NCT05506644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

August 16, 2022

Last Update Submit

July 8, 2024

Conditions

PsoriasisPsoriasis VulgarisPsychophysiological DisorderAnxietyDepressionPsychological StressPhysiological StressQuality of LifeSkin DisorderSkin Diseases

Keywords

PsoriasisAnxietyDepressionBiofeedbackStressPsychophysiological DisorderSkin Disease

Outcome Measures

Primary Outcomes (4)

  • Psoriasis Area and Life Quality Index

    11 weeks

  • Dermatology Life Quality Index

    11 weeks

  • Generalized Anxiety Disorder-7

    11 weeks

  • Patient Health Questionnaire-9

    11 weeks

Study Arms (1)

HRV-Biofeedback

EXPERIMENTAL
Other: HRV-Biofeedback/Mind-Body Therapy

Interventions

HRV-Biofeedback/Mind-Body TherapyOTHER

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

HRV-Biofeedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • High risk of suicidality
  • History of chronic kidney disease
  • Pacemaker
  • Active pregnancy or treatment of cancer or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr University Clinic

San Diego, California, 92101, United States

Location

MeSH Terms

Conditions

PsoriasisPsychophysiologic DisordersAnxiety DisordersDepressionStress, PsychologicalSkin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

June 7, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)