Pilot Study

We want to measure what happens—not assume it.

The first study is designed to establish feasibility and generate preliminary, carefully interpreted outcome data.

Initial design

A practical first step.

  • Approximately 20–40 participants
  • Initial focus on adults able to independently provide informed consent
  • Single-arm pre/post design unless an advisor recommends a comparison group
  • Standardized facilitator instructions and timing
  • Exploratory—not confirmatory—outcome analysis

Assessment schedule

T0

Before

Eligibility/safety check; minimal demographics; baseline well-being/social connection; optional behavioral task.

T1

Immediately after

Well-being; social connection; activity experience; satisfaction; optional behavioral task.

T2

1–2 week follow-up

Optional brief follow-up on well-being, usefulness, and continued use of activities.

Outcomes

What will we measure?

Feasibility

Recruitment, attendance, completion, burden, satisfaction, protocol fidelity, and unexpected events.

Participant experience

Well-being, social connection, meaningfulness, comfort, and perceived usefulness using appropriate measures.

Behavior & function

Simple repeatable indicators such as task completion or response latency, and validated cognitive tasks when justified.

Ethics & safety

Research participation must be voluntary and appropriately supervised.

Before research data are collected, the team should determine whether IRB/ethics review is required and establish informed-consent, privacy, safety, and data-management procedures. Future work involving minors, people with impaired decision-making capacity, or specific neurodegenerative/psychiatric populations will require additional protections and expert oversight.

Stronger Minds is not a crisis-response service and facilitators do not provide therapy.