Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05506644 |
| Other study ID # |
22-1714 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
