behaviors and high levels of constructive resolution behaviors.

  9. Intimate Safety [ Time Frame: up to 26 weeks ]
    Questionnaire (28-items) assessing intimate safety. Each item is scored on a scale of 0-4 where 0 = Never and 4 = Always. Average scores range from 0-4. An average score of 0 indicates low levels of intimate safety; an average score of 4 indicates high levels of intimate safety.

  10. Relationship Dedication/Commitment [ Time Frame: up to 26 weeks ]
    Eight-item scale assessing relationship dedication/commitment. Each item is scored on a scale of 1-7 where 1= Strongly Disagree and 7= Strongly Agree. Average scores range from 1-7. An average score of 1 indicates low levels of relationship dedication/commitment; an average score of 7 indicates high levels of relationship dedication/commitment.

  11. Dyadic Coping [ Time Frame: up to 26 weeks ]
    Fifteen-item scale measuring three types of dyadic coping: supportive coping by oneself (5 items), supportive coping of one's partner (5 items), and common dyadic coping (5 items). Each item is scored on a scale of 1-5 where 1= Very Rarely and 5= Very Often. Cumulative scores range from 15-75. A cumulative score of 15 indicates low levels of dyadic coping; a cumulative score of 75 indicates high levels of dyadic coping.

  12. Perceived Relationship Marginalization [ Time Frame: up to 26 weeks ]
    Four-item scale assessing perceived relationship marginalization. Each item is scored on a scale of 1-7 where 1= Very Much Disapproves and 7= Very Much Approves. Cumulative scores range from 4-28. A cumulative score of 4 indicates high levels of perceived relationship marginalization; a cumulative score of 28 indicates low levels of perceived relationship marginalization.

  13. LGB Identity LGB Identity LGB Identity [ Time Frame: up to 26 weeks ]
    Fifteen-item scale assessing feelings of positivity regarding lesbian, gay, or bisexual (LGB) identity. Each item is scored on a scale of 1-7 where 1= Strongly Disagree and 7 = Strongly Agree. Average scores range from 1-7. An average score of 1 indicates negative LGB identity; an average score of 7 indicates positive LGB identity.

  14. Perceived Stress [ Time Frame: up to 26 weeks ]
    Ten-item Cohen Perceived Stress Scale assessing the frequency of perceived stress over the past month. Each item is scored on a scale of 0-4 where 0= Never and 4= Very Often. Cumulative scores range from 0-40. A cumulative score of 0 indicates low perceived stress; a cumulative score of 40 indicates high perceived stress.

  15. Coping Self-Efficacy [ Time Frame: up to 26 weeks ]
    Thirteen-item scale assessing coping self-efficacy (6 problem solving items, 4 emotion-regulation items and 3 social support items). Each item is scored on a scale of 0-10 where 0= Cannot Do At All; 5= Moderately Certain Can Do; 10=Certain Can Do. Cumulative scores range from 0-130. A cumulative score of 0= low coping self-efficacy; a cumulative score of 130 indicates high coping self-efficacy.

  16. Internalized Stigma (Public Identification) [ Time Frame: up to 26 weeks ]
    Seven-item scale assessing public identification. Each item is measured on a scale of 1-7 where 1=Strongly Disagree and 7=Strongly Agree. Average scores range from 1-7. An average score of 1 indicates lower levels of internalized homophobia; an average score of 7 indicates higher levels of internalized homophobia.

  17. Personal Feelings About Identity (Internalized Stigma) [ Time Frame: up to 26 weeks ]
    Eight-item scale assessing public identification. Each item is measured on a scale of 1-7 where 1=Strongly Disagree and 7=Strongly Agree. Average scores range from 1-7. An average score of 1 indicates lower levels of internalized homophobia; an average score of 7 indicates higher levels of internalized homophobia

  18. Mindful Self Care [ Time Frame: up to 26 weeks ]
    Eighteen item scale assessing the frequency of self-care practices in the past 7 days using 3 subscales: physical care (8 items), mindful awareness (4 items) and mindful relaxation (6 items. Each item is scored on a scale of 0-4 where 0=Never (0 days); 1= rarely (1 day); 2= sometimes (2-3 days); 3= often (4-5 days); 4= regularly (6-7 days). On each subscale an average score of 0 indicates low frequency; an average score of 4 indicates high levels of self-care practice. A total score (sum of the subscale averages) of 0 indicates low levels of self-care practice; a score of 4 indicates high levels of self-care practice.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is investigating female same-sex relationships
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • over 18 years old
  • self-identify as same-sex partnered
  • female
  • Central Appalachian resident

Exclusion Criteria:

  • under 18 years old
  • not currently in a committed relationship with a female partner
  • identifies as male
  • identifies as heterosexual
  • has a male partner
  • does not live in Central Appalachia
  • does not have access to the internet and a computer or other device for completing the modules

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953495


Contacts
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Contact: Zak Clements, B.S. 8592577880 zakary.alexander@uky.edu
Contact: Sharon S Rostosky, Ph.D. 8592577880 s.rostosky@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Zakary Clements, B.S.         
Sponsors and Collaborators
Sharon Scales Rostosky
Investigators
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Principal Investigator: Sharon S Rostosky, Ph.D. University of Kentucky

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Responsible Party: Sharon Scales Rostosky, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03953495     History of Changes
Other Study ID Numbers: 17-0427-P4S
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data that underlie reported results published from this trial.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Three years after publication
Access Criteria: Access to data can be requested via email to PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharon Scales Rostosky, University of Kentucky:
stress
stigma-related stress
relationship quality
depressive symptoms
anxiety
couples
intimate relationships
lesbian