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Mindfulness machine: new device may ease anxiety without pills

NCT ID NCT07628153

Symptom relief Sponsor: I.M. Sechenov First Moscow State Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called Reacor that uses biofeedback to teach mindfulness by showing your heart rate and brain waves in real time. 188 adults with anxiety disorders were split into three groups: biofeedback alone, the medication escitalopram alone, or both together. The goal was to see if the device could reduce anxiety and improve mindfulness skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Escitalopram
What this could lead to
If it works, this could offer a non-drug option for managing anxiety by training the brain to self-regulate.
What could go wrong
This is a small, completed Phase 4 trial with only 188 participants, so results may not apply to everyone. The biofeedback device is not widely available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

188 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: First time diagnosis of anxiety disorder (ICD 10 codes F40 or F41), Inpatient at the time of enrollment, Mild to moderate functional impairment according to the International Classification of Functioning, Disability and Health (ICF), Age 19-74 years, Willing and able to provide written informed consent Non-inclusion criteria: Photosensitive epilepsy, Severe intellectual, attentional, or memory impairment, Exacerbation of mental illness, Lack of motivation, Unwillingness or inability to provide written consent Exclusion Criteria: exacerbation of a severe mental and/or somatic disease, withdrawal of consent, inability to attend one or more individual sessions, refusal to do homework, inability to complete all three assessments

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Conditions

The condition(s) this trial relates to.

anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety disorders

Contacts and locations

Locations

  • Department of Psychotherapy of the A.Ya. Kozhevnikov Clinic of Nervous Diseases at the Sechenov University Clinical Center

    Moscow, 119991, Russia

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