Trial Information

Effects of Mindfulness-Based Stress Reduction (MBSR) on Immune Response to HPV

OBJECTIVES:

- To evaluate the effects of a standardized mindfulness-based stress reduction (MBSR)
intervention versus an attention control condition on psychosocial well-being (e.g.,
perceived stress and quality of life) at post-intervention and subsequent follow-up
time points.

- To evaluate the effects of an MBSR intervention versus an attention control condition
on specific immune response to HPV (i.e., T-cell proliferative response to HPV16 and
intracellular cytokine expression of HPV-stimulated T-cells) at post-intervention and
follow-up time points.

- To examine the extent to which changes in psychosocial well-being mediate the effects
of the intervention on HPV-specific immune response.

- To explore potential mechanisms of action (e.g., self-regulation, expectancies) that
are proposed to be responsible for producing intervention effects on psychosocial
well-being.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo a mindfulness-based stress reduction intervention (including
meditation techniques, body scan, awareness of breathing, mindful yoga, eating
meditation, and walking meditation) for 2 hours, once weekly for 8 weeks.

- Arm II: Patients undergo general health education on healthy lifestyles for 2 hours,
once weekly for 8 weeks.

In both arms, questionnaire packets measuring psychosocial measures, demographics, and
behavioral risk factors are administered to patients at baseline, within 2 weeks of
completing the 8-week programs, and then at 6 and 12 months. Treatment continues in the
absence of developing cervical cancer.

Blood is collected for immunologic assays. HPV status and subtype is evaluated in cervical
specimens using standard and real-time PCR techniques. Quality of Life is evaluated at
baseline, post-intervention, and at 6 and 12 months.