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Psychological DistressNCT07639697

STEPS - Stress Training and Engagement Via Phone-Based Systems

A study testing Equa, Feature-Enhanced Equa Training Program and Stress Management Training in people with Psychological Distress and Mindfulness Skills, run by Equa Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application. Read more about this study

Who is it for?
Ages 18 to 30 years
What is being tested?
Equa, Feature-Enhanced Equa Training Program and Stress Management Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
17 Jun 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ages 18-30 years of Age
  • Fluent in English
  • Psychological distress
  • Interested in completing smartphone guided training sessions remotely for 14 days
  • Willing and able to wear physiological monitoring equipment
  • Willing to be randomized to one of three conditions
  • Located in the United States
  • Access to a smartphone without snapdragon processors to complete guided training sessions

Who cannot join

  • Currently pregnant
  • Current or previous diagnosis with psychosis or schizophrenia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juliette A Bonchonsky, BA contact

4125333601

juliette@equahealth.io

David Creswell, Ph.D. contact

4125353338

david@equahealth.io

United States1 site, 1 recruiting
  • 4615 Forbes Ave

    Pittsburgh, Pennsylvania, 15213

    Juliette Bonchonsky, B.A., 4125333601, juliette@equahealth.io

    David Creswell, PhD, 4125353338, david@equahealth.io

    Recruiting

Other trials in United States

About this study

Official title: Mindfulness Training and Respiration Biosignal Feedback - Study 3

This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application.

Participants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities.

Read more

Primary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time.

Participants will:

Complete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up.

Complete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors.

Some participants may receive additional in-app features designed to support personalized learning or engagement with training lessons.

Some participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.

Read the detailed description

Investigators will recruit young adults to participate in a study examining usability, engagement, and psychological outcomes associated with smartphone-based stress management or mindfulness training programs. Participants will be informed that the study examines physiological responses during guided digital training lessons.

At study entry, participants will complete an online survey assessing demographics, prior meditation and stress-management experience, and psychological well-being. Participants will complete similar questionnaires at post-intervention and one-month follow-up, including measures of user satisfaction and usability of the digital training platform using standardized instruments (e.g., System Usability Scale and Mobile App Rating Scale).

Participants will be individually randomized to one of several 14-day app-based training programs delivered through the Equa platform.

During training lessons, physiological data (e.g., motion-derived signals) will be collected using smartphone sensors to characterize physiological responses associated with lesson participation.

Some participants may receive additional in-app features designed to provide personalized information or feedback related to lesson engagement or training progress. These features are delivered automatically through the application following lesson completion.

Physiological and questionnaire measures will allow investigators to evaluate usability, engagement, and changes in mindfulness-related skills and psychological well-being associated with participation in the training programs.

Being tested
Equa, Feature-Enhanced Equa Training Program, Stress Management Training
Keywords
young adults, mental health, well-being, mindfulness skills, psychological distress, stress management
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EquaBehavioural

    Participants will be randomly assigned to a 14-unit smartphone meditation program group that involves completing a 2-10 minute daily guided practice on their phones. Participants complete 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app). Physiological measures will be tracked throughout the duration of lessons.

  • Feature-Enhanced Equa Training ProgramBehavioural

    Participants will be randomly assigned to complete a 14-unit smartphone-delivered guided training program consisting of brief daily lessons lasting approximately 2-10 minutes. Lessons are delivered through the Equa mobile application and focus on the development and practice of mindfulness skills designed to support concentration, awareness, and emotional well-being. Physiological data will be collected during lesson participation using smartphone sensors to characterize participant responses during guided activities. This program version includes additional in-app features designed to provide personalized visual information following lesson completion.

  • Stress Management TrainingBehavioural

    The CC program, called R\&R, is a well matched and previously validated digital stress management training. R\&R program lessons will focus on the development of three coping effectiveness skills: (a) thoughtful reflection; (b) reappraisal and reframing past and anticipated stressful events; and (c) problem solving, such as analyzing and solving personal problems.

Study groups in NCT07639697
Study groupRoleWhat they receive
Feature-Enhanced Equa TrainingExperimentalParticipants will complete a 14-day smartphone-delivered training program consisting of guided lessons through the Equa application. During lesson participation, physiological data will be collected using smartphone sensors to characterize participant responses during training activities. Participants assigned to this program version will receive additional in-app features designed to provide personalized information related to lesson engagement or training progress following lesson completion.
Receives: Behavioral: Feature-Enhanced Equa Training Program
Standard Equa Training ProgramActive comparatorParticipants will complete a 14-day smartphone-delivered training program consisting of guided lessons delivered through the Equa application. During lesson participation, physiological data will be collected using smartphone sensors to characterize participant responses during training activities. This program version provides the standard lesson experience within the application without additional personalized feedback features following lesson completion.
Receives: Behavioral: Equa
Stress Management Training ProgramActive comparatorParticipants will complete a 14-day smartphone-delivered training program focused on stress management and well-being skill development delivered through the Equa application. Lessons emphasize the development of evidence-informed coping skills, including thoughtful reflection, cognitive reappraisal of stressful experiences, and structured problem-solving strategies aimed at supporting adaptive responses to everyday stressors. Guided lessons are delivered through the same application interface and include comparable levels of interactivity and engagement activities as other study programs.
Receives: Behavioral: Stress Management Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Equa Program Engagement

    In order to evaluate differential engagement over the 21 day training period, we will sum total lessons (out of 14) and total minutes of training across lessons as primary outcome variables. One-way ANOVAs will compare conditions at post-treatment on each of these two engagement outcomes. ANOVA provides a simple and compelling tool but we will extend ANOVA results using survival analysis on lessons completed to detect training condition differences in the time points at which engagement significantly drops off.

