Health Improvement for Baltimore Youth

HIV Clinical Trial

Official title:

Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624193
• Other study ID #: NA_00093335
• Secondary ID: 1R01AT007888
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: June 25, 2018

Study information

• Verified date: October 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Development
• HIV
• Medication Adherence

Intervention

Behavioral:
• MBSR Program
Mindfulness-based stress reduction, as described previously.
• HT Program
Health education curriculum, as described previously

Locations

Country	Name	City	State
United States	Johns Hopkins Harriet Lane Clinic	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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