Improving Psoriasis Through Health and Well-Being

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Psoriasis Through Health and Well-Being

Conditions
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Psoriasis

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Living Well


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness-Based Stress Reduction<br> | Behavioral: Mindfulness-Based Stress Reduction<br>* 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.<br>* Other names: MBSR;|
| Active Comparator: Living Well<br> | Behavioral: Living Well<br>* 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.<br>* Other names: LW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological markers of inflammation measured from blood samples. | 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). | 16 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, mindfulness, MBSR, stress, living well