Improving Psoriasis Through Health and Well-Being
- Conditions
- Psoriasis
- Interventions
- Behavioral: Mindfulness-Based Stress ReductionBehavioral: Living Well
- Registration Number
- NCT01162252
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Age 18 and older
- English speaking
- Clinical diagnosis of psoriasis (active at initial visit)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction - Living Well Living Well -
- Primary Outcome Measures
Name Time Method Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin. 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
Name Time Method Immunological markers of inflammation measured from blood samples. 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).
Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983)) 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).
State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970)) 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).
Trial Locations
- Locations (1)
University of Rochester; University Dermatology Associates
🇺🇸Rochester, New York, United States