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Improving Psoriasis Through Health and Well-Being

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Living Well
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, mindfulness, MBSR, stress, living well

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Rochester; University Dermatology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Living Well

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
June 21, 2010
Last Updated
August 12, 2014
Sponsor
University of Rochester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01162252
Brief Title
Improving Psoriasis Through Health and Well-Being
Official Title
Improving Psoriasis Through Health and Well-Being
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, mindfulness, MBSR, stress, living well

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Active Comparator
Arm Title
Living Well
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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
Intervention Name(s)
Living Well
Other Intervention Name(s)
LW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Immunological markers of inflammation measured from blood samples.
Description
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).
Time Frame
16 weeks
Title
Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))
Description
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).
Time Frame
16 weeks
Title
State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))
Description
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).
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Moynihan, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester; University Dermatology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.urmc.rochester.edu/psychiatry/research/rcmbr/index.cfm
Description
The Rochester Center for Mind-Body Research (RCMBR)
URL
http://www.urmc.rochester.edu/dermatology/psoriasis
Description
Psoriasis Center (University of Rochester Medical Center)

Learn more about this trial

Improving Psoriasis Through Health and Well-Being

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