Skip to main content
OpenTrials
Completed

NCT Number: NCT02624193

Health Improvement for Baltimore Youth

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Adolescent Behavior Adolescent Development Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Psychological Well-Being Treatment Adherence and Compliance

Age range

13 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Harriet Lane Clinic, Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR Program

Behavioral

Mindfulness-based stress reduction, as described previously.

Other names: Mindfulness Program

HT Program

Behavioral

Health education curriculum, as described previously

Other names: Healthy Topics Program

Primary outcomes

  1. 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

  1. NIH Emotion Measures Questionnaire

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  2. Illness Cognition (IC) Scale

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  3. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  4. Mindful Acceptance and Awareness Scale (MAAS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  5. Five Facet Mindfulness Questionnaire (FFMQ)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  6. Differential Emotions Scale (DES) - selected items

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  7. State-Trait Anger Expressivity Inventory (STAXI)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  8. Children's PTSD Symptom Severity Checklist (CPSS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  9. Compassion Scale

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  10. Perceived Stress Scale (PSS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  11. Sex Risk Scale

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  12. Lesbian & Gay Identity Scale (LGIS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  13. General Health Assessment

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  14. Youth Quality of Life scale (YQOL)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  15. Brief COPE Questionnaire

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  16. Children's Response Style Questionnaire (CRSQ)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  17. Das-Naglieri Cognitive Assessment System (CAS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  18. Emotion Stroop Task

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

Other outcomes

  1. Berkeley Expressivity Questionnaire (BEQ)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  2. Children's Emotion Management Scales (CEMS)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  3. Differential Emotions Scale (DES)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  4. Emotion Regulation Questionnaire (ERQ)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  5. Emotion Approach Coping Scale (EAC)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  6. Flanker Inhibitory Control and Attention Test Age 12+ v2.0

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  7. List Sorting Working Memory Test Age 7+ v2.0

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  8. Dimensional Change Card Sort Test Age 12+ v2.0

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  9. Picture Sequence Memory Test Age 8+ (Form A) v2.0

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

  10. Heart Rate Variability (HRV)

    Time frame: Baseline, and follow up at 3, 6, and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2015
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.