PsoriasisNCT05506644
Biofeedback for Psoriasis
A study testing HRV-Biofeedback/Mind-Body Therapy in people with Psoriasis and Psoriasis Vulgaris, run by Bastyr University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Psoriasis Vulgaris, Psychophysiological Disorder
- What is being tested?
- HRV-Biofeedback/Mind-Body Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High risk of suicidality
- History of chronic kidney disease
- Pacemaker
- Active pregnancy or treatment of cancer or HIV
Trial locations and contacts
1 site in 1 country.
United States1 site
Bastyr University Clinic
San Diego, California, 92101
About this study
Official title: A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities
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.
Read the 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.
- Conditions
- Psoriasis, Psoriasis Vulgaris, Psychophysiological Disorder, Anxiety, Depression, Psychological Stress
- Being tested
- HRV-Biofeedback/Mind-Body Therapy
- Keywords
- Psoriasis, Anxiety, Depression, Biofeedback, Stress, Psychophysiological Disorder, Skin Disease
- Medical subject headings
- Psoriasis, Psychophysiologic Disorders, Anxiety Disorders, Depression, Stress, Psychological, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV-Biofeedback/Mind-Body TherapyOther
A 7-week protocol using real-time feedback on heart rate variability
| Study group | Role | What they receive |
|---|---|---|
| HRV-Biofeedback | Experimental | Not described Receives: Other: HRV-Biofeedback/Mind-Body Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Life Quality Index
Measured: 11 weeks
Dermatology Life Quality Index
Measured: 11 weeks
Generalized Anxiety Disorder-7
Measured: 11 weeks
Patient Health Questionnaire-9
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start7 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506644
- Sponsor's protocol ID
- 22-1714
- Status last verified
- Jul 2024
- First submitted
- 16 Aug 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study Exploring HRV-Biofeedback for Psoriasis and Associated Psychological Comorbidities
- ClinicalTrials.gov ID
- NCT05506644
- Acronym / sponsor ID
- 22-1714
- Conditions
- Psoriasis, Psoriasis Vulgaris, Psychophysiological Disorder, Anxiety, Depression, Psychological Stress
- Keywords
- Psoriasis, Anxiety, Depression, Biofeedback, Stress, Psychophysiological Disorder, Skin Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRV-Biofeedback | Experimental | Other: HRV-Biofeedback/Mind-Body Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- High risk of suicidality
- History of chronic kidney disease
- Pacemaker
- Active pregnancy or treatment of cancer or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV-Biofeedback/Mind-Body TherapyA 7-week protocol using real-time feedback on heart rate variability | Other | HRV-Biofeedback |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV-Biofeedback/Mind-Body Therapy in people with Psoriasis and Psoriasis Vulgaris, run by Bastyr University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Life Quality Index (time frame: 11 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.