An interventional study of HRV-Biofeedback/Mind-Body Therapy in Psoriasis, Psoriasis Vulgaris and Psychophysiological Disorder, sponsored by Bastyr University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Bastyr University · Not applicable, Interventional, and Supportive care
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.
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 5 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bastyr University is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: HRV-Biofeedback/Mind-Body Therapy
A 7-week protocol using real-time feedback on heart rate variability
Psoriasis Area and Life Quality Index
Time frame: 11 weeks
Dermatology Life Quality Index
Time frame: 11 weeks
Generalized Anxiety Disorder-7
Time frame: 11 weeks
Patient Health Questionnaire-9
Time frame: 11 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Dec 2022, 6 months.
Of 115 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 6 months is below that.
Counting every sponsor, half of 134 studies reached it within 19 months; a quarter within 8 and three quarters within 38.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Bastyr University