STEPS - Stress Training and Engagement Via Phone-Based Systems

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorEqua Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18-30 years of Age

Fluent in English

Psychological distress

Interested in completing smartphone guided training sessions remotely for 14 days

Disqualifiers

Currently pregnant

Current or previous diagnosis with psychosis or schizophrenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Feature-Enhanced Equa TrainingExperimental treatment 1 intervention
Group B: Standard Equa Training ProgramActive comparator 1 intervention
Group C: Stress Management Training ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Equa Health

Lead sponsor

Worcester Polytechnic Institute

Collaborator

National Institute of Mental Health (NIMH)

Collaborator