Psychological WellnessNCT05719129
The Lasting Change Study
An observational study of Psychological Wellness and Resilience, Psychological, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Wellness, Resilience, Psychological, Personal and Professional Fulfilment
- What is being tested?
- Date With Destiny (DWD) Seminar
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,445 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals that voluntarily chose to participate in DWD seminar.
Who may be able to join
- 18-years-old and older
- English speaker
- Live in the US
- Participate in the DWD seminar (December 2-7, 2022)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Psychological Wellness, Resilience, Psychological, Personal and Professional Fulfilment, Wearable Devices, Multiomics
- Being tested
- Date With Destiny (DWD) Seminar
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date With Destiny (DWD) SeminarBehavioural
6 days of immersive seminar
| Study group | Role | What they receive |
|---|---|---|
| DWD participants | Individuals that voluntarily chose to participate in DWD seminar. Receives: Behavioral: Date With Destiny (DWD) Seminar | |
| Matched control group | Individuals that voluntarily chose to from the US population matched by gender, age, education, ethnicity and income |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental performance biomarker index.
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.
Measured: one-year
Change from baseline in Oldenburg Burnout Inventory score (OLBI)
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.
Measured: baseline through year one
Change from baseline in Percieved Stress Scale score (PSS-10)
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.
Measured: baseline through year one
Change from baseline in well-being score.
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.
Measured: baseline through year one
Change from baseline in subjective health score.
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.
Measured: baseline through year one
Secondary outcomes (10)
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-10)
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.
Measured: baseline through year one
Change from baseline in General Self-Efficacy Scale (GSE-10)
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.
Measured: baseline through year one
Change from baseline in Gratitude Questionnaire-Six Item Form (GQ-6)
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.
Measured: baseline through year one
Ecological Momentary Assessments (EMAs) score
EMAs scores rated by participants to assess momentary mood and cognitive states. This outcome is assessed in the DWD group only.
Measured: baseline through year one
Professional Fulfillment Index (PFI) score
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.
Measured: baseline through year one
WHO Quality of Life (WHO-QoL-BREF-26) score
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.
Measured: baseline through year one
Growth-Fixed Mindset score
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.
Measured: baseline through year one
Goals attainment score
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.
Measured: baseline through year one
Human Needs score
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.
Measured: baseline through year one
Participants experiences and 0pinions
Semi-structered Interviews with participants about their personal experiences and opinions after the workshop. This outcome will be assessed in DWD arm only.
Measured: Up to 5 years after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological WellnessStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Snyder, Stanford University
- Investigators
- Mike Snyder, PhD, Principal investigator, Stanford UniversityShahar Lev-Ari, PhD, Principal investigator, Stanford University & Tel-Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719129
- Sponsor's protocol ID
- 66491, 68645
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available from the corresponding authors upon reasonable request. To protect participant privacy, individual-level data are not publicly available due to the sensitive nature of psychological and health-related information. Aggregated data and analysis scripts used to generate the main results and figures will be deposited in a public repository upon publication. Any additional data or materials required to replicate the reported findings that are not included in the public repository will be made available by the corresponding authors upon reasonable request, subject to institutional review board approval for sharing of de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stanford Lasting Change Study
- ClinicalTrials.gov ID
- NCT05719129
- Acronym / sponsor ID
- 66491, 68645
- Conditions
- Psychological Wellness, Resilience, Psychological, Personal and Professional Fulfilment, Wearable Devices, Multiomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,445 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWD participants | – | Behavioral: Date With Destiny (DWD) SeminarIndividuals that voluntarily chose to participate in DWD seminar. |
| Matched control group | – | –Individuals that voluntarily chose to from the US population matched by gender, age, education, ethnicity and income |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals that voluntarily chose to participate in DWD seminar.
Key inclusion criteria (4 listed)
- 18-years-old and older
- English speaker
- Live in the US
- Participate in the DWD seminar (December 2-7, 2022)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date With Destiny (DWD) Seminar6 days of immersive seminar | Behavioural | DWD participants |
Primary outcome
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.
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.
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.
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.
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.
10 secondary outcomes
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-10)
Time frame: baseline through year one
Change from baseline in General Self-Efficacy Scale (GSE-10)
Time frame: baseline through year one
Change from baseline in Gratitude Questionnaire-Six Item Form (GQ-6)
Time frame: baseline through year one
Ecological Momentary Assessments (EMAs) score
Time frame: baseline through year one
Professional Fulfillment Index (PFI) score
Time frame: baseline through year one
WHO Quality of Life (WHO-QoL-BREF-26) score
Time frame: baseline through year one
Growth-Fixed Mindset score
Time frame: baseline through year one
Goals attainment score
Time frame: baseline through year one
Human Needs score
Time frame: baseline through year one
Participants experiences and 0pinions
Time frame: Up to 5 years after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available from the corresponding authors upon reasonable request. To protect participant privacy, individual-level data are not publicly available due to the sensitive nature of psychological and health-related information. Aggregated data and analysis scripts used to generate the main results and figures will be deposited in a public repository upon publication. Any additional data or materials required to replicate the reported findings that are not included in the public repository will be made available by the corresponding authors upon reasonable request, subject to institutional review board approval for sharing of de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Snyder, PhD principal investigator
Stanford University
Shahar Lev-Ari, PhD principal investigator
Stanford University & Tel-Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Wellness and Resilience, Psychological, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental performance biomarker index. (time frame: one-year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.