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Behavioral Intervention

Mindfulness Meditation for Psychological Distress

Phase 1

Recruiting

Led By David Creswell, PhD

Research Sponsored by Equa Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-30 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment session at up to week 4

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to create a new feature on a meditation app called Equa to help young adults better understand their body's responses and mindfulness progress during meditation. The study will involve participants using the app to

Who is the study for?

This trial is for young adults experiencing stress and who want to improve their mindfulness skills using a meditation app. Participants must be willing to have their breathing patterns analyzed during guided meditations and complete surveys about their thoughts and feelings.

What is being tested?

The study is testing a new feature on the Equa meditation app that provides feedback based on respiration signals during meditation. It aims to help users understand physiological changes and track improvements in mindfulness through guided lessons.

What are the potential side effects?

Since this intervention involves mindfulness meditation, side effects are minimal but may include temporary discomfort or increased awareness of distressing thoughts or emotions as participants become more mindful of their internal experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ same day, change from pre-mindfulness meditation training to post-mindfulness meditation training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~same day, change from pre-mindfulness meditation training to post-mindfulness meditation training

This trial's timeline: 3 weeks for screening, Varies for treatment, and same day, change from pre-mindfulness meditation training to post-mindfulness meditation training for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Optimization of deep learning algorithms that correlate changes in respiration dynamics during meditation training to changes in mindfulness skills from pre-training to post-training

Secondary study objectives

Change from Baseline in mean state mindfulness as assessed by the Mindful Attention Awareness Scale - state at post treatment

Change from Baseline in total affect as assessed by the Positive and Negative Affect Scale at post treatment

Change from Baseline in total anxiety as assessed by the General Anxiety Disorder, 7-item questionnaire at post treatment

+6 more

Side effects data

From 2016 Phase 2 trial • 413 Patients • NCT01654289

Musculoskeletal

Cardiac Disorders

General

100%

80%

60%

40%

20%

Study treatment Arm

Exercise

Wait-list Control

Mindfulness Meditation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Respiration Biosignal Feedback ConditionExperimental Treatment1 Intervention

Participants will complete guided seated Equa training lessons on a laboratory smartphone device while physiological measures are tracked. After training lessons, a respiration biosignal feedback chart will appear.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Meditation

2015

Completed Phase 2

~4040

0 / 1Eligibility criteria met