Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 97
- Locations
- 4
- Primary Endpoint
- Change in Treatment Adherence
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: MBSR Program (Behavioral)
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.
Intervention: HT Program (Behavioral)
Outcomes
Primary Outcomes
Change in Treatment Adherence
Time Frame: Baseline, and follow up at 3, 6, and 12 months
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.
Secondary Outcomes
- 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)
- State-Trait Anger Expressivity Inventory (STAXI)(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)
- 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)
- Differential Emotions Scale (DES) - selected items(Baseline, and follow up at 3, 6, and 12 months)
- Children's PTSD Symptom Severity Checklist (CPSS)(Baseline, and follow up at 3, 6, and 12 months)
- Compassion Scale(Baseline, and follow up at 3, 6, and 12 months)
- Perceived Stress Scale (PSS)(Baseline, and follow up at 3, 6, and 12 months)
- Sex Risk Scale(Baseline, and follow up at 3, 6, and 12 months)
- Lesbian & Gay Identity Scale (LGIS)(Baseline, and follow up at 3, 6, and 12 months)
- General Health Assessment(Baseline, and follow up at 3, 6, and 12 months)
- Youth Quality of Life scale (YQOL)(Baseline, and follow up at 3, 6, and 12 months)
- Brief COPE Questionnaire(Baseline, and follow up at 3, 6, and 12 months)
- Emotion Stroop Task(Baseline, and follow up at 3, 6, and 12 months)
- Children's Response Style Questionnaire (CRSQ)(Baseline, and follow up at 3, 6, and 12 months)
- Das-Naglieri Cognitive Assessment System (CAS)(Baseline, and follow up at 3, 6, and 12 months)