Clinical trial NCT05434741: Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
HIV
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Acceptability of the CBT group intervention
timeFrame: 12-week follow-up
measure: Feasibility of the CBT group intervention
timeFrame: 12-week follow-up
Secondary outcomes:
measure: Changes in psychological distress
timeFrame: Baseline and at 12-week follow-up appointments.
measure: Feasibility of the CBT intervention
timeFrame: 12-week follow-up
measure: Feasibility of the CBT intervention
timeFrame: 12-week follow-up
measure: Feasibility of the CBT group intervention
timeFrame: 12-week follow-up
measure: Acceptability of the CBT group intervention
timeFrame: Weekly
Other outcomes:
Locations:
city: Boston
country: United States
facility: One Bowdoin Square, Floor 7
state: Massachusetts
Study officials:
References: