Health Improvement for Baltimore Youth

NCT02624193 | Completed DMC

• 2 other identifiers: NA_000933351R01AT007888
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Adolescent Development; Adolescent Behavior; Medication Adherence

Keywords

Treatment Adherence; Mental Health; Well-being; Emerging Adults; Youth

Outcome Measures

Primary Outcomes (1)

• Change in Treatment Adherence

  Assessment of impact of MBSR versus HT on treatment adherence as measured by the Adolescent Medicine Trials Network (ATN) HIV Medication Adherence self-report measure, as well as CD4 and viral load counts pulled from the participant's medical record. The measure and medical record data collection takes place at baseline, post-program (3-month follow-up), 6-month follow-up, and 12-month follow-up.

  Baseline, and follow up at 3, 6, and 12 months

Secondary Outcomes (18)

• NIH Emotion Measures Questionnaire

  Baseline, and follow up at 3, 6, and 12 months

• Illness Cognition (IC) Scale

  Baseline, and follow up at 3, 6, and 12 months

• Difficulties in Emotion Regulation Scale (DERS)

  Baseline, and follow up at 3, 6, and 12 months

• Mindful Acceptance and Awareness Scale (MAAS)

  Baseline, and follow up at 3, 6, and 12 months

• Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline, and follow up at 3, 6, and 12 months

Other Outcomes (10)

• Berkeley Expressivity Questionnaire (BEQ)

  Baseline, and follow up at 3, 6, and 12 months

• Children's Emotion Management Scales (CEMS)

  Baseline, and follow up at 3, 6, and 12 months

• Differential Emotions Scale (DES)

  Baseline, and follow up at 3, 6, and 12 months

Study Arms (2)

MBSR Program

EXPERIMENTAL

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.

Behavioral: MBSR Program

HT Program

PLACEBO COMPARATOR

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.

Behavioral: HT Program

Interventions

MBSR Program BEHAVIORAL

Mindfulness-based stress reduction, as described previously.

Also known as: Mindfulness Program

MBSR Program

HT Program BEHAVIORAL

Health education curriculum, as described previously

Also known as: Healthy Topics Program

HT Program

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Medication Adherence; Treatment Adherence and Compliance; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Personal Satisfaction

Study Officials

• Erica Sibinga, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: December 8, 2015
• Study Start: April 1, 2013
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)