    Measured: Throughout the 21 day training period

  2. Symptoms of Depression

    Mental distress will be measured over the past two weeks using the PHQ-8 to measure depression.

    The PHQ-8 allows participants respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks. Zero is equivalent to not at all and 3 indicates nearly every day.

    Measured: From baseline to 6 weeks after (1-month follow-up)

  3. Loneliness

    Loneliness will be measured using the UCLA 3-item Loneliness Scale. The UCLA Loneliness Scale allows participants indicate how often they feel the way described in each of the 3 statements using a 4-point scale that ranges from 1 never to 4 always. The scoring is continuous.

    Measured: From baseline to 6 weeks after (1-month follow-up)

  4. Anxiety

    Mental distress will be measured over the past two weeks using the GAD-7 to measure anxiety.

    The GAD-7 allows participants to respond to a questionnaire asking about how often they have been bothered by any of the listed problems over the last 2 weeks. Zero is equivalent to not at all and 3 indicates nearly every day.

    Measured: From baseline to 6 weeks after (1-month follow-up)

  5. Perceived Stress

    Mental distress will be measured over the past month using the Perceived Stress Scale to measure stress.

    The Perceived Stress Scale measures the degree to which situations in one's life are appraised as stressful during the last month. Zero is equivalent to never and 4 indicates very often.

    Measured: From baseline to 6 weeks after (1-month follow-up)

Secondary outcomes (7)
  1. User Satisfaction

    At post-treatment and follow-up, participants will complete measures of Equa user satisfaction using the 10-item SUS (and as a secondary user satisfaction measure, the 20-item MARS). Participants respond to the usability of a system by indicating the degree to which they agree or disagree with 10 statements using a 5-point scale that ranges from 1=strongly disagree to 5= strongly agree.

    Measured: From enrollment to the end of treatment at up to week 6

  2. Mean trait mindfulness as assessed by the Toronto Mindfulness Scale-Trait

    Participants respond to a questionnaire asking to what degree they agree with statements regarding curiosity and decentering. Zero is equivalent to not at all and four indicates very much. The sum of the items is taken for each of the two different aspects of mindfulness the TMS trait measures. A higher score indicates greater mindfulness and a lower score indicates lower mindfulness.

    Measured: From enrollment to the end of treatment at up to week 6

  3. State Trait Mindfulness Scores

    State mindfulness will be measured using two items from the Toronto Mindfulness Scale State (one from curiosity and one from decentering) following lessons within the app. The survey will use a 5-point Likert scale, 0 equal to not at all, and 4 equal to very much.

    Measured: Throughout the intervention (up to 3 weeks)

  4. Self-efficacy for practicing meditation or stress management

    To test our mechanistic account, we will also evaluate self-efficacy for practicing meditation or stress management by creating an adapted measure from the Self-Efficacy for Exercise Scale.

    Measured: From baseline to 6-weeks (1 month follow-up)

  5. Concentration, Sensory Clarity, and Equanimity

    Participants rate their average level of concentration, sensory clarity, and equanimity in every day life over the past two weeks. Scale: 1 (Low, Poor) - 5 (High, Excellent)

    Measured: From enrollment to the end of treatment at up to week 6

  6. Physical Pain

    Physical pain felt in the past 2-weeks will be captured using "From 0 no pain to 10 worst pain imaginable, how much pain, on average, have you experienced?". Zero is equivalent to no pain and 10 indicates the worst possible pain.

    Measured: From baseline to 6 weeks after (1-month follow-up)

  7. Extended Equa Program Engagement

    In order to evaluate differential engagement over the 21 day training period plus the 31 day follow up period, we will sum total lessons (out of 14) and total minutes of training across lessons as secondary outcome variables. One-way ANOVAs will compare conditions at end of follow-up period on each of these two engagement outcomes. ANOVA provides a simple and compelling tool but we will extend ANOVA results using survival analysis on lessons completed to detect training condition differences in the time points at which engagement significantly drops off.

    Measured: Throughout the 51 day intervention plus follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start17 Jun 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Investigators will evaluate whether differences in digital training program features are associated with changes in user satisfaction, engagement, and psychological outcomes. Participants will be individually randomized using a stratified 2:2:1 allocation sequence to one of several matched 14-day app-based training programs delivered through the Equa platform. Programs are comparable in branding, lesson length, platform navigation, and user experience, and include guided daily lessons focused on stress management and well-being skill development. During lesson participation, physiological data will be collected using smartphone sensors to characterize participant responses during training activities. Some program versions include additional in-app features designed to provide personalized information or feedback following lesson completion. Comparisons across program versions will evaluate usability, engagement, and changes in psychological well-being.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639697
Sponsor's protocol ID
12015
Other IDs
1R44MH134709-01A1
Status last verified
Jul 2026
First submitted
2 Jun 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The research team will only share de-identified data from our studies that allows outside groups to independently validate our claims in our published scientific articles. All data and documentation will be de-identified and will be consistent with applicable laws and regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Equa, Feature-Enhanced Equa Training Program and Stress Management Training in people with Psychological Distress and Mindfulness Skills, run by Equa Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juliette A Bonchonsky, BA (4125333601, juliette@equahealth.io), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Equa Program Engagement (time frame: Throughout the 21 day training period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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