Clinical trial NCT02624193: Health Improvement for Baltimore Youth
Official title: Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Adolescent Development
Adolescent Behavior
Medication Adherence
Keywords: Treatment Adherence
Mental Health
Well-being
Emerging Adults
Youth
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-12-08
Enrollment: 97
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Exclusion Criteria for supplement study:

• patient is transgender

Primary outcomes:
measure: Change in Treatment Adherence
timeFrame: Baseline, and follow up at 3, 6, and 12 months
Secondary outcomes:
measure: NIH Emotion Measures Questionnaire
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Illness Cognition (IC) Scale
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Mindful Acceptance and Awareness Scale (MAAS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Differential Emotions Scale (DES) - selected items
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: State-Trait Anger Expressivity Inventory (STAXI)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Children's PTSD Symptom Severity Checklist (CPSS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Compassion Scale
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Sex Risk Scale
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Lesbian & Gay Identity Scale (LGIS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: General Health Assessment
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Youth Quality of Life scale (YQOL)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Brief COPE Questionnaire
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Children's Response Style Questionnaire (CRSQ)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Das-Naglieri Cognitive Assessment System (CAS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Emotion Stroop Task
timeFrame: Baseline, and follow up at 3, 6, and 12 months
Other outcomes:
measure: Berkeley Expressivity Questionnaire (BEQ)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Children's Emotion Management Scales (CEMS)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Differential Emotions Scale (DES)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Emotion Approach Coping Scale (EAC)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Flanker Inhibitory Control and Attention Test Age 12+ v2.0
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: List Sorting Working Memory Test Age 7+ v2.0
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Dimensional Change Card Sort Test Age 12+ v2.0
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Picture Sequence Memory Test Age 8+ (Form A) v2.0
timeFrame: Baseline, and follow up at 3, 6, and 12 months
measure: Heart Rate Variability (HRV)
timeFrame: Baseline, and follow up at 3, 6, and 12 months
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Harriet Lane Clinic
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Erica Sibinga, MD
role: PRINCIPAL_INVESTIGATOR
References: