Massive Individualized N-of-1 Experiments (MINEs)

Stress, Psychological Clinical Trial

— MINEs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695263
• Other study ID #: 1255435
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Happiness
• Stress, Psychological

Intervention

Behavioral:
• Choice of one of five behavioral interventions
All participants will choose one of the five intervention options.

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	Brown University, University of California, San Diego, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress	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.	18 days
Primary	Focus	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.	18 days
Primary	Happiness	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.	18 days
Secondary	User burden	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.	Within 1 to 28 days of N-of-1 trial completion