ADHOC Mindfulness-Based Research

Not Applicable

Completed

• Conditions: Loneliness; Hiv; Depression; Anxiety

• Registration Number: NCT04580082
• Lead Sponsor: Mazonson & Santas Inc.

Brief 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. 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 Timeline

• Study Start: 2020-05-21
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-28
• Study First Submitted: 2020-09-28
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loneliness	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	Baseline and follow-up, 25 days	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.
Depression	Baseline and follow-up, 25 days	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.

Trial Locations

Locations (1)

Mazonson & Santas Inc; 🇺🇸 Larkspur, California, United States