The 28 Day Challenge

Study Overview
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Brief Summary
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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.

Official Title
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The 28 Day Challenge

Conditions
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Depression, Anxiety, Stress, Hope

Intervention / Treatment
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* Behavioral: Audio Content 1
* Behavioral: Audio Content 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Fluency Exclusion Criteria: Severe hearing impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1--October Start Audio Content 1<br>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<br>*  30 minute daily audio recordings of content 1 for 28 days<br>|
| Other: Group 2--November Start Audio Content 1<br>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<br>*  30 minute daily audio recordings of content 1 for 28 days<br>|
| Sham Comparator: Group 3--October Start Audio Content 2<br>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<br>*  30 minute daily audio recordings of content 2 for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |