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 Hospital1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
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
否

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

研究组 & 干预措施

CBT Group

Experimental

This 12-week intervention program 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., treatment access and engagement, and multi-morbidity), and b.) increase health-promoting behaviors (e.g., physical activity).

干预措施: Weekly Group Skills (Behavioral)

Information-only Group

Experimental

Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older."

干预措施: One-time Trifold Brochure titled "HIV: 50 Years or Older" (Other)

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

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

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 (1)

Loading locations...

相似试验