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Massive Individualized N-of-1 Experiments (MINEs) (MINEs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695263
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
University of California, San Francisco
University of California, San Diego
Brown University
Information provided by (Responsible Party):
University of California, Davis

Brief 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).

Condition or disease Intervention/treatment Phase
Stress, Psychological Happiness Cognition Behavioral: Choice of one of five behavioral interventions Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Each participant will enroll in a personalized ("N-of-1") crossover trial.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Massive Individualized N-of-1 Experiments Using HackYourHealth: A New Paradigm for Promoting Health and Well-Being
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: 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
Behavioral: Choice of one of five behavioral interventions
All participants will choose one of the five intervention options.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695263


Locations
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United States, California
UC Davis Health
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
University of California, San Diego
Brown University
Investigators
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Principal Investigator: Richard L Kravitz, MD, MSPH UC Davis Division of General Medicine
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03695263    
Other Study ID Numbers: 1255435
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms