ADHOC Mindfulness-Based Research (AMBR)

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).

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Hiv; Loneliness
• Intervention / Treatment: Behavioral: Mindfulness lessons

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 Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Larkspur, California, United States, 94939
      • Mazonson & Santas Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness lessons; 14 lessons on mindfulness, each lasting approximately 20 minutes.
Other: 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.	Behavioral: Mindfulness lessons; 14 lessons on mindfulness, each lasting approximately 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mazonson & Santas Inc.
• Investigators: Principal Investigator: Peter Mazonson, MD, MBA, Mazonson & Santas Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20017 - 01D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No