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
|First Submitted Date ICMJE||May 10, 2019|
|First Posted Date ICMJE||May 16, 2019|
|Last Update Posted Date||June 28, 2019|
|Actual Study Start Date ICMJE||June 25, 2019|
|Estimated Primary Completion Date||December 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03953495 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Better Together: A Web-based Relationship Education Tool|
|Official Title ICMJE||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|
|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.|
Central Appalachian women in same-sex relationships experience health disparities. Higher rates of smoking, other substance use, and obesity are risk factors that contribute to health disparities in Central Appalachia women, and these health risk factors have been also been implicated in the health disparities faced by women who are same-sex partnered. In a national probability sample, lesbian and bisexual young adult women, compared to heterosexual young adult women, reported higher rates of smoking and heavy drinking, had significantly higher BMIs, and were significantly more likely to report an illness in the previous two weeks. The intervention in this pilot study is based on minority stress and relationship theories and current empirical findings reviewed below.
Stigma-related stress, a chronic form of social stress, largely accounts for health disparities.
Stigma affects health by creating conditions of chronic stress in those with stigmatized identities. This chronic (minority) stress has been linked to diminished mental and physical health. Specifically in rural LGB samples, stigma-related stress has been linked to higher levels of psychological distress (e.g., depression and anxiety), increased substance use, and overall poorer physical health, Same-sex couple members experience stigma-related stress because of experiences of discrimination and prejudice that targets them as individuals, as a couple, and, as a stigmatized social identity group. In their daily interactions, Central Appalachian same-sex couples experience discrimination and prejudice at work, in schools and churches, and in their families and communities. Even though same-sex couples in Central Appalachia can legally marry, stigma and discrimination persist. No state law in this region protects same-sex couples from discrimination in services, employment or housing.
The theory of minority stress as applied to LGB individuals describes a psychological process in which chronic experiences of prejudice and discrimination lead to fear and expectations of rejection, concerns about possible consequences of disclosing or concealing one's sexual minority identity or same-sex relationship, and internalized negativity or shame about one's relationship and one's identity. Minority stress among LGB-identified people appears to be on the increase nationally due to recent political events that threaten hard-won progress toward full equality of same-sex partnered individuals and their families.
Coping responses are an important mechanism that links stigma-related stress and health. To manage these chronic stigma-related stressors, LGB individuals use positive and/or negative coping responses that may buffer or exacerbate their effects of these stressors on health. Findings suggest that coping responses are an important mechanism linking stigma-related stress to poorer health outcomes. Therefore, helping this population to cope more effectively with stigma-related stress can buffer its negative health effects.
Same-sex couples share minority stress and strengths. Same-sex couples' relationships can simultaneously be the target of discrimination and prejudice and also the primary source of support for coping with that discrimination and prejudice. Conceptual models based in relationship science and minority stress theory and recent empirical evidence suggests that same-sex couples share minority stress. For example, when one couple member experiences discrimination at work, the minority stress that it triggers also affects the minority stress level of the other couple member. In other cases, the couple relationship itself is the target of discrimination, for instance, when extended family members refuse to accept the couple. Shared minority stress can take a toll on relationship quality unless couples find effective ways to cope. Distressed couples who rely on inadequate or unhealthy coping strategies are at risk for mental and physical health problems.
On the other hand, specific strengths and resiliencies enable same-sex couples to create satisfying and stable relationships even in the context of stigma-related stress. For example, female couples have demonstrated strengths in forming egalitarian partnerships that include sharing responsibility for the emotional climate of the relationship household and a commitment to supporting each other's health-related behaviors. Together these findings suggest the importance of intervening at the dyadic level by using couple-level strengths to enhance relationship skills and positive health-related coping behaviors to address stigma-related (minority) stress. Helping female same-sex couples to develop their relationship skills and use them to cope effectively with stigma-related stress in ways that support each other's health and well-being will help to address mental and physical health disparities in this population.
Relationship education (RE) programming is a potentially effective approach to increasing dyadic-level coping skills that support health-related behavior. Compared to different-sex couples, married/partnered sexual minority women receive less social support for their relationship from their families and communities, and as a result they tend to rely more heavily on their relationship for support. In addition to a lack of family and community support, same-sex couples in Central Appalachia often lack friendship networks that include other same-sex couples who could serve as role models and resources. Thus, Central Appalachia female same-sex couple can benefit from an accessible, evidence-based intervention that supports their relationship well-being, an important foundation for health.
In general, the purpose of RE is to increase knowledge and teach skills that will circumvent the development of severe problems in the future. RE programs have been shown to benefit married and unmarried different-sex couples across racial/ethnic and socio-economic backgrounds by effecting reliable change in communication and relationship satisfaction. Optimal RE programs should be tailored to the specific client population, accessible, grounded in theory and research, and directed at reducing risk factors and increasing protective factors at the individual and couple level. To date, RE programs have been limited to different-sex couples. Yet, prominent RE researchers have proposed the RE approaches that use same-sex couples' relationship skills and strengths to cope effectively with stigma-related stress are well-suited to support the health and well-being of these couples and their families. The current project builds upon and extends an RE workshop for female same-sex couples, which is based in relationship science and minority stress theory and has demonstrated post-intervention effects on relationship quality. In this randomized wait-list control trial, same-sex female couples achieved significant improvement in their relationship quality and communication skills that was maintained three months after the conclusion of the program. However, there was no evidence of program effects on stress or perceived support. Further, participants reported that the units on stress and social support were only somewhat helpful and could benefit from the inclusion of more specific strategies and skills. The current project will build upon and address limitations of previous research by piloting and testing the effectiveness of a revised program that uses newly developed modules to teach couples to use their relationship skills to cope with stigma-related stress in ways that support their long-term health and well-being (Aim 1).
Some evidence suggests that web-based relationship interventions (for different-sex couples) are superior to no treatment. In distressed different-sex couples, a web-based couple intervention significantly improved relationship quality and reduced pre-intervention symptoms of anxiety, depression, and physical health problems when compared to wait-list controls. The current project will extend previous work by adapting the revised RET to a web-based format to make it more accessible to rural female same-sex couples and evaluating feasibility, acceptability, adherence, and satisfaction (Aim 2).
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Same-Sex Relationships|
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||July 2020|
|Estimated Primary Completion Date||December 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03953495|
|Other Study ID Numbers ICMJE||17-0427-P4S|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Sharon Scales Rostosky, University of Kentucky|
|Study Sponsor ICMJE||Sharon Scales Rostosky|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Kentucky|
|Verification Date||June 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP