Anxiety, Depression, Hope, Stress
Conditions
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.
Interventions
BEHAVIORALAudio Content 1
\ 30 minute daily audio recordings of content 1 for 28 days
BEHAVIORALAudio Content 2
\ 30 minute daily audio recordings of content 2 for 28 days
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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).
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English Fluency
Exclusion criteria
* Severe hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Heath Questionnaire-9 (PHQ-9) | Baseline, 1 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 |
| Change in Generalized Anxiety Disorder-7 (GAD-7) | Baseline, 1 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 Perceived Stress Scale-10 (PSS-10) | Baseline, 1 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. |
Countries
United States
Outcome results
None listed