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NCT Number: NCT04580082

ADHOC Mindfulness-Based Research

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).

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Anxiety Anxiety Disorders Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Loneliness Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mazonson & Santas Inc

Larkspur, California, 94939, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness lessons

Behavioral

14 lessons on mindfulness, each lasting approximately 20 minutes.

Primary outcomes

  1. Loneliness

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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.

  2. Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mazonson & Santas Inc.

Industry

Registry information

Official study title

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

Acronym: AMBR

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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