Health Improvement for Baltimore Youth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

Conditions
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HIV, Adolescent Development, Adolescent Behavior, Medication Adherence

Intervention / Treatment
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* Behavioral: MBSR Program
* Behavioral: HT Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR Program<br>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<br>* Mindfulness-based stress reduction, as described previously.<br>* Other names: Mindfulness Program;|
| Placebo Comparator: HT Program<br>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<br>* Health education curriculum, as described previously<br>* Other names: Healthy Topics Program;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Adherence, Mental Health, Well-being, Emerging Adults, Youth