The 28 Day Challenge

Not Applicable

Withdrawn

• Conditions: Hope; Depression; Stress; Anxiety
• Interventions: Behavioral: Audio Content 2; Behavioral: Audio Content 1

• Registration Number: NCT03936946
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Study Start: 2020-06-10
• Primary Completion: 2020-07-10
• Study Completion: 2020-10-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• English Fluency

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Exclusion Criteria

• Severe hearing impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3--October Start Audio Content 2	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.
Group 1--October Start Audio Content 1	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
Group 2--November Start Audio Content 1	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.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale-10 (PSS-10)	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.
Change in Generalized Anxiety Disorder-7 (GAD-7)	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%.
Change in Patient Heath Questionnaire-9 (PHQ-9)	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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States