These trials turn on dose and adherence: classes attended, minutes practised at home and questionnaires over time. Capture records attendance, home practice diaries and scales in one study, with assessor-blinded roles and an audit trail. Free sandbox, no card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Baseline | Wk 2 | Wk 4 | Wk 8 | Wk 16 |
|---|---|---|---|---|---|
| Class attendance (eCRF) | |||||
| Home practice log (phone) | D | D | D | ||
| Stress and mood scales | |||||
| Adverse experiences | |||||
| Assessor-blinded outcome visit |
x = done, D = participant diary. Demo data only.
What to plan for in a mind-body trial
Design
Common designs are an eight-week group programme versus a wait list, usual care or an active control such as a health education or exercise programme, with follow-up at the end of the programme and several months later. Yoga trials often vary class frequency, style and teacher, and mindfulness apps add a digital arm. The data system must support randomization, repeat visits and diaries, and clear rules about what counts as a completed session.
Capture handles the building blocks: randomization into arms (stratified and blinded randomization are part of the Full Platform plan on the pricing page), visit schedules with windows, ePRO diaries on the participant's phone, and blinded roles. See randomization, EDC for behavioral health studies, EDC for exercise intervention trials and EDC for lifestyle intervention trials.
Adherence
Teachers or coordinators record each class (attended, excused, make-up) on a repeating row; participants log home practice on their phone. Define in your protocol what counts as adequate dose, and Capture holds the raw data so you can derive it. The attendance form below is demo data.
Session
Attendance
Minutes in class
Reason if absent
Skipped when attended
Build a daily practice log in the free sandbox, preview it, and set the reminder schedule before you recruit.
Outcome measures
Examples only. Your protocol decides; each instrument has its own licence terms.
| Domain | Examples used in the literature | What to check in Capture |
|---|---|---|
| Perceived stress | Perceived Stress Scale (PSS) | Licence terms; participant questionnaire on the phone. |
| Mindfulness | FFMQ, MAAS | Licence terms and scoring rules; record scores as a calculated field if allowed. |
| Depression and anxiety | PHQ-9, GAD-7 | Templates exist; see the PHQ-9 and GAD-7 eCRFs. |
| Sleep | PSQI, Epworth Sleepiness Scale | Templates exist for both. |
| Pain and function | Numeric rating scales, disability indices | Linear scale and slider question types. |
| Physiology | Blood pressure, heart rate, HRV | Vitals eCRF; wearable data only where a device is connected. |
Capture does not verify licences or supply instrument text. For patient questionnaires you can record licence number, holder and expiry.
Blinding and bias
Participants and teachers know the intervention, so bias control relies on blinded outcome assessors, objective measures where possible, a credible control and pre-specified analyses. In Capture, blinded roles never receive treatment-arm values, enforced by masked database views, which lets an assessor complete outcome visits without seeing allocation. See blinded and unblinded role management and how to blind a clinical trial.
Self-reported practice logs are subject to recall and social desirability bias. If a more objective measure is available, such as attendance records or app-generated usage data, record it as a separate field so you can compare. Capture connects to wearables only through native OAuth for configured devices, and Oura is the device named on the site; do not assume others.
Safety and consent
A structured form for distress, flashbacks, pain or injury, reviewed by a clinician.
Eligibility form with checks for conditions your protocol excludes.
eConsent with email-code signature and investigator countersignature.
Coordinators see names; researchers see coded IDs.
Optional teacher form on delivery fidelity per session.
Set-up
Upload the protocol; the AI drafts visits and forms; you review every field.
Attendance rows, practice log diary, and a derived dose definition.
Add instruments you have the right to use; record licence details.
Assessor-blinded role, coordinator role, allocation rules.
Test with sample participants first; fees start only at go-live.
Yes. It can hold class attendance, a home practice diary, validated scales, assessor-blinded outcome visits and adverse experience forms in one study with an audit trail.
Use a participant diary on the phone for minutes practised and add attendance on a site form. Meta-analytic work reports that home practice is usually self-reported, so consider a separate objective measure where possible.
Yes. Blinded roles never see allocation values; participants and teachers cannot be blind to the intervention, so plan assessor blinding and a credible control.
Capture does not supply licensed instruments. Check each scale's terms, then build the questionnaire and record licence details for patient questionnaires.
Yes. The same attendance, diary, outcome and safety building blocks apply to yoga, tai chi and similar programmes, with injury and adverse event forms for physical practice.
The sandbox is free with every feature, no credit card, no time limit. Live-study pricing is listed on the pricing page.
Yes. Stratified and blinded randomization is part of the Full Platform plan on the pricing page; check the plan matches your design.
Keep exploring
Free sandbox for attendance, diaries and scales. No credit card; pay only at go-live.