The 28 Day Challenge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Stanford University
- Locations
- 2
- Primary Endpoint
- Change in Perceived Stress Scale-10 (PSS-10)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •English Fluency
Exclusion Criteria
- •Severe hearing impairment
Outcomes
Primary Outcomes
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.
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%.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Snyder
Chairman and Professor of Genetics
Stanford University