Massive Individualized N-of-1 Experiments (MINEs)

NCT03695263 | Completed

• 1 other identifier: 1255435
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress, Psychological; Happiness; Cognition

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• User burden

  Within 1 to 28 days of N-of-1 trial completion

Study Arms (1)

N-of-1 Trial

EXPERIMENTAL

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

Interventions

Choice of one of five behavioral interventions BEHAVIORAL

All participants will choose one of the five intervention options.

N-of-1 Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Francisco: collaborator
• University of California, San Diego: collaborator
• Brown University: collaborator

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Richard L Kravitz, MD, MSPH

  UC Davis Division of General Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: April 15, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)