Stress, PsychologicalNCT00661271
Mindfulness-based Stress Reduction for Urban Youth
A study testing Mindfulness-based stress reduction (MBSR) and Healthy topics in people with Stress, Psychological, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program. Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Mindfulness-based stress reduction (MBSR) and Healthy topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.
Who cannot join
- Significant developmental, behavioral, substance abuse, or psychiatric disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins, Harriet Lane Clinic
Baltimore, Maryland, 21287
Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic
Philadelphia, Pennsylvania, 19104
About this study
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.
Read the detailed description
A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.
- Conditions
- Stress, Psychological
- Being tested
- Mindfulness-based stress reduction (MBSR), Healthy topics
- Keywords
- mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR)Behavioural
Also called MBSR
8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.
Healthy topicsBehavioural
8 week health education program with one retreat session
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 8-week mindfulness-based stress reduction program with one retreat session Receives: Behavioral: Mindfulness-based stress reduction (MBSR) |
| Healthy Topics | Active comparator | 8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill Receives: Behavioral: Healthy topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Attention and Awareness Scale (MAAS)
- Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness
- Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism
- Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior
Measured: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Secondary outcomes (1)
Quality of Life
Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety.
Measured: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- 96 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 M Sibinga, MD, MHS, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661271
- Sponsor's protocol ID
- NA_00002064
- Other IDs
- R21AT005209
- Status last verified
- May 2018
- First submitted
- 15 Apr 2008
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25.
PubMed 29067834Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25.
PubMed 24767265
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction for Urban Youth
- ClinicalTrials.gov ID
- NCT00661271
- Acronym / sponsor ID
- NA_00002064
- Conditions
- Stress, Psychological
- Keywords
- mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.
Detailed description
A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR)8-week mindfulness-based stress reduction program with one retreat session |
| Healthy Topics | Active comparator | Behavioral: Healthy topics8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.
Key exclusion criteria (1 listed)
- Significant developmental, behavioral, substance abuse, or psychiatric disorders
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 |
|---|---|---|
| Mindfulness-based stress reduction (MBSR)Also: MBSR8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session. | Behavioural | Mindfulness-Based Stress Reduction |
| Healthy topics8 week health education program with one retreat session | Behavioural | Healthy Topics |
Primary outcome
Mindful Attention and Awareness Scale (MAAS)
Time frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
* Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness * Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism * Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior
1 secondary outcome
Quality of Life
Time frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29067834Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25.
- Derived from this study: PubMed 24767265Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25.
- 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 M Sibinga, MD, MHS 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 Mindfulness-based stress reduction (MBSR) and Healthy topics in people with Stress, Psychological, 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 1 inclusion and 1 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 28 Jun 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. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mindful Attention and Awareness Scale (MAAS) (time frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661271, which also lists 2 linked publications.
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 28 Jun 2018.