Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV (CHAMP)
Primary Purpose
Aging, HIV
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Group Skills
One-time Trifold Brochure titled "HIV: 50 Years or Older"
Sponsored by
About this trial
This is an interventional supportive care trial for Aging
Eligibility Criteria
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
Sites / Locations
- One Bowdoin Square, Floor 7
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CBT Group
Information-only Group
Arm Description
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).
Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older."
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
Feasibility of the CBT intervention
Feasibility data will consist of effort required to recruit the sample (e.g., number of staff members).
Feasibility of the CBT intervention
Feasibility data will consist of numbers of screenings conducted.
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.
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.
Full Information
NCT ID
NCT05434741
First Posted
June 17, 2022
Last Updated
June 29, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05434741
Brief Title
Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
Acronym
CHAMP
Official Title
Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, HIV
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Information-only Group
Arm Type
Experimental
Arm Description
Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older."
Intervention Type
Behavioral
Intervention Name(s)
Weekly Group Skills
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
One-time Trifold Brochure titled "HIV: 50 Years or Older"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the CBT group intervention
Description
Acceptability will be assessed with a satisfaction evaluation survey previously used with similar samples, modeled after the Client Satisfaction Questionnaire (CSQ-8).
Time Frame
12-week follow-up
Title
Feasibility of the CBT group intervention
Description
Feasibility data will consist of attendance patterns. Feasibility of assessment will be the completion of at least 75% of scheduled group sessions.
Time Frame
12-week follow-up
Secondary Outcome Measure Information:
Title
Changes in psychological distress
Description
Investigators will administer the General Distress Screener - K10. Scores range from 10-50 and higher scores indicate greater likelihood of mental illness.
Time Frame
Baseline and at 12-week follow-up appointments.
Title
Feasibility of the CBT intervention
Description
Feasibility data will consist of effort required to recruit the sample (e.g., number of staff members).
Time Frame
12-week follow-up
Title
Feasibility of the CBT intervention
Description
Feasibility data will consist of numbers of screenings conducted.
Time Frame
12-week follow-up
Title
Feasibility of the CBT group intervention
Description
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.
Time Frame
12-week follow-up
Title
Acceptability of the CBT group intervention
Description
Investigators will administer weekly surveys to assess acceptability among participants in the group skills intervention. This survey consists of 4 items assessing content perception.
Time Frame
Weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
One Bowdoin Square, Floor 7
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
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