Biofeedback for Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis; Psoriasis Vulgaris; Psychophysiological Disorder; Depression; Psychological Stress; Quality of Life; Anxiety; Skin Disorder; Physiological Stress; Skin Diseases
• Interventions: Other: HRV-Biofeedback/Mind-Body Therapy

• Registration Number: NCT05506644
• Lead Sponsor: Bastyr University

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.

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRV-Biofeedback	HRV-Biofeedback/Mind-Body Therapy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bastyr University Clinic; 🇺🇸 San Diego, California, United States