AgingCHAMPNCT05434741
Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
A study testing Weekly Group Skills and One-time Trifold Brochure titled "HIV: 50 Years or Older" in people with Aging and HIV, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- What is being tested?
- Weekly Group Skills and One-time Trifold Brochure titled "HIV: 50 Years or Older"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
United States1 site
One Bowdoin Square, Floor 7
Boston, Massachusetts, 02114
About this study
Official title: Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
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).
Read the 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.
- Being tested
- Weekly Group Skills, One-time Trifold Brochure titled "HIV: 50 Years or Older"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Group SkillsBehavioural
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.
One-time Trifold Brochure titled "HIV: 50 Years or Older"Other
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT Group | Experimental | 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). Receives: Behavioral: Weekly Group Skills |
| Information-only Group | Experimental | Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older." Receives: Other: One-time Trifold Brochure titled "HIV: 50 Years or Older" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-week follow-up
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.
Measured: 12-week follow-up
Secondary outcomes (5)
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.
Measured: Baseline and at 12-week follow-up appointments.
Feasibility of the CBT intervention
Feasibility data will consist of effort required to recruit the sample (e.g., number of staff members).
Measured: 12-week follow-up
Feasibility of the CBT intervention
Feasibility data will consist of numbers of screenings conducted.
Measured: 12-week follow-up
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.
Measured: 12-week follow-up
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.
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start20 Jun 2022
- Primary completion1 Dec 2023
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Batchelder, Ph.D., M.P.H., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434741
- Sponsor's protocol ID
- 2022P001224
- Other IDs
- 2022A000527
- Acronym
- CHAMP
- Status last verified
- Dec 2024
- First submitted
- 17 Jun 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Cognitive Behavioral Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV
- ClinicalTrials.gov ID
- NCT05434741
- Acronym / sponsor ID
- CHAMP / 2022P001224
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT Group | Experimental | Behavioral: Weekly Group SkillsThis 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). |
| Information-only Group | Experimental | Other: One-time Trifold Brochure titled "HIV: 50 Years or Older"Participants in the control group will receive a one-time trifold brochure titled "HIV: 50 Years or Older." |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Group SkillsThe 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. | Behavioural | CBT Group |
| 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. | Other | Information-only Group |
Primary outcome
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.
5 secondary outcomes
Changes in psychological distress
Time frame: Baseline and at 12-week follow-up appointments.
Feasibility of the CBT intervention
Time frame: 12-week follow-up
Feasibility of the CBT intervention
Time frame: 12-week follow-up
Feasibility of the CBT group intervention
Time frame: 12-week follow-up
Acceptability of the CBT group intervention
Time frame: Weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Group Skills and One-time Trifold Brochure titled "HIV: 50 Years or Older" in people with Aging and HIV, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the CBT group intervention (time frame: 12-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.