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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271856

Enrollment

177

Registered

2006-01-04

Start date

2005-05-31

Completion date

2009-09-30

Last updated

2012-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

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

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.

Detailed description

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.

Interventions

BEHAVIORALMindfulness-Based Stress Reduction (MBSR)

8 week MBSR course

BEHAVIORALHIV-education and self-management workshop

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)	baseline to 12 months	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.
Change in CD4 T-cell Count	baseline to 12 months	—
Change in Depression as Measured by Beck Depression Inventory (BDI)	baseline to 12 months	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.
Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)	baseline to 12 months	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.
Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score	baseline to 12 months	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.
Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score	baseline to 12 months	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.

Secondary

Measure	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

Countries

United States

Participant flow

Recruitment details

Participants were recruited between July 2005 to August 2008 through newspaper advertisements, electronic bulletin boards, community postings and fliers in clinics.

Pre-assignment details

Enrolled participants were screened to determine if inclusion criteria were met. This process included structured phone interviews, medical history review, and laboratory results.

Participants by arm

Arm	Count
0 Mindfulness-Based Stress Reduction (MBSR) Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.	89
1-HIV Education/Self-management HIV education/self-management workshop: 8 weekly classes.	88
Total	177

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	10	11
Overall Study	Withdrawal by Subject	1	7

Baseline characteristics

Characteristic	1-HIV Education/Self-management	0 Mindfulness-Based Stress Reduction (MBSR)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	0 Participants	1 Participants
Age, Categorical Between 18 and 65 years	87 Participants	89 Participants	176 Participants
Age Continuous	40.5 years STANDARD_DEVIATION 9.5	41.1 years STANDARD_DEVIATION 9.36	40.8 years STANDARD_DEVIATION 9.41
Region of Enrollment United States	88 participants	89 participants	177 participants
Sex: Female, Male Female	2 Participants	4 Participants	6 Participants
Sex: Female, Male Male	86 Participants	85 Participants	171 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 89	0 / 88
serious Total, serious adverse events	0 / 89	0 / 88