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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT007888 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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:
Investigators will also explore:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR Program | Behavioral | Mindfulness-based stress reduction, as described previously. |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for supplement study:
• patient is transgender
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| Name | Affiliation | Role |
|---|---|---|
| Erica Sibinga, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| Johns Hopkins Harriet Lane Clinic |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D055118 | Medication Adherence |
| D000074822 | Treatment Adherence and Compliance |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |
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| HT Program | Behavioral | Health education curriculum, as described previously |
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| 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 |
| 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 |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| D010549 |
| Personal Satisfaction |