Improving Psoriasis Through Health and Well-Being
|ClinicalTrials.gov Identifier: NCT01162252|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Behavioral: Mindfulness-Based Stress Reduction Behavioral: Living Well||Not Applicable|
The study examines the effects of two eight-week programs (MBSR vs. LW) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. The research will focus both on clinical measures of the disease state and overall well-being.
The Aims of our proposed intervention study are the following:
- To examine the effects of MBSR, versus the Living Well (LW) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression.
- To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
- To examine the effects of behavioral and psychological mediators on immune outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Psoriasis Through Health and Well-Being|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: Mindfulness-Based Stress Reduction||
Behavioral: Mindfulness-Based Stress Reduction
The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing.
Other Name: MBSR
|Active Comparator: Living Well||
Behavioral: Living Well
The Living Well (LW) program involves a series of informational presentations and group discussions on a variety of topics related to the promotion of health and well-being. The 8-week program is designed to provide participants with knowledge about ways to improve their physical and emotional health as a complement to traditional medical treatments.
Other Name: LW
- Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin. [ Time Frame: 8 weeks ]Psoriasis is assessed for keratinocyte proliferation including immunohistochemistry (for CD3, neutrophil elastase, keratin 6 and S100A7 markers) and quantitative real time polymerase chain reaction (qRT-PCR) to examine expression of mRNA for IFN-γ, TNF-α, IL-17A, and the shared p40 subunit of IL-12 and IL-23 (assessed pre & post intervention).
- Immunological markers of inflammation measured from blood samples. [ Time Frame: 16 weeks ]Circulating cytokines IL-6, TNF-α, and IL-22 measured via enzyme-linked immunoassays (ELISA) on all blood samples (pre, mid & post intervention plus follow-up).
- Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983)) [ Time Frame: 16 weeks ]The 14-item Perceived Stress Scale (PSS) is used to measure the degree to which current life situations are appraised as stressful by a participant (assessed at pre, mid & post intervention plus follow-up).
- State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970)) [ Time Frame: 16 weeks ]The State-Trait Anxiety Inventory (STAI) consists of two, 20-item scales to distinguish between relatively recent, transitory "state anxieties", from more chronic or persistent "trait anxiety" (assessed pre, mid & post intervention plus follow-up).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162252
|United States, New York|
|University of Rochester; University Dermatology Associates|
|Rochester, New York, United States, 14623|
|Principal Investigator:||Jan A Moynihan, PhD||University of Rochester|