跳至主要内容
临床试验/NCT03071887
NCT03071887已完成不适用

Developing a Resilience Intervention for Older, HIV-Infected Women

Massachusetts General Hospital4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
4
主要终点
Number of Participants Completing Treatment Sessions

研究概览

简要总结

The goal of this study is to refine and pilot 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 living with chronic disease. The investigators will adapt the 3RP resiliency intervention to the needs of this population and conduct preliminary testing of the group intervention via an open pilot study.

详细描述

Overview.

Participants will be women living with HIV (N=up to 40) age 50 or over. Women will be recruited from the Boston area. Based on the investigators' qualitative work, the investigators will deliver an adapted version of the 3RP resiliency intervention to groups of 5-8 HIV-infected women age 50 and over. The 3RP intervention will consist of 8-10 weekly sessions of 90 minutes each focused on skills training to build and enhance resilience. The investigators will conduct baseline and post-treatment quantitative assessments, in addition to individual exit interviews to solicit feedback on the intervention. These data will be used to inform the design of a future randomized pilot study.

Study procedures.

Participants (N = up to 40) will be HIV-infected women age 50 or over . Participants will be recruited via study flyers (posted in the infectious disease clinics at local hospitals and in the waiting areas of Boston area community organizations) and provider referral. Once an individual expresses interest in the study, a research assistant will screen that individual to assess study eligibility criteria. Individuals who meet inclusion criteria will be invited to sign informed consent and complete an in-person baseline assessment. Participants will then complete the intervention (described below), a post-treatment assessment, and an individual in-depth exit interview to provide feedback on their experience in the study.

3RP Intervention:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • biologically born women who endorse a female identity
  • HIV-infected
  • 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

研究组 & 干预措施

Intervention

Experimental

Treatment arm - Relaxation Response Resiliency Program (3RP) (this is an open pilot; the treatment arm is the only arm)

干预措施: Relaxation Response Resiliency Program (3RP) (Behavioral)

结局指标

主要结局

Number of Participants Completing Treatment Sessions

时间窗: Approximately 10 weeks after baseline

The investigators will assess feasibility by collecting data on the number of completed treatment sessions.

Participant Satisfaction With Study Procedures

时间窗: Approximately 10 weeks after baseline

Acceptability will be assessed using scores on the Client Satisfaction Questionnaire (CSQ-8). Response options as follows, "Very satisfied", "Mostly satisfied", "Indifferent or mildly dissatisfied", and "Quite dissatisfied".

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Psaros

Assistant Professor of Psychology

Massachusetts General Hospital

研究点 (4)

Loading locations...

相似试验