Health Improvement for Baltimore Youth

Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

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.

Study Overview

• Status: Completed
• Conditions: HIV; Medication Adherence; Adolescent Behavior; Adolescent Development
• Intervention / Treatment: Behavioral: MBSR Program; Behavioral: HT Program

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Harriet Lane Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria for supplement study:

• patient is transgender

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: MBSR Program; Mindfulness-based stress reduction, as described previously.; Other Names: Mindfulness Program
Placebo Comparator: 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.	Behavioral: HT Program; Health education curriculum, as described previously; Other Names: Healthy Topics Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Emotion Measures Questionnaire	Assessment of impact of MBSR versus HT on emotion regulation measured at baseline, post-program (3-month follow-up), 6-month follow-up, and 12-month follow-up. Specific NIH emotion measures are: meaning & purpose, positive affect, anger, fear, perceived hostility, sadness.	Baseline, and follow up at 3, 6, and 12 months
Illness Cognition (IC) Scale	Assessment of impact of MBSR versus HT on thoughts of illness measured 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
Difficulties in Emotion Regulation Scale (DERS)	Assessment of impact of MBSR versus HT on issues in emotion regulation measured 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
Mindful Acceptance and Awareness Scale (MAAS)	Assessment of impact of MBSR versus HT on mindfulness measured 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
Five Facet Mindfulness Questionnaire (FFMQ)	Assessment of impact of MBSR versus HT on multiple aspects of mindfulness measured 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
Differential Emotions Scale (DES) - selected items	Assessment of impact of MBSR versus HT on frequency of emotions (specifically, self-hostility, shame, shyness, and guilt) measured 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
State-Trait Anger Expressivity Inventory (STAXI)	Assessment of impact of MBSR versus HT on anger expression measured 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
Children's PTSD Symptom Severity Checklist (CPSS)	Assessment of impact of MBSR versus HT on trauma symptoms measured 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
Compassion Scale	Assessment of impact of MBSR versus HT on self-compassion measured 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
Perceived Stress Scale (PSS)	Assessment of impact of MBSR versus HT on perceived stress measured 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
Sex Risk Scale	Assessment of impact of MBSR versus HT on risky sexual behavior measured 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
Lesbian & Gay Identity Scale (LGIS)	Assessment of impact of MBSR versus HT on self-acceptance of lesbian/gay/bisexual identity measured 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
General Health Assessment	Assessment of impact of MBSR versus HT on general health measured 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
Youth Quality of Life scale (YQOL)	Assessment of impact of MBSR versus HT on quality of life measured 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
Brief COPE Questionnaire	Assessment of impact of MBSR versus HT on coping measured 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
Children's Response Style Questionnaire (CRSQ)	Assessment of impact of MBSR versus HT on coping responses measured 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
Das-Naglieri Cognitive Assessment System (CAS)	Assessment of impact of MBSR versus HT on cognitive functioning measured 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
Emotion Stroop Task	Assessment of impact of MBSR versus HT on emotion-based cognitive functioning measured 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berkeley Expressivity Questionnaire (BEQ)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on emotion expressivity (by gender) measured 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
Children's Emotion Management Scales (CEMS)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on management of anger, sadness, happiness, pride, and worry (by gender) measured 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
Differential Emotions Scale (DES)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on the frequency of emotions, specifically disgust, joy, sadness, surprise, contempt, interest, fear, and anger, (by gender) measured 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
Emotion Regulation Questionnaire (ERQ)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on emotion regulation (by gender) measured 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
Emotion Approach Coping Scale (EAC)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on emotion approach coping (by gender) measured 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
Flanker Inhibitory Control and Attention Test Age 12+ v2.0	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on stress response, and inhibitory control and attention (by gender) measured 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
List Sorting Working Memory Test Age 7+ v2.0	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on stress response, and working memory (by gender) measured 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
Dimensional Change Card Sort Test Age 12+ v2.0	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on stress response, and cognitive flexibility, measured 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
Picture Sequence Memory Test Age 8+ (Form A) v2.0	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on stress response, and episodic memory measured 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
Heart Rate Variability (HRV)	For those selected to be in the supplement study, assessment of impact of MBSR versus HT on stress response measured 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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Erica Sibinga, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Mental Health; Well-being; Treatment Adherence; Youth; Emerging Adults
• Other Study ID Numbers: NA_00093335; 1R01AT007888 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No