Improving Psoriasis Through Health and Well-Being

University of Rochester

Status: Completed

Conditions: Psoriasis

Treatments: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Living Well

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01162252

R01AT005082-01A1 (U.S. NIH Grant/Contract)

1R01AT005082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Active Comparator group

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Living Well

Active Comparator group

Treatment:

Behavioral: Living Well