Psoriasis Clinical Trial

Biofeedback for Psoriasis

Summary

We are conducting a proof-of-concept trial to study the impact of HRV-biofeedback, a mind-body technique designed to improve stress resilience, on the quality of life, mood, and clinical skin severity of patients with psoriasis.

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Full Description

Psoriasis is a common, chronic stress-related disease of the skin and joints that is associated with significantly impaired quality of life (QoL) and psychological comorbidity, most notably anxiety, depression, and suicidality. The objective of this study is to explore the influence of heart rate variability-biofeedback training (HRV-BF) on measures rating QoL, mental health, and clinical severity of psoriasis. We aim to further understand the bidirectional relationship between stress and the skin and to determine whether HRV-BF has the potential to be a beneficial adjuvant therapy for psychocutaneous disorders. A single-arm, proof-of-concept trial will be conducted using a modified, 7-week HRV-BF resiliency protocol at Bastyr University California in a small sample of subjects with moderate to severe plaque psoriasis. In order to measure the outcomes of the intervention on the clinical manifestations of psoriasis, we will be administering a set of validated, physician-rated and patient-reported questionnaires, including the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Patient Health Questionnaire (PHQ-9), and Generalized Anxiety Disorder (GAD-7), in addition to other HRV-BF-specific screening questionnaires to assess whether the subject has any contraindications to this protocol. These assessments will be collected at baseline, end of trial, and at 1-month follow-up for statistical analysis. The goal of this trial is to explore the novel application of HRV-BF for psychocutaneous disorders in order to fill a gap in the provision of evidence-based, integrative services addressing the serious and sometimes fatal psychological impacts of psoriasis.

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Eligibility Criteria

Inclusion Criteria:

At least 18 years old
Diagnosed with or are currently experiencing symptoms of psoriasis
Located in San Diego or within driving distance
Have daily access to a smart phone, computer, or tablet
Able to read and understand English

Exclusion Criteria:

High risk of suicidality
History of chronic kidney disease
Pacemaker
Active pregnancy or treatment of cancer or HIV

Study is for people with:

Psoriasis

Estimated Enrollment:

5

Study ID:

NCT05506644

Recruitment Status:

Recruiting

Sponsor:

Bastyr University

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There is 1 Location for this study

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Bastyr University Clinic
San Diego California, 92101, United States More Info
Sarah Park, BS
Contact
503-997-6599
[email protected]
Jae Hwa Park, BS
Sub-Investigator
Maya Roth, ND
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

5

Study ID:

NCT05506644

Recruitment Status:

Recruiting

Sponsor:


Bastyr University

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