Improving Psoriasis Through Health and Well-Being
This study is currently recruiting participants.
Verified January 2013 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Information provided by (Responsible Party):
Jan Moynihan, University of Rochester
ClinicalTrials.gov Identifier:
NCT01162252
First received: June 21, 2010
Last updated: January 31, 2013
Last verified: January 2013
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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).
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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:
- 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162252
Contacts
| Contact: Jeffrey Swan, MA | (585) 275-6835 | jeffrey_swan@urmc.rochester.edu |
| Contact: Iwona Juskiewicz, MD | (585) 273-4700 | iwona_juskiewicz@urmc.rochester.edu |
Locations
| United States, New York | |
| University of Rochester; University Dermatology Associates | Recruiting |
| 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: | January 31, 2013 |
| 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 May 23, 2013