ADHOC Mindfulness-Based Research

NCT ID: NCT04580082

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2020-09-28

Brief Summary

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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).

Detailed Description

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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

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Hiv Loneliness Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness lessons

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.

Group Type EXPERIMENTAL

Mindfulness lessons

Intervention Type BEHAVIORAL

14 lessons on mindfulness, each lasting approximately 20 minutes.

Delayed-start Mindfulness Lessons

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.

Group Type OTHER

Mindfulness lessons

Intervention Type BEHAVIORAL

14 lessons on mindfulness, each lasting approximately 20 minutes.

Interventions

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Mindfulness lessons

14 lessons on mindfulness, each lasting approximately 20 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- Acute medical problem(s) requiring immediate inpatient treatment
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mazonson & Santas Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Mazonson, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Mazonson & Santas Inc.

Locations

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Mazonson & Santas Inc

Larkspur, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38031911 (View on PubMed)

Other Identifiers

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20017 - 01D

Identifier Type: -

Identifier Source: org_study_id

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