The 28 Day Challenge

• ClinicalTrials.gov Identifier: NCT03936946
• Recruitment Status: Withdrawn
• First Posted: May 3, 2019
• Last Update Posted: May 26, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Michael Snyder, Stanford University

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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: June 10, 2020
• Estimated Primary Completion Date: July 10, 2020
• Estimated Study Completion Date: October 10, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Michasel Snyder, PhD; Stanford University

More Information

• 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
• Last Update Posted: May 26, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No current plan to share data

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms