PsoriasisNCT01162252
Improving Psoriasis Through Health and Well-Being
A study testing Mindfulness-Based Stress Reduction and Living Well in people with Psoriasis, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Mindfulness-Based Stress Reduction and Living Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- English speaking
- Clinical diagnosis of psoriasis (active at initial visit)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Rochester; University Dermatology Associates
Rochester, New York, 14623
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Mindfulness-Based Stress Reduction, Living Well
- Keywords
- psoriasis, mindfulness, MBSR, stress, living well
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
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 WellBehavioural
Also called LW
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Living Well | Active comparator | Not described Receives: Behavioral: Living Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jan Moynihan, University of Rochester
- Investigators
- Jan A Moynihan, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162252
- Sponsor's protocol ID
- 1R01AT005082
- Other IDs
- R01AT005082-01A1
- Status last verified
- Aug 2014
- First submitted
- 21 Jun 2010
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Psoriasis Through Health and Well-Being
- ClinicalTrials.gov ID
- NCT01162252
- Acronym / sponsor ID
- 1R01AT005082
- Conditions
- Psoriasis
- Keywords
- psoriasis, mindfulness, MBSR, stress, living well
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Active comparator | Behavioral: Mindfulness-Based Stress Reduction |
| Living Well | Active comparator | Behavioral: Living Well |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- English speaking
- Clinical diagnosis of psoriasis (active at initial visit)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRThe 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. | Behavioural | Mindfulness-Based Stress Reduction |
| Living WellAlso: LWThe 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. | Behavioural | Living Well |
Primary outcome
Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
Time frame: 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).
3 secondary outcomes
Immunological markers of inflammation measured from blood samples.
Time frame: 16 weeks
Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))
Time frame: 16 weeks
State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- The Rochester Center for Mind-Body Research (RCMBR)Link provided by the sponsor.
- Psoriasis Center (University of Rochester Medical Center)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan A Moynihan, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Living Well in people with Psoriasis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.