Improving Psoriasis Through Health and Well-Being

Psoriasis Clinical Trial

Official title:

Improving Psoriasis Through Health and Well-Being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162252
• Other study ID #: 1R01AT005082
• Secondary ID: R01AT005082-01A1
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: August 12, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester; University Dermatology Associates	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-?, TNF-a, IL-17A, and the shared p40 subunit of IL-12 and IL-23 (assessed pre & post intervention).	8 weeks	No
Secondary	Immunological markers of inflammation measured from blood samples.	Circulating cytokines IL-6, TNF-a, and IL-22 measured via enzyme-linked immunoassays (ELISA) on all blood samples (pre, mid & post intervention plus follow-up).	16 weeks	No
Secondary	Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))	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).	16 weeks	No
Secondary	State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))	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).	16 weeks	No

External Links

•   Psoriasis Center (University of Rochester Medical Center)
•   The Rochester Center for Mind-Body Research (RCMBR)