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Active, Not Recruiting

NCT Number: NCT05719129

The 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psychological Wellness Behavior Multiomics Personal Satisfaction Personal and Professional Fulfilment Psychological Well-Being Resilience, Psychological Wearable Devices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford university

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Date With Destiny (DWD) Seminar

Behavioral

6 days of immersive seminar

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

The Stanford Lasting Change Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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