Health TrialsbyHealthPanel

FlowMD Feasibility Study

ConditionAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational University of Natural Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are 18-65 years old

Have an anxiety disorder

Have a smartphone

Able to download the FlowMD app

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention

    Other intervention

    4 weeks daily usage of FlowMD guided breathwork sessions

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of the FlowMD mobile app

Outcome measured using the Feasibility Survey with a Max Score of 32 indicating strong feasibility

Time frame
From enrollment to end of intervention at 4 weeks

Secondary outcomes

1

Generalized Anxiety Disorder-7 (GAD-7) Score

Outcome measured using the Generalized Anxiety Disorder-7 (GAD-7) survey. Score scale 0-21. Lower score indicates condition improvement.

Time frame
From Enrollment to the end of the intervention at 4 weeks
2

Hamilton Anxiety Rating Scale (HAM-A) Score

Outcome measured using the Hamilton Anxiety Rating Scale (HAM-A) survey. Score scale 0-56. Lower score indicates condition improvement.

Time frame
From Enrollment to the end of the intervention at 4 weeks
3

State-Trait Anxiety Inventory (STAI)

Outcome measured using the State-Trait Anxiety Inventory (STAI) survey. Score scale 20-80. Lower score indicates condition improvement.

Time frame
From Enrollment to the end of the intervention at 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Natural Medicine

Lead sponsor

Source ClinicalTrials.gov
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