Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Acceptability of the CBT group intervention
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Abigail Batchelder, Ph.D., M.P.H.
Principal Investigator, Assistant Professor, Staff Psychologist
Massachusetts General Hospital
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
- •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
Outcomes
Primary Outcomes
Acceptability of the CBT group intervention
Time Frame: 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
Time Frame: 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 Outcomes
- Changes in psychological distress(Baseline and at 12-week follow-up appointments.)
- Feasibility of the CBT intervention(12-week follow-up)
- Acceptability of the CBT group intervention(Weekly)
- Feasibility of the CBT group intervention(12-week follow-up)