Biofeedback for Psoriasis

• Sponsor: Bastyr University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05506644
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis; Psoriasis Vulgaris; Psychophysiological Disorder; Anxiety; Depression; Psychological Stress; Physiological Stress; Quality of Life; Skin Disorder; Skin Diseases	Other: HRV-Biofeedback/Mind-Body Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities
• Actual Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HRV-Biofeedback	Other: HRV-Biofeedback/Mind-Body Therapy; A 7-week protocol using real-time feedback on heart rate variability

Outcome Measures

Primary Outcome Measures

1. Psoriasis Area and Life Quality Index [11 weeks]

2. Dermatology Life Quality Index [11 weeks]

3. Generalized Anxiety Disorder-7 [11 weeks]

4. Patient Health Questionnaire-9 [11 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bastyr University Clinic	San Diego	California	United States	92101

Sponsors and Collaborators

• Bastyr University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bastyr University
• ClinicalTrials.gov Identifier: NCT05506644
• Other Study ID Numbers: 22-1714
• First Posted: Aug 18, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bastyr University: Psoriasis; Anxiety; Depression; Biofeedback; Stress; Psychophysiological Disorder; Skin Disease
• Additional relevant MeSH terms: Psoriasis; Skin Diseases; Disease; Psychophysiologic Disorders; Depression; Stress, Psychological

Study Results

No Results Posted as of Aug 18, 2022