An interventional study of Audio Content 1 and Audio Content 2 in Depression, Anxiety and Stress, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
Browse Depression studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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
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
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 1 for 28 days
\~30 minute daily audio recordings of content 2 for 28 days
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
Time frame: 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
Time frame: 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%.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months
Plan to share: No — No current plan to share data
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This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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