Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV (CHAMP)

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

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).

Study Overview

• Status: Completed
• Conditions: HIV; Aging
• Intervention / Treatment: Behavioral: Weekly Group Skills; Other: One-time Trifold Brochure titled "HIV: 50 Years or Older"

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • One Bowdoin Square, Floor 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-HIV-

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT Group; 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).	Behavioral: Weekly Group Skills; The topics covered in group CBT sessions are: 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.
Experimental: Information-only Group; Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older."	Other: One-time Trifold Brochure titled "HIV: 50 Years or Older"; Participants in the education only group will receive a one-time trifold brochure titled "HIV: 50 Years or Older. This brochure contains information on the prevalence of HIV among people aged 50 and older, defines medication adherence and drug resistance, encourages physical activity and proper nutrition, and addresses the health risk behavior of tobacco-smoking for people living with HIV. Participants receive one brochure in the information-only group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the CBT group intervention	Acceptability will be assessed with a satisfaction evaluation survey previously used with similar samples, modeled after the Client Satisfaction Questionnaire (CSQ-8).	12-week follow-up
Feasibility of the CBT group intervention	Feasibility data will consist of attendance patterns. Feasibility of assessment will be the completion of at least 75% of scheduled group sessions.	12-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in psychological distress	Investigators will administer the General Distress Screener - K10. Scores range from 10-50 and higher scores indicate greater likelihood of mental illness.	Baseline and at 12-week follow-up appointments.
Feasibility of the CBT intervention	Feasibility data will consist of effort required to recruit the sample (e.g., number of staff members).	12-week follow-up
Feasibility of the CBT intervention	Feasibility data will consist of numbers of screenings conducted.	12-week follow-up
Feasibility of the CBT group intervention	Feasibility data will consist of the proportion of the sample eligible to participate to participants who agree to enroll. Feasibility of recruitment will be an enrollment rate equal to or greater than 70% of those who are eligible.	12-week follow-up
Acceptability of the CBT group intervention	Investigators will administer weekly surveys to assess acceptability among participants in the group skills intervention. This survey consists of 4 items assessing content perception.	Weekly

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2022P001224; 2022A000527 (Other Grant/Funding Number: The Mongan Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No