NCT07672925

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
5mo left

Started Oct 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress66%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 1, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

anxietybreathworkmeditationfeasibilitymobile app

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the FlowMD mobile app

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

    From enrollment to end of intervention at 4 weeks

Secondary Outcomes (3)

  • Generalized Anxiety Disorder-7 (GAD-7) Score

    From Enrollment to the end of the intervention at 4 weeks

  • Hamilton Anxiety Rating Scale (HAM-A) Score

    From Enrollment to the end of the intervention at 4 weeks

  • State-Trait Anxiety Inventory (STAI)

    From Enrollment to the end of the intervention at 4 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Daily guided breathwork using the FlowMD mobile app

Other: Intervention

Control

NO INTERVENTION

Control Group with no Intervention

Interventions

4 weeks daily usage of FlowMD guided breathwork sessions

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Heather Zwickey, PhD

    National University of Natural Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle T Berg, Master of Clinical Research

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 29, 2026

Study Start

October 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations