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The 28 Day Challenge

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ClinicalTrials.gov Identifier: NCT03936946
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Snyder, Stanford University

Brief Summary:
The purpose of this study is to determine how a 28 Day Challenge influences mental health and well-being. This is a blinded study. Participants both with and without depression and anxiety, will be included. A moderation analysis will be performed to see whether changes in depression after the intervention are a function of baseline depression and anxiety levels.

Condition or disease Intervention/treatment Phase
Depression Anxiety Stress Hope Behavioral: Audio Content 1 Behavioral: Audio Content 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to Group 1, Group 2, or Group 3. Group 1 begins the 28 day challenge in October (while group 2 acts as a passive control) and Group 2 begins the 28 day challenge 1 months late (while Group 1 receives no further intervention). Group 3 will begin the 28 day challenge concurrent with Group 1, but will listen to different audio clips than Group 1 (blinded).
Masking: Single (Participant)
Masking Description: Participants will not be told what the intervention is until they are assigned (i.e. each group will not know what they will be listening to ahead of time or what other groups are listening to).
Primary Purpose: Treatment
Official Title: The 28 Day Challenge
Estimated Study Start Date : October 10, 2019
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Group 1--October Start Audio Content 1
This group will listen to audio content 1 daily for 28 days beginning in October, and then will receive no further intervention
Behavioral: Audio Content 1
~30 minute daily audio recordings of content 1 for 28 days

Group 2--November Start Audio Content 1
This group will not be assigned to any interventions during the first month of the trial and will act as a passive control group at that time. They will be assigned to listen to audio content 1 daily for 28 days beginning in November.
Behavioral: Audio Content 1
~30 minute daily audio recordings of content 1 for 28 days

Sham Comparator: Group 3--October Start Audio Content 2
This group will listen to audio content 2 daily for 28 days beginning in October, and then will receive no further intervention.
Behavioral: Audio Content 2
~30 minute daily audio recordings of content 2 for 28 days




Primary Outcome Measures :
  1. Change in Patient Heath Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 1 months ]

    The PHQ-9 is a self-administered survey used for diagnosing depression and assessing depression severity. It measures each of the 9 DSM-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.

    DSM = The Diagnostic and Statistical Manual of Mental Disorders


  2. Change in Patient Heath Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 3 months ]

    The PHQ-9 is a self-administered survey used for diagnosing depression and assessing depression severity. It measures each of the 9 DSM-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.

    DSM = The Diagnostic and Statistical Manual of Mental Disorders


  3. Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, 1 months ]
    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%.

  4. Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, 3 months ]
    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%.

  5. Change in Perceived Stress Scale-10 (PSS-10) [ Time Frame: Baseline, 1 months ]
    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.

  6. Change in Perceived Stress Scale-10 (PSS-10) [ Time Frame: Baseline, 3 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English Fluency

Exclusion Criteria:

  • Severe hearing impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936946


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Contact: Ariel Ganz, PhD    650-736-8099    abganz@stanford.edu   
Sub-Investigator: Ariel Ganz, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Michasel Snyder, PhD Stanford University
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Responsible Party: Michael Snyder, Chairman and Professor of Genetics, Stanford University
ClinicalTrials.gov Identifier: NCT03936946    
Other Study ID Numbers: 50298
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms