Improving Psoriasis Through Health and Well-Being

NCT ID: NCT01162252

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-12-31

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:

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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Based Stress Reduction

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Living Well

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR LW

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Jan Moynihan

Director, The Rochester Center for Mind-Body Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan A Moynihan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester; University Dermatology Associates

Rochester, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.urmc.rochester.edu/psychiatry/research/rcmbr/index.cfm

The Rochester Center for Mind-Body Research (RCMBR)

http://www.urmc.rochester.edu/dermatology/psoriasis

Psoriasis Center (University of Rochester Medical Center)

Other Identifiers

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R01AT005082-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AT005082

Identifier Type: NIH

Identifier Source: org_study_id

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