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

HIV Clinical Trial

— CHAMP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05434741
• Other study ID #: 2022P001224
• Secondary ID: 2022A000527
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• HIV
• Inflammation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	One Bowdoin Square, Floor 7	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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
Secondary	Feasibility of the CBT intervention	Feasibility data will consist of numbers of screenings conducted.	12-week follow-up
Secondary	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
Secondary	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