Health Improvement for Baltimore Youth

NCT ID: NCT02624193

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-06-25

Brief Summary

Preliminary data from the investigators' National Center for Complementary and Alternative Medicine (NCCAM)-funded R21 on mindfulness-based stress reduction (MBSR) in HIV-infected youth suggest an association between mindfulness and improved self-regulation and medication adherence. This randomized, controlled trial will help the investigators to better understand the specific impact of MBSR on HIV medication and treatment adherence in HIV-infected youth, and the efficacy of MBSR in the amelioration of stress and improved self-regulation.

Detailed Description

Despite remarkable advances in HIV medication effectiveness, adherence to HIV treatment recommendations is alarmingly poor, resulting in preventable morbidity and mortality. It is estimated that 26-72% of HIV-infected adolescents are non-adherent to their HIV medications and 22-33% are non-adherent with scheduled health care visits. HIV treatment non-adherence puts individuals at markedly increased risk for illness related to HIV itself and a variety of opportunistic infections, as well as at increased risk of spreading HIV.

Preliminary data from the investigators' NCCAM-funded R21 on mindfulness-based stress reduction (MBSR) in HIV-infected youth suggest an association between mindfulness and improved medication adherence, as well as enhanced self-regulatory processes (coping, psychological function, and cognitive function). This two-armed randomized, controlled trial will help the investigators to better understand the specific impact of MBSR on HIV medication and treatment adherence in HIV-infected youth, and the efficacy of MBSR in the amelioration of stress and improved self-regulation.

The aims of the study are as follows:

Primary Objective

Investigators hypothesize that MBSR vs. active control program (HT) participation will be associated with:

• (H1) Improved HIV medication adherence (self-report validated by HIV viral load) at 3 months, 6 months, and 12 months

Secondary Objectives

Investigators also hypothesize that MBSR vs. active control program (HT) participation will be associated with:

• (H2) Improved coping at 3, 6, and 12 months
• (H3) Improved psychological functioning at 3, 6, and 12 months
• (H4) Improved cognitive functioning at 3, 6, and 12 months

Investigators will also explore:

• associations (and potential mediation) among mindfulness, self-regulation, and HIV medication adherence and
• using qualitative methods, experience with MBSR, HIV treatment adherence, as well as reasons for non-participation in the study and non-attendance of program sessions to inform future implementation planning.
• gender differences in the effects of MBSR versus HT on emotion regulation and physiological responses to stressful stimuli.

Conditions

HIV; Adolescent Development; Adolescent Behavior; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MBSR Program

MBSR Program:

The MBSR intervention is a nine-week program designed to cultivate mindfulness, a focused non-judgmental awareness of the present moment. It consists of eight 2-hour weekly sessions and one 3-hour retreat and the content includes three main components: 1) material related to mindfulness, meditation, yoga, and the mind-body connection; 2) experiential practice of mindful meditation (sitting, lying down, walking), gentle mindful yoga, and "body scan" during group meetings and encouragement of home practice; and 3) group discussion focused on problem-solving related to barriers to effective practice. HIV disease will not be discussed as a group topic, unless it is brought up by participants.

Group Type: EXPERIMENTAL

MBSR Program

Intervention Type: BEHAVIORAL

Mindfulness-based stress reduction, as described previously.

HT Program

Healthy Topics Program:

The health education program "Healthy Topics" (HT) will serve as an attention control group. The HT program is focused on providing age-appropriate health information and education. There is minimal content overlap in the MBSR and HT programs regarding self-care and healthy eating; however, the style, structure, and content of the MBSR and HT programs are distinct. HT participants will receive no training in MBSR or meditation. Topics covered include physical activity, nutrition, managing weight, building health, personal care, understanding adolescence, tobacco, alcohol, and other drugs. HIV disease will not be discussed as a group topic, unless it is brought up by participants.

Group Type: PLACEBO_COMPARATOR

HT Program

Intervention Type: BEHAVIORAL

Health education curriculum, as described previously

Interventions

MBSR Program

Mindfulness-based stress reduction, as described previously.

Intervention Type: BEHAVIORAL

HT Program

Health education curriculum, as described previously

Intervention Type: BEHAVIORAL

Other Intervention Names

Mindfulness Program; Healthy Topics Program

Eligibility Criteria

Inclusion Criteria

• 13-24 years of age
• English speaking
• Receiving care at the adolescent outpatient clinics at Johns Hopkins Children's Center (JHCC/University of Maryland Medical Center (UMMC)/Moore Clinic
• Positive for HIV and aware of his/ her status
• Prescribed anti-retroviral therapy (ART)
• Able to attend and participate in the 9 week program sessions

Exclusion Criteria

• patient currently exhibits significant psychological, developmental, or behavioral issues as assessed by the site clinical staff
• participated in a previous MBSR program or studies

• patient is transgender

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica Sibinga, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins Harriet Lane Clinic

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1R01AT007888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00093335

Identifier Type: -

Identifier Source: org_study_id