The 28 Day Challenge

Depression Clinical Trial

Official title:

The 28 Day Challenge

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03936946
• Other study ID #: 50298
• Status: Withdrawn
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English Fluency

Exclusion Criteria:

• Severe hearing impairment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Hope
• Stress

Intervention

Behavioral:
• Audio Content 1
~30 minute daily audio recordings of content 1 for 28 days
• Audio Content 2
~30 minute daily audio recordings of content 2 for 28 days

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Heath 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 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	Baseline, 1 months
Primary	Change in Patient Heath 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 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	Baseline, 3 months
Primary	Change in Generalized 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%.	Baseline, 1 months
Primary	Change in Generalized 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%.	Baseline, 3 months
Primary	Change in Perceived Stress Scale-10 (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.	Baseline, 1 months
Primary	Change in Perceived Stress Scale-10 (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.	Baseline, 3 months