Mindfulness Meditation Training in HIV | NCT00600561

Studies
Mindfulness Meditation Training in HIV

NCT00600561

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Jan 25, 2008Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

HIV Infections

Interventions

MBSR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M01RR000865	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 14, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2008

Last Update Posted Date

Jan 25, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1-Day MBSR	Active Comparator	One-day condensed MBSR class	Behavioral: MBSR
8-week MBSR	Experimental	8-week Mindfulness-Based Stress Reduction Intervention	Behavioral: MBSR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MBSR	Behavioral	Mindfulness-Based Stress Reduction Intervention	1-Day MBSR 8-week MBSR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CD4+ T lymphocytes (counts)		Pre-test and post-test

Secondary Outcomes

Measure	Description	Time Frame
HIV-related Quality of Life		Pre-test and post-test
HIV viral load		Pre-test and post-test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hector F Myers, PhD	University of California, Los Angeles	Principal Investigator
J. David Creswell, PhD	Cousins Center for Psychoneuroimmunology, UCLA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cousins Center for Psychoneuroimmunology, UCLA		Los Angeles	California	90095	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16897351	Background	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.
17634566	Background	Creswell 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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities