NCT04172051

Brief Summary

This study will consist of a randomized experimental group and a control group, In addition to the control and experimental group, there will also be a non-randomized motivated experimental group. Approximately 75 males and females from the ages of 18 to 80 will take part in this study. Subjects will be randomly divided into a Control and Experimental Group. Subjects for the control and experimental group will be recruited from a Tony Robbins Facebook page, and subjects in the experimental group (DWD Group) will be admitted to the Tony Robbins Date With Destiny Event (December 2019) in West Palm Beach for free, while the subjects randomly assigned to the control group, will not attend the event, but instead be required to a Gratitude Journaling experiment (Three Good Things Intervention). Psychological assessment surveys will be taken before the event, directly after the event, and one month following the event. The control group will take the psychological assessment before beginning journaling, directly after completing journaling, and one month following completion of journaling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

November 18, 2019

Last Update Submit

July 10, 2020

Conditions

Outcome Measures

Primary Outcomes (17)

  • Changes in Patient Health Questionnaire - 9 (PHQ-9)

    The PHQ-9 is a self-administered survey used for diagnosing depression and assessing depression severity. It measures each of the 9 Diagnostic and Statistical Manual of Mental Disorders-IV/V diagnostic criteria for depression on a 0-3 scale. Depression Severity is measured as follows: 0 none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against structured clinical interviews. PHQ-9 scores ≥10 exhibited a sensitivity of 88% and a specificity of 88% for major depression.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Date With Destiny Survey

    Subjects will be asked if they have been to DWD or Not Been to DWD

    Pre - Event

  • Tony Robbins Events Survey

    Subjects will be asked if they have been to any Tony Robbins events or not.

    Pre - Event

  • Tony Robbins Priming Techniques Survey

    DWD subjects will be asked if they continued to use Tony Robbins Priming techniques daily for a month.

    1 Month Post - Event

  • Changes in Generalize Anxiety Disorder - 7 (GAD-7)

    The GAD-7 is a self report-based survey that assesses generalized anxiety disorder and severity on a 7-item scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was compared to diagnoses by mental health professionals. Using scores \>/= 10, It has sensitivity of 89% and specificity of 82%.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Perceived Stress Scale (PSS-10)

    The Perceived Stress Scale-10 (PSS-10) measures global perceived stress via self-report on a ten item scale. Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Total scores ranging from 0-13 would be considered low stress. Total scores ranging from 14-26 would be considered moderate stress. Total scores ranging from 27-40 would be considered high perceived stress.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in PERMA Profiler

    The scale measures five aspects of well-being defined by Martin Seligman, PERMA - positive emotion, engagement, relationships, meaning, and accomplishment, as well as negative emotion and health.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Dysfunctional Attitudes Scale - 17 (DAS-17)

    The Attitudes Scale-17 is a short form version of the DAS-A rated on a 7-point Likert scale (7 = fully agree; 1 = fully disagree). It is comprised of two subscales, perfectionism (11-77) and dependency (6-35), as well as a total score (17-119). Higher scores indicate higher levels of dysfunctional attitudes.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Primals Inventory -18 (PI-18)

    The Primal World Beliefs Index-18 is a short form version of the PI-99 that measures beliefs about the world in general through four constructs, Safe, Enticing, and Alive, and the overall construct, Good. Each construct is on a scale of 0-5, with higher scores indicating higher levels of Good, Safe, Enticing, and Alive.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Satisfaction with Life Survey

    The Satisfaction with life scale is a five question survey scored on a 7-point Likert scale with scores ranging from 5-35, with 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. The coefficient alpha for the scale has ranged from .79 to .89, indicating that the scale has high internal consistency. The scale was also found to have good test-retest correlations (.84, .80 over a month interval).

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Close Relationships Questionnaire

    The Close Relationships Questionnaire is a 36 question survey that measures attachment anxiety and attachment avoidance. It is scored on a Likert scale from 1 to 7 with total scores ranging from 36 to 252.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Sexual Satisfaction

    The sexual satisfaction scale is a 4 question scale on a six point Likert scale ranging from extremely dissatisfied to extremely satisfied, with scores ranging from 4 to 24. Higher scores indicate higher sexual satisfaction. The scale is a brief assessment of sexual satisfaction and shouldn't be used for studies focused on sexuality.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Adult Hope Scale

    The Adult Hope Scale is a 12 item scale on an 8 point Likert scale ranging from definitely false to definitely true with scores ranging from 12 to 96. Higher scores indicate a higher positive motivational state. The scale seeks to measure hope in terms of motivation.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Gratitude Questionnaire

    The Gratitude Questionnaire is a 6 item questionnaire scored on a 7 point Likert scale ranging from strongly disagree to strongly agree with scores ranging from 6 to 42. Higher scores indicate more gratitude experienced in daily life. The scale seeks to measure differences in proneness to experience gratitude in daily life.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Adverse Childhood Experience (ACE)

    The Adverse Childhood Experiences questionnaire is a ten question survey assessing incidence of common traumas before age 18. Scores range from 0-10, with higher scores indicating higher levels of childhood trauma.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Date With Destiny - Specific Surveys

    Date With Destiny - Specific Surveys will be used to assess specific and measurable before and after psychometric, health, and lifestyle changes.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

  • Changes in Short Form Survey-36 (SF-36)

    Health Status Questionnaire will be used to assess changes in health before and after the event.

    Pre - Event, 24 hours Post - Event, 1 Month Post - Event

Study Arms (3)

Experimental Group

EXPERIMENTAL

Subjects will be admitted into the Tony Robbins event for free, or receive a voucher for an event in the future. The experimental group will attend the event. Subjects will be exposed to a variety of mind-body exercises and psychoeducational content including neural linguistic programming, designed to motivate, inspire, and improve the quality of people's lives. After attending the event, the experimental group will be asked to continue practicing "Priming " daily for a month. A One-page "priming" cheat sheet will be given to the subjects in the experimental group.

Behavioral: Tony Robbins Date with Destiny

Control Group

NO INTERVENTION

The control group will be asked to engage in gratitude journaling every day for a month. The control group will NOT attend the event. This exercise will take 10 minutes to complete. The subject will write down three things that went well each day and provide an explanation about why they went well. This will be written down in a journal. The subjects will follow these instructions: 1. Give the event a title (e.g., "co-worker complimented my work on a project") 2. In the space below, write down exactly what happened in as much detail as possible, including what you did or said, and if other people were involved, what they did or said. 3. Include how this event made you feel at the time and how this event made you feel later (including now, as you remember it).

Motivated Experimental Group

ACTIVE COMPARATOR

The Motivated Experimental Group (M Experimental) will consist of participants who registered and paid for Tony Robbins Date with Destiny (DWD). They are chosen as the motivated experimental as they will be paying full price for the event. The experimental group will attend the event. Subjects will be exposed to a variety of mind-body exercises and psychoeducational content including neural linguistic programming, designed to motivate, inspire, and improve the quality of people's lives. After attending the event, the experimental group will be asked to continue practicing "Priming " daily for a month. A One-page "priming" cheat sheet will be given to the subjects in the experimental group.

Behavioral: Tony Robbins Date with Destiny

Interventions

DWD is a 6-day immersive transformational experience led by Tony Robbins. It will be held at the PALM BEACH, FLORIDA Convention Center from December 5th through December 10th. Subjects will be exposed to a variety of mind-body exercises and psychoeducational content including neural linguistic programming, designed to motivate, inspire, and improve the quality of people's lives.

Experimental GroupMotivated Experimental Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18+, male and female, English speaking, lives in the U.S.
  • Experimental group: must be a registered participant in Tony Robbins Palm Beach DWD (Dec 5th-10th)
  • Control group: PHQ 9 score \> 4 (5 is the cutoff for mild depression).

You may not qualify if:

  • Excluded from the experimental group if you DO NOT attend the event.
  • Excluded from the control group if you DO attend the event.
  • Excluded from the Motivated Experimental Group if they have been compensated for their admissions fee.
  • No confounding medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University Department of Genetics

Stanford, California, 94305, United States

Location

The Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

Palm Beach County Convention Center

West Palm Beach, Florida, 33401, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 21, 2019

Study Start

November 25, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations