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

NCT05434741 | Completed

• 2 other identifiers: 2022P0012242022A000527
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Aging; HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes in psychological distress

  Baseline and at 12-week follow-up appointments.

• Feasibility of the CBT intervention

  12-week follow-up

• Feasibility of the CBT intervention

  12-week follow-up

• Feasibility of the CBT group intervention

  12-week follow-up

• Acceptability of the CBT group intervention

  Weekly

Study Arms (2)

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).

Behavioral: Weekly Group Skills

Information-only Group

EXPERIMENTAL

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"

Interventions

Weekly Group Skills BEHAVIORAL

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.

CBT Group

One-time Trifold Brochure titled "HIV: 50 Years or Older" OTHER

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.

Information-only Group

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ with an undetectable test result within the last 12 months; willing to provide printed or online version of test result for confirmation
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

One Bowdoin Square, Floor 7

Boston, Massachusetts, 02114, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, Staff Psychologist

Model Details: This study is a pilot randomized controlled trial, which will include 50 older people with HIV. Each block (n = 4) will be 1:1 randomized to either the group intervention or information-only control.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: June 20, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 28, 2025
• Last Updated: December 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)