CHAMP: Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Acceptability of the CBT group intervention [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 [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.
Secondary Outcome Measures
- Changes in psychological distress [Baseline and at 12-week follow-up appointments.]
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 [12-week follow-up]
Feasibility data will consist of effort required to recruit the sample (e.g., number of staff members).
- Feasibility of the CBT intervention [12-week follow-up]
Feasibility data will consist of numbers of screenings conducted.
- Feasibility of the CBT group intervention [12-week follow-up]
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 [Weekly]
Investigators will administer weekly surveys to assess acceptability among participants in the group skills intervention. This survey consists of 4 items assessing content perception.
Eligibility Criteria
Criteria
Inclusion Criteria:
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HIV+ with an undetectable test result within the last 12 months; willing to provide printed or online version of test result for confirmation
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50 years of age or older
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On effective ART; willing to provide ART-related health records or prescriptions for confirmation
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Fluent in English (speaking and reading)
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Willing and able to provide informed consent
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Psychiatrically stable based on clinical interview
Exclusion Criteria:
-HIV-
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Unable to provide undetectable HIV test result within the last 12 months
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Not on effective ART
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<50 years old
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Unable to read and write in English
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Unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | One Bowdoin Square, Floor 7 | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022P001224
- 2022A000527