Massive Individualized N-of-1 Experiments (MINEs)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2019-12-30

Brief Summary

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The project will enroll up to 10,000 adult volunteers in individualized experiments (N-of-1 trials) designed to assess the individual-level effects of any of five interventions on three outcomes. The five interventions are: gratitude journaling, mindfulness meditation, random acts of kindness, physical activity, and laughter therapy. The three outcomes are stress, cognitive focus, and happiness. Each participant will engage in the selected activity in 3 day intervals, separated at random by 3 day intervals of usual activity, for a total of six 3-day periods (18 days).

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Detailed Description

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N-of-1 trials (single patient crossover experiments) are a uniquely powerful technique for estimating treatment effects in the individual. N-of-1 trials have been offered to hundreds or perhaps thousands of patients worldwide, but never at scale. HackYourHealth is a tool that supports the conduct of simple N-of-1 self-experiments to test if healthy activities that work in general (i.e., mindfulness meditation, physical activity, gratitude journaling, random acts of kindness, and laughter therapy), improve psychological well-being (stress, focus, happiness) in specific individuals. The tool supplies the experimental design, facilitates data analysis, and channels feedback to participants. The tool is flexible enough to support Massive Individualized N-of-1 Experiments (MINEs) at scale. Working with WNYC Radio in New York City, we will recruit and run 18-day N-of-1 trials up to 10,000 individuals. The purpose of this study is to conduct a formative evaluation of HackYourHealth in terms of its perceived usefulness and to explore heterogeneity in intervention response across the sample. We anticipate that the results will: 1) identify useful behavioral interventions for individual participants; 2) help to estimate generalizable treatment effects for the interventions of interest; 3) assess heterogeneity of treatment effects across subgroups; and 4) elucidate the user experience with N-of-1 trials. When complete, the study will support additional proposals designed to assess the utility of MINEs as applied to additional conditions and treatments.

Conditions

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Stress, Psychological Happiness Cognition

Study Design

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Intervention Model

SEQUENTIAL

Each participant will enroll in a personalized ("N-of-1") crossover trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The analysis will proceed automatically without knowledge of which 3-day treatment periods were associated with one of the five interventions and which were associated with the subject's usual activities.

Study Groups

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N-of-1 Trial

Multiple crossovers between one of the available intervention options (mindfulness meditation, gratitude journaling, physical activity, laughter therapy, or random acts of kindness) and usual activities

Group Type EXPERIMENTAL

Choice of one of five behavioral interventions

Intervention Type BEHAVIORAL

All participants will choose one of the five intervention options.

Interventions

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Choice of one of five behavioral interventions

All participants will choose one of the five intervention options.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 or over
* Living anywhere in the United States
* Using a smartphone
* Having regular access to internet on their phone
* Able to read and write in English

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes