HIV InfectionsPhase 2MBSRNCT00600561
Mindfulness Meditation Training in HIV
A Phase 2 study testing MBSR in people with HIV Infections, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2008
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed HIV for > 6 months
- English speaking
- 18 years old or older
- Indicate some distress (>4 on the Patient Health Questionnaire-9)
- Willing to be randomized
Who cannot join
- Any substance abuse or treatment for a psychiatric disorder in the past 30 days
- Currently diagnosed with AIDS or had CD4+ T lymphocytes <200 cells
- Hepatitis (A, B, or C)
- Indicate a regular mind-body practice (e.g., yoga, meditation) in the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, 90095
About this study
Official title: Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.
Read the detailed description
Mindfulness meditation, which is described as a process of bringing awareness to moment-to-moment experience, has been receiving substantial scientific attention as a process that can be stress and health protective (Brown, Ryan, \& Creswell, 2007). Recent reviews by Baer (2003), Bishop (2002), and Grossman et al (2004) support the effectiveness of the standardized and manualized MBSR program in reducing stress and functional disability in a variety of chronic illnesses, although no studies have tested if MBSR impacts clinical markers of HIV, although some evidence suggests that MBSR improves some markers of innate immunity and quality of life in HIV-infected adults (see Robinson, Mathews, \& Witek-Janusek, 2003). In this study, we propose to extend this work by investigating the impact of this intervention on biological and functional health status in HIV-positive adults.
We propose to determine whether the 8-week MBSR program is more effective than a one-day MBSR seminar in: (1) maintaining immune resistance in HIV infection (i.e. maintaining counts of CD4+ T lymphocytes and reducing HIV viral load), and (2) improving HIV-related quality of life. Additional analyses will test for a dose-response effect of MBSR by examining if MBSR class attendance and daily meditation practice are associated with the primary and secondary outcomes. These aims will be tested in a sample of 50 HIV-positive adults that is diverse with respect to ethnicity, gender and sexual orientation.
- Conditions
- HIV Infections
- Being tested
- MBSR
- Keywords
- meditation, mindfulness, HIV, CD4, Complementary Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Also called mindfulness meditation, attention training
Mindfulness-Based Stress Reduction Intervention
| Study group | Role | What they receive |
|---|---|---|
| 1-Day MBSR | Active comparator | One-day condensed MBSR class Receives: Behavioral: MBSR |
| 8-week MBSR | Experimental | 8-week Mindfulness-Based Stress Reduction Intervention Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ T lymphocytes (counts)
Measured: Pre-test and post-test
Secondary outcomes (2)
HIV-related Quality of Life
Measured: Pre-test and post-test
HIV viral load
Measured: Pre-test and post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Hector F Myers, PhD, Principal investigator, University of California, Los AngelesJ. David Creswell, PhD, Study director, Cousins Center for Psychoneuroimmunology, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600561
- Sponsor's protocol ID
- MBSR-HIV-Trial-Seedgrant
- Other IDs
- M01RR000865
- Acronym
- MBSR
- Status last verified
- Jan 2008
- First submitted
- 14 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hinkin CH, Barclay TR, Castellon SA, Levine AJ, Durvasula RS, Marion SD, Myers HF, Longshore D. Drug use and medication adherence among HIV-1 infected individuals. AIDS Behav. 2007 Mar;11(2):185-94. doi: 10.1007/s10461-006-9152-0.
PubMed 16897351Creswell JD, Way BM, Eisenberger NI, Lieberman MD. Neural correlates of dispositional mindfulness during affect labeling. Psychosom Med. 2007 Jul-Aug;69(6):560-5. doi: 10.1097/PSY.0b013e3180f6171f. Epub 2007 Jul 18.
PubMed 17634566Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
PubMed 18678242
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
- ClinicalTrials.gov ID
- NCT00600561
- Acronym / sponsor ID
- MBSR / MBSR-HIV-Trial-Seedgrant
- Conditions
- HIV Infections
- Keywords
- meditation, mindfulness, HIV, CD4, Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 25 Jan 2008 (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.
The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.
Detailed description
Mindfulness meditation, which is described as a process of bringing awareness to moment-to-moment experience, has been receiving substantial scientific attention as a process that can be stress and health protective (Brown, Ryan, \& Creswell, 2007). Recent reviews by Baer (2003), Bishop (2002), and Grossman et al (2004) support the effectiveness of the standardized and manualized MBSR program in reducing stress and functional disability in a variety of chronic illnesses, although no studies have tested if MBSR impacts clinical markers of HIV, although some evidence suggests that MBSR improves some markers of innate immunity and quality of life in HIV-infected adults (see Robinson, Mathews, \& Witek-Janusek, 2003). In this study, we propose to extend this work by investigating the impact of this intervention on biological and functional health status in HIV-positive adults.
We propose to determine whether the 8-week MBSR program is more effective than a one-day MBSR seminar in: (1) maintaining immune resistance in HIV infection (i.e. maintaining counts of CD4+ T lymphocytes and reducing HIV viral load), and (2) improving HIV-related quality of life. Additional analyses will test for a dose-response effect of MBSR by examining if MBSR class attendance and daily meditation practice are associated with the primary and secondary outcomes. These aims will be tested in a sample of 50 HIV-positive adults that is diverse with respect to ethnicity, gender and sexual orientation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Day MBSR | Active comparator | Behavioral: MBSROne-day condensed MBSR class |
| 8-week MBSR | Experimental | Behavioral: MBSR8-week Mindfulness-Based Stress Reduction Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed HIV for > 6 months
- English speaking
- 18 years old or older
- Indicate some distress (>4 on the Patient Health Questionnaire-9)
- Willing to be randomized
Key exclusion criteria (4 listed)
- Any substance abuse or treatment for a psychiatric disorder in the past 30 days
- Currently diagnosed with AIDS or had CD4+ T lymphocytes <200 cells
- Hepatitis (A, B, or C)
- Indicate a regular mind-body practice (e.g., yoga, meditation) in the past six months
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 |
|---|---|---|
| MBSRAlso: mindfulness meditation, attention trainingMindfulness-Based Stress Reduction Intervention | Behavioural | 1-Day MBSR, 8-week MBSR |
Primary outcome
CD4+ T lymphocytes (counts)
Time frame: Pre-test and post-test
2 secondary outcomes
HIV-related Quality of Life
Time frame: Pre-test and post-test
HIV viral load
Time frame: Pre-test and post-test
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 25 Jan 2008.
- Background: PubMed 16897351Hinkin CH, Barclay TR, Castellon SA, Levine AJ, Durvasula RS, Marion SD, Myers HF, Longshore D. Drug use and medication adherence among HIV-1 infected individuals. AIDS Behav. 2007 Mar;11(2):185-94. doi: 10.1007/s10461-006-9152-0.
- Background: PubMed 17634566Creswell JD, Way BM, Eisenberger NI, Lieberman MD. Neural correlates of dispositional mindfulness during affect labeling. Psychosom Med. 2007 Jul-Aug;69(6):560-5. doi: 10.1097/PSY.0b013e3180f6171f. Epub 2007 Jul 18.
- Derived from this study: PubMed 18678242Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
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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.
Hector F Myers, PhD principal investigator
University of California, Los Angeles
J. David Creswell, PhD study director
Cousins Center for Psychoneuroimmunology, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBSR in people with HIV Infections, run by University of California, Los Angeles at 1 site 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 5 inclusion and 4 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 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CD4+ T lymphocytes (counts) (time frame: Pre-test and post-test). 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 NCT00600561, which also lists 3 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 25 Jan 2008.