STEPS - Stress Training and Engagement Via Phone-Based Systems
Mindfulness Training and Respiration Biosignal Feedback - Study 3
2 other identifiers
interventional
300
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedStudy Start
First participant enrolled
June 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
June 10, 2026
June 1, 2026
1.1 years
June 2, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Equa Program Engagement
In order to evaluate differential engagement over the 14 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.
Throughout the 14 day training period
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.
From baseline to 6 weeks after (1-month follow-up)
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.
From baseline to 6 weeks after (1-month follow-up)
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.
From baseline to 6 weeks after (1-month follow-up)
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.
From baseline to 6 weeks after (1-month follow-up)
Secondary Outcomes (6)
User Satisfaction
From enrollment to the end of treatment at up to week 6
Mean trait mindfulness as assessed by the Toronto Mindfulness Scale-Trait
From enrollment to the end of treatment at up to week 6
State Trait Mindfulness Scores
Throughout the intervention (up to 3 weeks)
Self-efficacy for practicing meditation or stress management
From baseline to 6-weeks (1 month follow-up)
Concentration, Sensory Clarity, and Equanimity
From enrollment to the end of treatment at up to week 6
- +1 more secondary outcomes
Study Arms (3)
Feature-Enhanced Equa Training
EXPERIMENTALParticipants 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.
Standard Equa Training Program
ACTIVE 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.
Stress Management Training Program
ACTIVE 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently pregnant
- Current or previous diagnosis with psychosis or schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Equa Healthlead
- Worcester Polytechnic Institutecollaborator
- National Institute of Mental Health (NIMH)collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Creswell, Ph.D.
Equa Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- A psychometrician and statistician on our team who will remain blind to participant study condition during data collection and analysis. All study investigators/staff will be blinded to condition assignment until randomization occurs; at this time only the participant and the project manager will be aware of participant's study condition. All other study personnel will remain blinded and conduct all remaining study assessments.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Founder, Chief Science Officer
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 10, 2026
Study Start
June 5, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The investigators will provide data within six months of any approved request.
- Access Criteria
- Scientific groups who aim to validate our findings can make requests for data access. The study team agrees that the names and Institutions of persons either given or denied access to the data, and the bases for such decisions, will be summarized in the annual progress reports.
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.