跳至主要内容
临床试验/NCT03953495
NCT03953495已完成不适用

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

Sharon Scales Rostosky2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Perceived Stress

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Perceived Stress

时间窗: 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.

Substance Use

时间窗: 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.

Couples Satisfaction Index

时间窗: 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.

Relationship Instability Index

时间窗: 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.

Couple Communication

时间窗: 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.

Coping Self-Efficacy

时间窗: 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.

Change in depression and anxiety.

时间窗: 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.

Health-related Quality of Life

时间窗: 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.

Relationship Confidence

时间窗: 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.

Intimate Safety

时间窗: 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.

Personal Feelings About Identity (Internalized Stigma)

时间窗: 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

Couple Problem Solving

时间窗: 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.

Dyadic Coping

时间窗: 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.

Relationship Dedication/Commitment

时间窗: 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.

Perceived Relationship Marginalization

时间窗: 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.

LGB Identity LGB Identity LGB Identity

时间窗: 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.

Internalized Stigma (Public Identification)

时间窗: 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.

Mindful Self Care

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Sharon Scales Rostosky
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sharon Scales Rostosky

Professor

University of Kentucky

研究点 (2)

Loading locations...

相似试验