Biofeedback for Psoriasis

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506644
• Other study ID #: 22-1714
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2022
• Source: Bastyr University
• Contact: Sarah Park, BS
• Phone: 6197368092
• Email: Jaehwa.park[@]bastyr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Disease
• Physiological Stress
• Psoriasis
• Psoriasis Vulgaris
• Psychological Stress
• Psychophysiologic Disorders
• Quality of Life
• Skin Diseases
• Skin Disorder
• Stress, Psychological

Intervention

Other:
• HRV-Biofeedback/Mind-Body Therapy
A 7-week protocol using real-time feedback on heart rate variability

Locations

Country	Name	City	State
United States	Bastyr University Clinic	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Life Quality Index		11 weeks
Primary	Dermatology Life Quality Index		11 weeks
Primary	Generalized Anxiety Disorder-7		11 weeks
Primary	Patient Health Questionnaire-9		11 weeks