Clinical trial NCT05506644: Biofeedback for Psoriasis
Official title: A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Psoriasis Vulgaris
Psychophysiological Disorder
Anxiety
Depression
Psychological Stress
Physiological Stress
Quality of Life
Skin Disorder
Skin Diseases
Keywords: Psoriasis
Anxiety
Depression
Biofeedback
Stress
Psychophysiological Disorder
Skin Disease
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Psoriasis Area and Life Quality Index
timeFrame: 11 weeks
measure: Dermatology Life Quality Index
timeFrame: 11 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 11 weeks
measure: Patient Health Questionnaire-9
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Bastyr University Clinic
state: California
Study officials:
References: