Health Improvement for Baltimore Youth
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, Psychiatric |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 13 - 24 |
Updated: | 11/2/2018 |
Start Date: | April 2013 |
End Date: | June 25, 2018 |
Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training
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.
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:
- (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.
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.
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
We found this trial at
2
sites
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
Click here to add this to my saved trials
Click here to add this to my saved trials