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Biofeedback for Psoriasis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05506644
Enrollment
5
Registered
2022-08-18
Start date
2022-06-07
Completion date
2023-03-31
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Physiological Stress, Psoriasis, Psoriasis Vulgaris, Psychological Stress, Psychophysiological Disorder, Quality of Life, Skin Diseases, Skin Disorder

Keywords

Psoriasis, Anxiety, Depression, Biofeedback, Stress, Psychophysiological Disorder, Skin Disease

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.

Interventions

OTHERHRV-Biofeedback/Mind-Body Therapy

A 7-week protocol using real-time feedback on heart rate variability

Sponsors

Bastyr University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Psoriasis Area and Life Quality Index11 weeks
Dermatology Life Quality Index11 weeks
Generalized Anxiety Disorder-711 weeks
Patient Health Questionnaire-911 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026