iWellness Study to Evaluate a Mental Health App for Students

Completed · Not applicable · Has a placebo group

Conditions studied: Depression, Anxiety

In brief

The study aims to evaluate whether use of a mobile mental health app improves outcomes of depression and anxiety for students.

Key facts

Study ID

NCT05234970

Run by

Harvard University

People needed

289

Starts

2022-02-24

Expected to finish

2022-12-31

Last updated by the study team

2023-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants will be required to be at 18 years or older
• Own a smartphone with Wi-Fi or 3G/4G capabilities
• Current student at Harvard University
• A PHQ-9 score of 5 or greater (indicating mild symptoms of depression or greater), or a score of 2 or greater on PHQ item 10 (indicating that they felt disabled in their life because of their mood) or a GAD-7 score of 8 or greater (indicating mild symptoms of anxiety or greater) will be required for enrollment.

You may not qualify if…

• Those who score less than 5 on PHQ-9 or less than 8 on the GAD-7 during study screening will be excluded from the study.
• Anyone who indicates thoughts of harm to themselves or others (PHQ-9 item 9 score > 0) during initial screening will be excluded from participation in the study.
• Participants with a PHQ-9 Q9 suicide item score > 0 will receive an automated notification that they are not eligible to participate in the study and that they should call the Harvard Counseling and Mental Health Services 24/7 line. Study staff will also inform Chief of HUHS CAMHS to reach out to the participant.

Where it is running

• Harvard University Health Services — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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