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Completed

NCT Number: NCT03695263

Massive Individualized N-of-1 Experiments (MINEs)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Health

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

There are no exclusion criteria, except that patients with pre-existing cardiovascular disease will be cautioned not to engage in new types of physical activity without consulting a physician.

Treatment and study plan

Choice of one of five behavioral interventions

Behavioral

All participants will choose one of the five intervention options.

Primary outcomes

  1. Stress

    Time frame: 18 days

    How stressed are you feeling today? (single item Likert scale).Stress will be measured using a single Likert-type question that ranges from 0-10, For stress 0 (not at all) represents a better outcome and 10 (as much as possible) represents a worse outcome.

  2. Focus

    Time frame: 18 days

    How focused are you feeling today? (single item Likert scale).Focus will be measured using a single Likert-type question that ranges from 0-10. For focus 0 (not at all) represents a worse outcome and 10 (as much as possible) represents a better outcome.

  3. Happiness

    Time frame: 18 days

    How happy are you feeling today? (single item Likert scale).Happiness will be measured using a single Likert-type question that ranges from 0-10. For happiness 0 (not at all) represents a worse outcome and 10 (as much as possible) represents a better outcome.

Secondary outcomes

  1. User burden

    Time frame: Within 1 to 28 days of N-of-1 trial completion

    User Burden Scale (UBS) - The UBS is a 20-item scale, with 6 individual sub-scales, that assesses the burden placed on users by computing systems. The 6 burden-related constructs evaluated through the sub-scales are: (1) difficulty of use (2) physical (3) time and social (4) mental and emotional (5) privacy (6) financial The UBS uses two 5-point scales ranging from 0-4 (Never - All of the time; Not at all - Extremely). Total score is a sum of responses to all questions in the scale. A higher score indicates a higher level of user burden. The maximum score is 80 and minimum is 0.

    User burden can be explored by sub-scales to explore which construct is contributing most to user burden. In such a case, scores for each sub-scale are computed by calculating the mean for items within each sub-scale.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Brown University
  • University of California, San Diego
  • University of California, San Francisco

Registry information

Official study title

Massive Individualized N-of-1 Experiments Using HackYourHealth: A New Paradigm for Promoting Health and Well-Being

Acronym: MINEs

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2018
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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