Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV

NCT00271856 | Completed Phase 2 Results DMC

• 1 other identifier: P01AT002024
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load, stress hormones, depression and quality of life.

Conditions

HIV

Keywords

HIV; Meditation; Stress; Randomized Controlled Trial; Complementary Therapies; MBSR; Not on ART medications

Outcome Measures

Primary Outcomes (6)

• Change in CD4 T-cell Count

  baseline to 12 months

• Change in Depression as Measured by Beck Depression Inventory (BDI)

  The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.

  baseline to 12 months

• Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)

  Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.

  baseline to 12 months

• Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score

  Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.

  baseline to 12 months

• Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score

  Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.

  baseline to 12 months

• Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)

  We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.

  baseline to 12 months

Secondary Outcomes (1)

• Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging

  3, 6, and 12 months

Study Arms (2)

0

EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR)

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

1

ACTIVE COMPARATOR

HIV education/self-management workshop

Behavioral: HIV-education and self-management workshop

Interventions

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

8 week MBSR course

Also known as: Mindfulness meditation

0

HIV-education and self-management workshop BEHAVIORAL

8-week group covering a variety of educational topics about managing HIV infection.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+
• Viral Load\>100
• CD4 T-Cells\>250
• Not on Antiretroviral therapy (ART)
• Ability to Speak English
• Stable address/living situation

You may not qualify if:

• Inability to provide informed consent
• Use of ART within the past 120 days
• Any substance abuse,mental health or medical condition that the opinion of the Principal Investigator (PI) would make it difficult for the potential participant to participate in the intervention
• Plans to start ART in the next 12 months
• Previous MBSR training and/or current practice
• Current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos.
• Initiation of new class of psychiatric medication in past 2 months.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94143-1726, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction; Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Patricia Moran, PhD
• Organization: UCSF Osher Center for Integrative Medicine

moranp@ocim.ucsf.edu

415.353.9745

Study Officials

• Frederick M. Hecht, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Susan Folkman, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 4, 2006
• Study Start: May 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 17, 2012
• Results First Posted: March 6, 2012

Record last verified: 2012-04

Locations

US (1)