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NCT Number: NCT07639697

STEPS - Stress Training and Engagement Via Phone-Based Systems

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.

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.

Recruiting

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Equa

Behavioral

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 Program

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. Equa Program Engagement

    Time frame: Throughout the 21 day training period

    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.

  2. Symptoms of Depression

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

    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.

  3. Loneliness

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

    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.

  4. Anxiety

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

    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.

  5. Perceived Stress

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

    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.

Secondary outcomes

  1. User Satisfaction

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

    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.

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

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

    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.

  3. State Trait Mindfulness Scores

    Time frame: Throughout the intervention (up to 3 weeks)

    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.

  4. Self-efficacy for practicing meditation or stress management

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

    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.

  5. Concentration, Sensory Clarity, and Equanimity

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

    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)

  6. Physical Pain

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

    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.

  7. Extended Equa Program Engagement

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Creswell, Ph.D.

CONTACT

[email protected]

4125353338

Juliette A Bonchonsky, BA

CONTACT

[email protected]

4125333601

Sponsors and collaborators

Lead sponsor

Equa Health

Industry

Collaborators

  • National Institute of Mental Health (NIMH)
  • Worcester Polytechnic Institute

Registry information

Official study title

Mindfulness Training and Respiration Biosignal Feedback - Study 3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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