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Behavioral Intervention
Mental Health App for Depression in Cancer Survivors (MACS Trial)
N/A
Recruiting
Led By Earlise Ward, MS, PhD, LP
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 22 years at the time of consent
Be older than 18 years old
Must not have
Unable to read and speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a digital app for mental health on head and neck cancer patients to help treat depression. Participants will use the app for 6 weeks and fill out surveys. "This trial tests
Who is the study for?
This trial is for adults over the age of 22 who have a history of head and neck cancer (HNC) confirmed by medical records. They must be experiencing moderate to severely moderate depression, with specific scores on a health questionnaire (PHQ-9). Participants need to commit to the study's procedures and timeline.
What is being tested?
The IONA Mind app, a digital mental health application, is being tested for its effectiveness in treating depression among patients and survivors of head and neck cancer. Users will engage with the app over six weeks while also completing related surveys.
What are the potential side effects?
As this intervention involves using a mental health app, side effects may not be as common as with medications but could include discomfort or emotional distress from engaging with content designed to address depressive symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot read or speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Patient Health Questionnaire-9 (PHQ-9)
Feasibility: IONA Mind app Utilization in Minutes
Feasibility: Measured by Retention rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IONA Mind appExperimental Treatment1 Intervention
Participants will be asked to use the IONA Mind app for a 6-week period.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,435 Total Patients Enrolled
86 Trials studying Depression
66,651 Patients Enrolled for Depression
University of Wisconsin, MadisonLead Sponsor
1,228 Previous Clinical Trials
3,198,508 Total Patients Enrolled
24 Trials studying Depression
10,566 Patients Enrolled for Depression
Earlise Ward, MS, PhD, LPPrincipal InvestigatorUniversity of Wisconsin, Madison
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