Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
研究概览
简要总结
The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.
详细描述
During the COVID-19 pandemic, up to 81% of adults in the United States experienced worsening mental health. A major cause was the social isolation triggered by the pandemic due to quarantining, loss of family or friends, and loss of work. For individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened, putting them at much higher risk for anxiety and depressive symptoms.
Importantly, people who identify as LGBTQ+ have been particularly affected by the social isolation caused by the pandemic and were already at much higher risk of social isolation, loneliness, and mental illness, including suicidality, before the pandemic. The objective of this R01 fully-powered trial is to examine the effectiveness of a brief acceptance-based behavioral telehealth intervention (ABBT) to improve mental health during the COVID-19 pandemic by strengthening social support among LGBTQ+ individuals.
The aims of this proposal are: (1) to examine the effectiveness of ABBT in reducing mental health morbidity by conducting a fully-powered, RCT (n=240) of ABBT vs. Treatment-as-Usual; and, (2) to examine potential mediators and moderators of ABBT treatment effects. Primary outcomes will be anxiety and depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to recruitment clinic for any type of clinical care
- •Identify as LGBTQ+
- •Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9
- •18 years or older
- •Ability to speak and read English
排除标准
- 未提供
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
时间窗: 39 weeks
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: 39 weeks
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(39 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(39 weeks)