HivAMBRNCT04580082
ADHOC Mindfulness-Based Research
A study testing Mindfulness lessons in people with Hiv and Loneliness, run by Mazonson & Santas Inc. at 1 site in United States.
Trial summary
The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Loneliness, Depression
- What is being tested?
- Mindfulness lessons
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2020to 28 Sep 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ADHOC participant with a score of 4 or higher on the 3-item Loneliness Questionnaire from their ADHOC profile
- Clinical diagnosis of HIV
- Able to read and write in English
- Able and willing to provide online informed consent and complete study activities online
- Access to a smartphone or computer
Who cannot join
- Acute medical problem(s) requiring immediate inpatient treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADHOC Mindfulness-Based Research - An Intervention to Address Loneliness Among Older People Living With HIV
The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).
Read the detailed description
The AMBR Study is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV who are over the age of 50 and enrolled in ADHOC (ClinicalTrials.gov identifier NCT04311554). The intervention consists of 14 mindfulness audio lessons, each approximately 20-minutes long. The mindfulness lessons are designed to develop three core skills: concentration (the ability to maintain focus on present-moment experiences), clarity (the ability to pinpoint exactly what you are experiencing in each moment), and equanimity (openness to experience).
- Conditions
- Hiv, Loneliness, Depression, Anxiety
- Being tested
- Mindfulness lessons
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness lessonsBehavioural
14 lessons on mindfulness, each lasting approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness lessons | Experimental | There are 14 lessons in total, each lasting approximately 20 minutes. Participants will be asked to listen to one lesson per day for 14 consecutive days, but to allow for possible missed days, they will have up to 25 days to complete as many of these 14 lessons as they can. The lessons will be delivered via the internet, and participants can use a variety of devices (e.g. smartphone, desktop computer, laptop computer, tablet) to access them. While the lessons cannot be downloaded, they are available for streaming anytime and anywhere there is an internet connection. Participants are welcome to revisit any lesson they have listened to previously, but are not allowed to "skip ahead" to other lessons until they have completed all preceding lessons. This is done because the lessons build on one another, which means that skipping lessons makes continued participation difficult. We will be able to track each participant's usage pattern and will analyze differences across users. Receives: Behavioral: Mindfulness lessons |
| Delayed-start Mindfulness Lessons | Other | The control group will not receive the intervention until the intervention group has completed lesson listening. During this waiting period, they will receive periodic emails letting them know that their turn to listen to lessons is coming soon.
Once available, the control group will have 25 days to listen to the 14 lessons. Receives: Behavioral: Mindfulness lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
Change in loneliness using the 3-Item Loneliness Questionnaire (3IL). 3IL scores range from 3-9, with higher scores indicating greater loneliness.
Measured: Baseline and follow-up, 25 days
Secondary outcomes (2)
Anxiety
Change in anxiety using the 7-item Generalized Anxiety scale (GAD-7). GAD-7 scores range from 0-21, with higher scores indicating more anxiety.
Measured: Baseline and follow-up, 25 days
Depression
Change in depression using the 10-item Center for Epidemiologic Studies Depression scale (CES-D-10). CES-D-10 scores range from 0-30, with higher scores indicating more depression.
Measured: Baseline and follow-up, 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start21 May 2020
- Primary completion4 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazonson & Santas Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Mazonson, MD, MBA, Principal investigator, Mazonson & Santas Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580082
- Sponsor's protocol ID
- 20017 - 01D
- Acronym
- AMBR
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berko J, Mazonson P, Short D, Karris M, Ehui L, Gutner CA, Spinelli F, Zolopa A. Waitlist-controlled trial of an online intervention to address mental health among older people living with HIV. Antivir Ther. 2023 Dec;28(6):13596535231216311. doi: 10.1177/13596535231216311.
PubMed 38031911
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHOC Mindfulness-Based Research - An Intervention to Address Loneliness Among Older People Living With HIV
- ClinicalTrials.gov ID
- NCT04580082
- Acronym / sponsor ID
- AMBR / 20017 - 01D
- Conditions
- Hiv, Loneliness, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Mazonson & Santas Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 8 Oct 2020 (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.
The AMBR Study (ADHOC Mindfulness-Based Research Study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV over the age of 50. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).
Detailed description
The AMBR Study is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with HIV who are over the age of 50 and enrolled in ADHOC (ClinicalTrials.gov identifier NCT04311554). The intervention consists of 14 mindfulness audio lessons, each approximately 20-minutes long. The mindfulness lessons are designed to develop three core skills: concentration (the ability to maintain focus on present-moment experiences), clarity (the ability to pinpoint exactly what you are experiencing in each moment), and equanimity (openness to experience).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness lessons | Experimental | Behavioral: Mindfulness lessonsThere are 14 lessons in total, each lasting approximately 20 minutes. Participants will be asked to listen to one lesson per day for 14 consecutive days, but to allow for possible missed days, they will have up to 25 days to complete as many of these 14 lessons as they can. The lessons will be delivered via the internet, and participants can use a variety of devices (e.g. smartphone, desktop computer, laptop computer, tablet) to access them. While the lessons cannot be downloaded, they are available for streaming anytime and anywhere there is an internet connection. Participants are welcome to revisit any lesson they have listened to previously, but are not allowed to "skip ahead" to other lessons until they have completed all preceding lessons. This is done because the lessons build on one another, which means that skipping lessons makes continued participation difficult. We will be able to track each participant's usage pattern and will analyze differences across users. |
| Delayed-start Mindfulness Lessons | Other | Behavioral: Mindfulness lessonsThe control group will not receive the intervention until the intervention group has completed lesson listening. During this waiting period, they will receive periodic emails letting them know that their turn to listen to lessons is coming soon. Once available, the control group will have 25 days to listen to the 14 lessons. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ADHOC participant with a score of 4 or higher on the 3-item Loneliness Questionnaire from their ADHOC profile
- Clinical diagnosis of HIV
- Able to read and write in English
- Able and willing to provide online informed consent and complete study activities online
- Access to a smartphone or computer
Key exclusion criteria (1 listed)
- Acute medical problem(s) requiring immediate inpatient treatment
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 |
|---|---|---|
| Mindfulness lessons14 lessons on mindfulness, each lasting approximately 20 minutes. | Behavioural | Delayed-start Mindfulness Lessons, Mindfulness lessons |
Primary outcome
Loneliness
Time frame: Baseline and follow-up, 25 days
Change in loneliness using the 3-Item Loneliness Questionnaire (3IL). 3IL scores range from 3-9, with higher scores indicating greater loneliness.
2 secondary outcomes
Anxiety
Time frame: Baseline and follow-up, 25 days
Depression
Time frame: Baseline and follow-up, 25 days
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 Oct 2020.
- Derived from this study: PubMed 38031911Berko J, Mazonson P, Short D, Karris M, Ehui L, Gutner CA, Spinelli F, Zolopa A. Waitlist-controlled trial of an online intervention to address mental health among older people living with HIV. Antivir Ther. 2023 Dec;28(6):13596535231216311. doi: 10.1177/13596535231216311.
- Individual participant dataSharing planned: No
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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.
Peter Mazonson, MD, MBA principal investigator
Mazonson & Santas Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness lessons in people with Hiv and Loneliness, run by Mazonson & Santas Inc. 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 5 inclusion and 1 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 Oct 2020. 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?
Loneliness (time frame: Baseline and follow-up, 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580082, which also lists 1 linked publication.
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 Oct 2020.