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Recruiting NCT07672925

FlowMD Feasibility Study

No phase Interventional Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention.
Who it may be relevant to
Registry conditions: Anxiety. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility of Using a Meditation App in Adults With Anxiety Disorder

Overview

The goal of this clinical trial is to learn if the FlowMD mobile app is feasible to be used to manage mild anxiety in adults. It will also learn if the app is effective at managing anxiety in adults. Participants will: Use the FlowMD app daily to complete a 1-5 minute guided breathwork session over the course of 4 weeks. Complete surveys at the beginning, midpoint, and end of the study to measure anxiety levels and usability of the app.

Interventions

  • Other Intervention
    4 weeks daily usage of FlowMD guided breathwork sessions

Primary outcome measures

  • Feasibility of the FlowMD mobile app [Time frame: From enrollment to end of intervention at 4 weeks]
Secondary outcome measures (3)
  • Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: From Enrollment to the end of the intervention at 4 weeks]
  • Hamilton Anxiety Rating Scale (HAM-A) Score [Time frame: From Enrollment to the end of the intervention at 4 weeks]
  • State-Trait Anxiety Inventory (STAI) [Time frame: From Enrollment to the end of the intervention at 4 weeks]

Eligibility criteria

Inclusion criteria

  • Are 18-65 years old
  • Have an anxiety disorder
  • Have a smartphone
  • Able to download the FlowMD app
  • Willing to use the FlowMD meditation app for a daily 1-5 minute session for four consecutive weeks
  • Able to provide feedback on the experience using the app
  • Willing to participate in surveys to measure changes in anxiety levels

Exclusion criteria

  • Are undergoing significant changes in psychiatric medication or therapy
  • Have severe psychiatric conditions that might interfere with study participation (Schizophrenia, Bipolar Disorder, Major Depressive Disorder)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Helfgott Research Institute — Portland

Identifiers

NCT: NCT07672925 · HZ71724

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