Biofeedback for Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities

Conditions
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Psoriasis, Psoriasis Vulgaris, Psychophysiological Disorder, Anxiety, Depression, Psychological Stress, Physiological Stress, Quality of Life, Skin Disorder, Skin Diseases

Intervention / Treatment
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* Other: HRV-Biofeedback/Mind-Body Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRV-Biofeedback<br> | Other: HRV-Biofeedback/Mind-Body Therapy<br>* A 7-week protocol using real-time feedback on heart rate variability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Life Quality Index |  | 11 weeks | 
| Dermatology Life Quality Index |  | 11 weeks | 
| Generalized Anxiety Disorder-7 |  | 11 weeks | 
| Patient Health Questionnaire-9 |  | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Anxiety, Depression, Biofeedback, Stress, Psychophysiological Disorder, Skin Disease