Massive Individualized N-of-1 Experiments (MINEs) (MINEs)
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|ClinicalTrials.gov Identifier: NCT03695263|
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological Happiness Cognition||Behavioral: Choice of one of five behavioral interventions||Not Applicable|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|UC Davis Health|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Richard L Kravitz, MD, MSPH||UC Davis Division of General Medicine|