STEPS - Stress Training and Engagement Via Phone-Based Systems
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.
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: David Creswell, Ph.D.
- Telefonní číslo: 4125353338
- E-mail: david@equahealth.io
Studijní záloha kontaktů
- Jméno: Juliette A Bonchonsky, BA
- Telefonní číslo: 4125333601
- E-mail: juliette@equahealth.io
Studijní místa
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- Nábor
- 4615 Forbes Ave
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Kontakt:
- Juliette Bonchonsky, B.A.
- Telefonní číslo: 4125333601
- E-mail: juliette@equahealth.io
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Kontakt:
- David Creswell, PhD
- Telefonní číslo: 4125353338
- E-mail: david@equahealth.io
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Feature-Enhanced Equa Training
Participants 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.
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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.
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Aktivní komparátor: Standard Equa Training Program
Participants 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.
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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.
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Aktivní komparátor: Stress Management Training Program
Participants 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Symptoms of Depression
Časové okno: From baseline to 6 weeks after (1-month follow-up)
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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)
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Loneliness
Časové okno: From baseline to 6 weeks after (1-month follow-up)
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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.
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From baseline to 6 weeks after (1-month follow-up)
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Anxiety
Časové okno: From baseline to 6 weeks after (1-month follow-up)
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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)
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Perceived Stress
Časové okno: From baseline to 6 weeks after (1-month follow-up)
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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)
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Equa Program Engagement
Časové okno: Throughout the 21 day training period
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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.
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Throughout the 21 day training period
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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User Satisfaction
Časové okno: From enrollment to the end of treatment at up to week 6
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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.
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From enrollment to the end of treatment at up to week 6
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Mean trait mindfulness as assessed by the Toronto Mindfulness Scale-Trait
Časové okno: From enrollment to the end of treatment at up to week 6
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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.
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From enrollment to the end of treatment at up to week 6
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State Trait Mindfulness Scores
Časové okno: Throughout the intervention (up to 3 weeks)
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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.
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Throughout the intervention (up to 3 weeks)
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Self-efficacy for practicing meditation or stress management
Časové okno: From baseline to 6-weeks (1 month follow-up)
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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.
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From baseline to 6-weeks (1 month follow-up)
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Concentration, Sensory Clarity, and Equanimity
Časové okno: From enrollment to the end of treatment at up to week 6
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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)
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From enrollment to the end of treatment at up to week 6
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Physical Pain
Časové okno: From baseline to 6 weeks after (1-month follow-up)
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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.
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From baseline to 6 weeks after (1-month follow-up)
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Extended Equa Program Engagement
Časové okno: Throughout the 51 day intervention plus follow-up period.
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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.
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Throughout the 51 day intervention plus follow-up period.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: David Creswell, Ph.D., Equa Health
Termíny studijních záznamů
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Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První zveřejněno (Aktuální)
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12015
- 1R44MH134709-01A1 (Grant/smlouva NIH USA)
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