Working… Menu

Improving Psoriasis Through Health and Well-Being

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01162252
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : August 13, 2014
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jan Moynihan, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Psoriasis Behavioral: Mindfulness-Based Stress Reduction Behavioral: Living Well Not Applicable

Detailed Description:

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:

  1. 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.
  2. To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
  3. To examine the effects of behavioral and psychological mediators on immune outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 and older
  • English speaking
  • Clinical diagnosis of psoriasis (active at initial visit)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01162252

Layout table for location information
United States, New York
University of Rochester; University Dermatology Associates
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
National Center for Complementary and Integrative Health (NCCIH)
Layout table for investigator information
Principal Investigator: Jan A Moynihan, PhD University of Rochester
Additional Information:
Layout table for additonal information
Responsible Party: Jan Moynihan, Director, The Rochester Center for Mind-Body Research, University of Rochester Identifier: NCT01162252    
Other Study ID Numbers: 1R01AT005082 ( U.S. NIH Grant/Contract )
R01AT005082-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Jan Moynihan, University of Rochester:
living well
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases