跳至主要内容
临床试验/NCT05434741
NCT05434741已完成不适用

Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Acceptability of the CBT group intervention

研究概览

简要总结

In this study, the investigators will assess the feasibility and acceptability of an evidence-based CBT group intervention, developed for older people with HIV, and research methods in a pilot randomized controlled trial including 50 older people with HIV as participants. The evidence-based CBT intervention has been developed and utilized in three clinical groups to date initiated and led by Dr. Batchelder (PI) in the Behavioral Medicine program at MGH. The 12-week intervention program proposed leverages evidence-based traditional and contemporary CBT strategies, with the goal of improving the psychological and physical functioning of older people with HIV by providing education and support to learn strategies to: a.) better manage stressors associated with HIV and aging (e.g., multi-morbidity), and b.) increase health-promoting behaviors (e.g., physical activity).

详细描述

This study is a pilot randomized controlled trial, which will include 50 older people with HIV as participants. Blocks (n = 4) will be 1:1 randomized to either the group intervention or information-only control. The established 12-week group intervention consists of evidence-based traditional and contemporary CBT strategies. Each week will focus on a distinct theme, including: 1.) Domains of Healthy Aging; 2.) Stress and anxiety; 3.) Adherence and Engagement in Primary/Preventative Care; 4.) Depression and Distress; 5.) Physical Activity; 6.) Stigma/Self-Compassion; 7.) Substance Use; 8.) Acceptance of Uncertainty and Uncomfortable Emotions; 9.) Diet; 10.) Behavioral Activation; 11.) Frailty and Memory/Cognition; and 12.) Wrap-Up and Maintaining Gains.

All participants, including those in the intervention group and in the education-only group, will attend virtual baseline and follow-up appointments, complete computerized self-report measures (REDCap) at baseline and follow-up, a structured diagnostic interview at baseline, and a blood draw appointment at baseline and follow-up. Participants in the education-only group will receive a one-time brochure with information on living with HIV, healthy aging, and healthy behaviors when they attend the baseline blood draw appointment.

Aim 1: Assess the feasibility and acceptability of an evidence-based CBT group intervention, developed for older people with HIV, and research methods in a pilot randomized controlled trial (RCT).

Aim 2: Explore changes in a.) inflammation biomarkers (i.e., interleukin-6 [IL-6] and C-reactive protein [CRP]), b.) psychological distress (i.e., general distress, HIV-specific stress, and depressive and anxiety symptoms), and c.) health risk behaviors (i.e., tobacco-smoking, alcohol use, sedentary behaviors, and poor diet quality) in the intervention group versus an education-only group.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV+ with an undetectable test result within the last 12 months; willing to provide printed or online version of test result for confirmation
  • 50 years of age or older
  • On effective ART; willing to provide ART-related health records or prescriptions for confirmation
  • Fluent in English (speaking and reading)
  • Willing and able to provide informed consent
  • Psychiatrically stable based on clinical interview

排除标准

  • Unable to provide undetectable HIV test result within the last 12 months
  • Not on effective ART
  • <50 years old
  • Unable to read and write in English
  • Unable to provide informed consent

结局指标

主要结局

Acceptability of the CBT group intervention

时间窗: 12-week follow-up

Acceptability will be assessed with a satisfaction evaluation survey previously used with similar samples, modeled after the Client Satisfaction Questionnaire (CSQ-8).

Feasibility of the CBT group intervention

时间窗: 12-week follow-up

Feasibility data will consist of attendance patterns. Feasibility of assessment will be the completion of at least 75% of scheduled group sessions.

次要结局

  • Changes in psychological distress(Baseline and at 12-week follow-up appointments.)
  • Acceptability of the CBT group intervention(Weekly)
  • Feasibility of the CBT group intervention(12-week follow-up)
  • Feasibility of the CBT intervention(12-week follow-up)

研究者

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

Abigail Batchelder, Ph.D., M.P.H.

Principal Investigator, Assistant Professor, Staff Psychologist

Massachusetts General Hospital

研究点 (2)

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