- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05719129
The Lasting Change Study
The Stanford Lasting Change Study
The study approach is to leverage the most cutting-edge techniques of multi-omics biology, wearable physiology, and digital real-time psychology profiling and using machine learning models to understand the mechanisms underlying the strategies and techniques that enable participants the power to initiate and maintain sustainable behavior change.
Over the years, millions of people worldwide have attended immersive personal development seminars aiming to improve participants' health behaviors and wellness. Nevertheless, there's a scarcity of large-scale studies to assess their effects on behavior change and investigate their mechanism of action. A recent publication by the Science of Behavior Change Program (SOBC), launched by the National Institute of Health (NIH), recognized that: "science has not yet delivered a unified understanding of basic mechanisms of behavior change across a broad range of health-related behaviors, limiting progress in the development and translation of effective and efficacious behavioral intervention." As such, understanding the mechanisms underlying sustainable behavior change is key.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-years-old and older
- English speaker
- Live in the US
- Participate in the DWD seminar (December 2-7, 2022)
Exclusion Criteria:
- Any physical or mental condition that limits the ability to participate in the study (e.g., answering e-questionnaires and wearing an electronic device)
- Serious active comorbidity or terminal illness
- Pregnancy
- Participation in any other clinical study focusing on psychological or behavioral intervention.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
DWD participants
Individuals that voluntarily chose to participate in DWD seminar.
|
6 days of immersive seminar
|
|
Matched control group
Individuals that voluntarily chose to from the US population matched by gender, age, education, ethnicity and income
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental performance biomarker index.
Time Frame: one-year
|
An algorithm will be used to create an index score using known biomarkers (psychosocial, physiological, and biological) related to participants' personalized mental performance.
Higher index scores will indicate a better mental performance index.
This outcome is assessed in the DWD group only.
|
one-year
|
|
Change from baseline in Oldenburg Burnout Inventory score (OLBI)
Time Frame: baseline through year one
|
Participant self-report burnout assessed by OBLI survey, a 16-item questionarie assesing disengagement and exhaustion with a score range of 16-64, where higher scores indicate higher burnout; assessed in all participants.
|
baseline through year one
|
|
Change from baseline in Percieved Stress Scale score (PSS-10)
Time Frame: baseline through year one
|
Participant self-report perceived stress assessed by the Perceived Stress Scale (PSS-10), a 10-item questionnaire with a score range of 0-40, where higher scores indicate greater perceived stress; assessed in all participants.
|
baseline through year one
|
|
Change from baseline in well-being score.
Time Frame: baseline through year one
|
Participant self-report well-being assessed by the PERMA-H Profiler, a 23-item questionnaire measuring psychological well-being across five domains: positive and negative emotions, engagement, relationships, meaning, and accomplishment (range 0-10 per item, higher scores indicate greater well-being); assessed in all participants.
|
baseline through year one
|
|
Change from baseline in subjective health score.
Time Frame: baseline through year one
|
Participant self-report subjective health assessed by the health domain in the PERMA-H Profiler (range 0-10 per item, higher scores indicate higher subjective health); assessed in all participants.
|
baseline through year one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-10)
Time Frame: baseline through year one
|
Participant self-report resilience assessed by CD-RISC-10 survey, a 10-item questionarie assesing resilience with a score range of 0 - 40, where higher scores indicate greater resilience; assessed in all participants.
|
baseline through year one
|
|
Change from baseline in General Self-Efficacy Scale (GSE-10)
Time Frame: baseline through year one
|
Participant self-report self-efficacy assessed by GSE-10 survey, a 10-item questionarie assesing self-efficacy with a score range of 0 - 40, where higher scores indicate greater self-efficacy; assessed in all participants.
|
baseline through year one
|
|
Change from baseline in Gratitude Questionnaire-Six Item Form (GQ-6)
Time Frame: baseline through year one
|
Participant self-report gratitude assessed by the GQ-6 survey, a 6-item questionnaire measuring gratitude with a score range of 6-42, where higher scores indicate higher levels of gratitude; assessed in all participants.
|
baseline through year one
|
|
Ecological Momentary Assessments (EMAs) score
Time Frame: baseline through year one
|
EMAs scores rated by participants to assess momentary mood and cognitive states.
This outcome is assessed in the DWD group only.
|
baseline through year one
|
|
Professional Fulfillment Index (PFI) score
Time Frame: baseline through year one
|
Participant self-report positive and negative facets of professional life assessed by PFI survey, a 16-item questionarie assesing fulfillment, work exhaustion, and interpersonal disengagement (range 0-4 per item).
This outcome is assessed in the DWD group only.
|
baseline through year one
|
|
WHO Quality of Life (WHO-QoL-BREF-26) score
Time Frame: baseline through year one
|
Participant self-report quality of life assessed by the WHO-QoL-BREF-26 questionnaire, a 26-item questionnaire measuring physical health, psychological health, social relationships, and environmental health (each domain scored from 4 to 20, with higher scores indicating better quality of life).
This outcome is assessed in the DWD arm only.
|
baseline through year one
|
|
Growth-Fixed Mindset score
Time Frame: baseline through year one
|
Participants self-report mindset assessed by the Growth and Fixed Mindset questionnaire, adapted to a 3-item questionnaire measuring growth/fixed mindset (higher scores indicating a stronger inclination toward a growth mindset).
This outcome is assessed in DWD arm only.
|
baseline through year one
|
|
Goals attainment score
Time Frame: baseline through year one
|
Participant self-report goals attainment assessed by the goals achievement survey, a 14-item questionarie assessing participants' attainment of specific goals (range 0-10 per item).
This outcome is assessed in the DWD group only.
|
baseline through year one
|
|
Human Needs score
Time Frame: baseline through year one
|
Participant self-report human needs assessed by the human needs survey, a 36-item questionnaire assessing participants' perceptions of their essential needs (range 0-10 per item).
This outcome is assessed in the DWD group only.
|
baseline through year one
|
|
Participants experiences and 0pinions
Time Frame: Up to 5 years after completion of the intervention
|
Semi-structered Interviews with participants about their personal experiences and opinions after the workshop.
This outcome will be assessed in DWD arm only.
|
Up to 5 years after completion of the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mike Snyder, PhD, Stanford University
- Principal Investigator: Shahar Lev-Ari, PhD, Stanford University & Tel-Aviv University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 66491, 68645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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