Developing a Resilience Intervention for Older, HIV-Infected Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures
研究概览
简要总结
This is the second phase of a two-part study. In the first phase (Protocol ID: R34AT009170), the investigators refined and piloted the Relaxation Response Resiliency (3RP) intervention for women age 50 and over who are living with HIV, a group especially burdened by stressors related both to aging and to living with chronic disease. In this part of the study, the investigators will use data from the first phase to further adapt the intervention manual, and test the final product via a small randomized controlled trial in the same population.
详细描述
Overview.
This is the second phase of a two-part study. In the first phase (Protocol ID: R34AT009170), the investigators adapted an existing resiliency intervention, the Relaxation Response Resiliency Program (3RP), to the needs of women ages 50 and over who are living with HIV. The investigators conducted preliminary testing of the refined group intervention via an open pilot study (N=13 enrolled) across two sites, MGH and Boston Medical Center), and conducted individual exit interviews to solicit feedback on the intervention. Based on these qualitative data, as well as qualitative work conducted previously with this population, the goal of this phase of the project is to conduct a small, randomized pilot of the intervention in groups of up to 10 women with HIV (total N=up to 60) to assess feasibility and acceptability of all study procedures.
Study Procedures.
Participants will be women living with HIV (N=up to 60) age 50 or over, who are recruited via flyers and provider referral from Boston area hospitals and health care settings, as well as community organizations serving individuals living with HIV. Once an individual expresses interest in the study, they will be screened by a study staff member, either by phone or in person, in order to assess study eligibility. Eligible and interested individuals will be invited to sign informed consent and complete an in-person baseline assessment. Participants will be randomized to either a 10-week intervention group (adapted 3RP intervention) or a 10-week control group (supportive psychotherapy program). Participants will then complete a post-treatment assessment, an individual in-depth exit interview to provide feedback on their experience in the study, and a 3-month follow-up assessment. Data from this second phase of the study will inform the eventual development of a full-scale randomized controlled trial.
Adapted 3RP Intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biologically born women who endorse a female identity
- •living with HIV/AIDS
- •age 50 or older
- •English-speaking
排除标准
- •presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g., bipolar disorder, schizophrenia, substance abuse)
- •have participated in a structured cognitive behavioral therapy and/or a mind-body intervention in the past year
结局指标
主要结局
Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures
时间窗: Assessed up to 6 months post-baseline
Investigators assessed feasibility of study procedures by tracking the time it takes for participants to complete each assessment. These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.
Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions
时间窗: Assessed up to 3 months post-baseline
Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating.
Feasibility as Assessed by Reasons for Withdrawing From the Study
时间窗: Assessed up to 6 months post-baseline
Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing.
Feasibility as Assessed by Participants Lost to Follow-Up
时间窗: Assessed up to 6 months post-baseline
Includes the number of individuals who were lost to follow-up and unable to be traced (N=5).
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study
时间窗: Assessed at screening (pre-baseline)
Investigators assessed feasibility of study procedures by tracking the number of potential participants screened and eligible for participation. These metrics were assessed together with the number of eligible individuals enrolled, and the number of assessments completed in order to provide a comprehensive understanding of the feasibility of this study.
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
时间窗: Assessed up to 6 months post-baseline
Investigators assessed feasibility of study procedures by tracking the number of eligible participants enrolled, and the number of treatment, assessment, and make-up sessions completed by all enrolled participants. These metrics were assessed together with the number of individuals screened and eligible in order to provide a comprehensive understanding of the feasibility of this study.
Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment
时间窗: Assessed after completion of all baseline assessments
Investigators assessed feasibility of study procedures by tracking the time it takes to screen and enroll participants, as measured by the number of months it took to recruit, screen, and schedule a baseline assessment for all 44 participants, compared to the number of months we estimated it would take to enroll our target number of participants at the outset of the study (11 months). These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.
Feasibility as Assessed by Reasons for Declining Enrollment
时间窗: Assessed at screening (pre-baseline)
Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining.
Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire
时间窗: Assessed up to 6 months post-baseline
Investigators assessed acceptability at the post-treatment visit using the eight-item Client Satisfaction Questionnaire (CSQ-8), a measure of how much an individual values a treatment. Items are summed to create an overall score; scores range from 8 to 32, with higher scores indicating higher satisfaction. Excellent acceptability was defined a priori as CSQ-8 scores between 26 and 32, and good acceptability was defined a priori as CSQ-8 scores between 20 and 25.
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire
时间窗: Assessed up to 6 months post-baseline
Investigators assessed acceptability at the post-treatment visit by asking participants about their perceptions of the burden of the study assessment battery on a scale from 1 ("no/minimal burden") to 10 ("too much of a burden"). Items are summed to create an overall score; scores range from 1 to 10, with lower scores indicating higher satisfaction.
次要结局
未报告次要终点
研究者
Christina Psaros
Assistant Professor of Psychology
Massachusetts General Hospital