ADHOC Mindfulness-Based Research

Depression Clinical Trial

— AMBR  

Official title:

ADHOC Mindfulness-Based Research - An Intervention to Address Loneliness Among Older People Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580082
• Other study ID #: 20017 - 01D
• Status: Completed
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: October 2020
• Source: Mazonson & Santas Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It is a substudy of the ADHOC study (ClinicalTrials.gov identifier NCT04311554).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 28, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Hiv
• Loneliness

Intervention

Behavioral:
• Mindfulness lessons
14 lessons on mindfulness, each lasting approximately 20 minutes.

Locations

Country	Name	City	State
United States	Mazonson & Santas Inc	Larkspur	California

Sponsors (1)

Lead Sponsor	Collaborator
Mazonson & Santas Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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