Improving Psoriasis Through Health and Well-Being
2 other identifiers
interventional
130
1 country
1
Brief Summary
The purpose of the study is to examine and compare the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 13, 2014
August 1, 2014
3.8 years
June 21, 2010
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
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).
8 weeks
Secondary Outcomes (3)
Immunological markers of inflammation measured from blood samples.
16 weeks
Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))
16 weeks
State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))
16 weeks
Study Arms (2)
Mindfulness-Based Stress Reduction
ACTIVE COMPARATORLiving Well
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18 and older
- English speaking
- Clinical diagnosis of psoriasis (active at initial visit)
You may not qualify if:
- currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or \< 6 months post-chemo or radiation)
- major, uncorrected sensory impairments
- cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
- severe cardiovascular disease
- current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester; University Dermatology Associates
Rochester, New York, 14623, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan A Moynihan, PhD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, The Rochester Center for Mind-Body Research
Study Record Dates
First Submitted
June 21, 2010
First Posted
July 14, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 13, 2014
Record last verified: 2014-08