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| ID | Type | Description | Link |
|---|---|---|---|
| P01AT002024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 | Experimental | Mindfulness Based Stress Reduction (MBSR) |
|
| 1 | Active Comparator | HIV education/self-management workshop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Behavioral | 8 week MBSR course |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick M. Hecht, M.D. | University of California, San Francisco | Principal Investigator |
| Susan Folkman, PhD | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osher Center for Integrative Medicine | San Francisco | California | 94143-1726 | United States |
Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.
Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0 Mindfulness-Based Stress Reduction (MBSR) | Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. |
| FG001 | 1-HIV Education/Self-management | HIV education/self-management workshop: 8 weekly classes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0 Mindfulness-Based Stress Reduction (MBSR) | Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. |
| BG001 | 1-HIV Education/Self-management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Not Posted | 3, 6, and 12 months | |||||||||||||
| Primary | Change in CD4 T-cell Count | Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months. | Posted | Mean | 95% Confidence Interval | cells/µl | baseline to 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0 Mindfulness-Based Stress Reduction (MBSR) | Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Moran, PhD | UCSF Osher Center for Integrative Medicine | 415.353.9745 | moranp@ocim.ucsf.edu |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| HIV-education and self-management workshop | Behavioral | 8-week group covering a variety of educational topics about managing HIV infection. |
|
| 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 |
HIV education/self-management workshop: 8 weekly classes.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | 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. | ITT analyses. | Posted | Mean | 95% Confidence Interval | scores on the scale | baseline to 12 months |
|
|
|
| Primary | 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. | ITT analyses. | Posted | Mean | 95% Confidence Interval | scores on the scale | baseline to 12 months |
|
|
|
| Primary | 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. | ITT analyses | Posted | Mean | 95% Confidence Interval | scores on the scale | baseline to 12 months |
|
|
|
| Primary | 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. | ITT analyses. | Posted | Mean | 95% Confidence Interval | scores on the scale | baseline to 12 months |
|
|
|
| Primary | 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. | ITT analyses. | Posted | Mean | 95% Confidence Interval | scores on the scale | baseline to 12 months |
|
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| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | 1-HIV Education/Self-management | HIV education/self-management workshop: 8 weekly classes. | 0 | 88 | 0 | 88 |
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