HIVNCT02624193
Health Improvement for Baltimore Youth
A study testing MBSR Program and HT Program in people with HIV and Adolescent Development, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV, Adolescent Development, Adolescent Behavior
- What is being tested?
- MBSR Program and HT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to 25 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- patient currently exhibits significant psychological, developmental, or behavioral issues as assessed by the site clinical staff
- participated in a previous MBSR program or studies
- patient is transgender
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Harriet Lane Clinic
Baltimore, Maryland, 21287
About this study
Official title: 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.
Read the 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:
- (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.
- Conditions
- HIV, Adolescent Development, Adolescent Behavior, Medication Adherence
- Being tested
- MBSR Program, HT Program
- Keywords
- Treatment Adherence, Mental Health, Well-being, Emerging Adults, Youth
- Medical subject headings
- Adolescent Behavior, Medication Adherence, Treatment Adherence and Compliance, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR ProgramBehavioural
Also called Mindfulness Program
Mindfulness-based stress reduction, as described previously.
HT ProgramBehavioural
Also called Healthy Topics Program
Health education curriculum, as described previously
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MBSR Program |
| 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. Receives: Behavioral: HT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, and follow up at 3, 6, and 12 months
Secondary outcomes (18)
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.
Measured: Baseline, and follow up at 3, 6, and 12 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and follow up at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startApr 2013
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Erica Sibinga, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624193
- Sponsor's protocol ID
- NA_00093335
- Other IDs
- 1R01AT007888
- Status last verified
- Oct 2018
- First submitted
- 10 Jun 2015
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment Adherence in HIV-Positive Youth Through Mindfulness Training
- ClinicalTrials.gov ID
- NCT02624193
- Acronym / sponsor ID
- NA_00093335
- Conditions
- HIV, Adolescent Development, Adolescent Behavior, Medication Adherence
- Keywords
- Treatment Adherence, Mental Health, Well-being, Emerging Adults, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2013
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR Program | Experimental | Behavioral: MBSR ProgramMBSR 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. |
| HT Program | Placebo comparator | Behavioral: HT ProgramHealthy 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. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- patient currently exhibits significant psychological, developmental, or behavioral issues as assessed by the site clinical staff
- participated in a previous MBSR program or studies
- patient is transgender
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSR ProgramAlso: Mindfulness ProgramMindfulness-based stress reduction, as described previously. | Behavioural | MBSR Program |
| HT ProgramAlso: Healthy Topics ProgramHealth education curriculum, as described previously | Behavioural | HT Program |
Primary outcome
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.
18 secondary outcomes
NIH Emotion Measures Questionnaire
Time frame: Baseline, and follow up at 3, 6, and 12 months
Illness Cognition (IC) Scale
Time frame: Baseline, and follow up at 3, 6, and 12 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Mindful Acceptance and Awareness Scale (MAAS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Differential Emotions Scale (DES) - selected items
Time frame: Baseline, and follow up at 3, 6, and 12 months
State-Trait Anger Expressivity Inventory (STAXI)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Children's PTSD Symptom Severity Checklist (CPSS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Compassion Scale
Time frame: Baseline, and follow up at 3, 6, and 12 months
Perceived Stress Scale (PSS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Sex Risk Scale
Time frame: Baseline, and follow up at 3, 6, and 12 months
Lesbian & Gay Identity Scale (LGIS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
General Health Assessment
Time frame: Baseline, and follow up at 3, 6, and 12 months
Youth Quality of Life scale (YQOL)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Brief COPE Questionnaire
Time frame: Baseline, and follow up at 3, 6, and 12 months
Children's Response Style Questionnaire (CRSQ)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Das-Naglieri Cognitive Assessment System (CAS)
Time frame: Baseline, and follow up at 3, 6, and 12 months
Emotion Stroop Task
Time frame: Baseline, and follow up at 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Sibinga, MD principal investigator
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR Program and HT Program in people with HIV and Adolescent Development, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treatment Adherence (time frame: Baseline, and follow up at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.