Improving Psoriasis Through Health and Well-Being

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jan Moynihan, University of Rochester
ClinicalTrials.gov Identifier:
NCT01162252
First received: June 21, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention
Psoriasis
Behavioral: Mindfulness-Based Stress Reduction
Behavioral: Living Well

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Psoriasis Through Health and Well-Being

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Immunological markers of inflammation measured from blood samples. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 130
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162252

Locations
United States, New York
University of Rochester; University Dermatology Associates
Rochester, New York, United States, 14623
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jan A Moynihan, PhD University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Jan Moynihan, Director, The Rochester Center for Mind-Body Research, University of Rochester
ClinicalTrials.gov Identifier: NCT01162252     History of Changes
Other Study ID Numbers: 1R01AT005082, R01AT005082-01A1
Study First Received: June 21, 2010
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
psoriasis
mindfulness
MBSR
stress
living well

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014