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

Study Overview
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Brief Summary
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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.

Detailed Description
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Stress and depression are associated with more rapid loss of CD4 cells in HIV infection. Interventions that slow the advance of HIV infection and delay the introduction of antiretroviral therapy (ART) could make an important contribution to HIV management in both the developed and developing world. We are conducting a 330 person randomized, controlled clinical trial of MBSR for persons with HIV-1 infection and CD4 T-lymphocyte counts > 250 cells/µm who are not on antiretroviral therapy. Participants are randomized in a 1:1 distribution to either the MBSR intervention or to an education group that will control for the attention and social interaction aspects of MBSR. Participants are evaluated at 0, 3, 6 and 12 months. Key outcome measures at 12 months include differences in CD4 T cell counts, HIV viral load, perceived stress, depression, and positive affect. We are also examining whether MBSR is associated with changes in neuroendocrine function (autonomic nervous system activity, cortisol secretion) and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of MBSR and CD4 T cell counts, such as changes in T cell activation. A subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge.

Official Title
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Mindfulness-Based Stress Reduction (MBSR), Stress Arousal and Immune Response in Early HIV

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction (MBSR)
* Behavioral: HIV-education and self-management workshop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV+ Viral Load>100 CD4 T-Cells>250 Not on Antiretroviral therapy (ART) Ability to Speak English Stable address/living situation Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0<br>Mindfulness Based Stress Reduction (MBSR) | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* 8 week MBSR course<br>* Other names: Mindfulness meditation;|
| Active Comparator: 1<br>HIV education/self-management workshop | Behavioral: HIV-education and self-management workshop<br>* 8-week group covering a variety of educational topics about managing HIV infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Meditation, Stress, Randomized Controlled Trial, Complementary Therapies, MBSR, Not on ART medications