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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness lessons | Behavioral | 14 lessons on mindfulness, each lasting approximately 20 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Loneliness | Change in loneliness using the 3-Item Loneliness Questionnaire (3IL). 3IL scores range from 3-9, with higher scores indicating greater loneliness. | Baseline and follow-up, 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and follow-up, 25 days |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
- Acute medical problem(s) requiring immediate inpatient treatment
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| Name | Affiliation | Role |
|---|---|---|
| Peter Mazonson, MD, MBA | Mazonson & Santas Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazonson & Santas Inc | Larkspur | California | 94939 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38031911 | Derived | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
| Baseline and follow-up, 25 days |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |