Biofeedback for Psoriasis
Primary Purpose
Psoriasis, Psoriasis Vulgaris, Psychophysiological Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HRV-Biofeedback/Mind-Body Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis focused on measuring Psoriasis, Anxiety, Depression, Biofeedback, Stress, Psychophysiological Disorder, Skin Disease
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
Sites / Locations
- Bastyr University ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HRV-Biofeedback
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis Area and Life Quality Index
Dermatology Life Quality Index
Generalized Anxiety Disorder-7
Patient Health Questionnaire-9
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05506644
Brief Title
Biofeedback for Psoriasis
Official Title
A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bastyr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HRV-Biofeedback
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
HRV-Biofeedback/Mind-Body Therapy
Intervention Description
A 7-week protocol using real-time feedback on heart rate variability
Primary Outcome Measure Information:
Title
Psoriasis Area and Life Quality Index
Time Frame
11 weeks
Title
Dermatology Life Quality Index
Time Frame
11 weeks
Title
Generalized Anxiety Disorder-7
Time Frame
11 weeks
Title
Patient Health Questionnaire-9
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Park, BS
Phone
6197368092
Email
Jaehwa.park@bastyr.edu
Facility Information:
Facility Name
Bastyr University Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Park, BS
Phone
503-997-6599
Email
Jaehwa.park@bastyr.edu
First Name & Middle Initial & Last Name & Degree
Jae Hwa Park, BS
First Name & Middle Initial & Last Name & Degree
Maya Roth, ND
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biofeedback for Psoriasis
We'll reach out to this number within 24 hrs