30 Participants Needed

Mental Health App for Depression in Cancer Survivors

(MACS Trial)

CC
Overseen ByCancer Connect
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications?

The trial excludes people using prescription medicine for depression, so you cannot be on such medications to participate.

What data supports the idea that Mental Health App for Depression in Cancer Survivors is an effective treatment?

The available research shows that app-based interventions can be effective for cancer survivors dealing with depression. For example, a pilot study on a similar app-based stress management program called StressProffen found significant reductions in stress and anxiety, along with improvements in quality of life for participants. This suggests that app-based treatments like the IONA Mind app could also be beneficial for cancer survivors experiencing depression.12345

What safety data exists for the IONA Mind app for depression in cancer survivors?

The provided research does not specifically mention safety data for the IONA Mind app or its related names. The studies focus on various internet-delivered and app-based interventions for mental health in cancer survivors, but none explicitly address the safety data for the IONA Mind app.12456

Is the IONA Mind app a promising treatment for depression in cancer survivors?

Yes, the IONA Mind app is a promising treatment because it can help cancer survivors access mental health support easily through their phones, which is important since many face barriers to in-person care. Mobile apps like this can reach more people and provide support for mental health issues.12467

What is the purpose of this trial?

The goal of this clinical trial is to adapt a mental health digital app to treat depression among head and neck cancer patients and survivors.Participants will download and use the digital mental health app for a 6-week period, and will complete related surveys.

Research Team

EW

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

I am 22 years old or older.
My head or neck cancer diagnosis is confirmed and documented.
Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 and ≤ 19 (moderate and severely moderate depression)
See 1 more

Exclusion Criteria

I am taking prescription medication for depression.
Patient Health Questionnaire-9 (PHQ-9) score of greater than or equal to 20 (severe depression)
Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 1 on the suicidal question (question 9)
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the IONA Mind app for mental health support for a 6-week period

6 weeks
Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 1- and 3-months post-intervention

3 months
2 visits (virtual)

Treatment Details

Interventions

  • IONA Mind app
Trial Overview 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.
Participant Groups
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.

IONA Mind app is already approved in United Kingdom, United States for the following indications:

🇬🇧
Approved in United Kingdom as Iona Mind for:
  • Mental health support for chronic diseases
  • Depression among head and neck cancer patients and survivors
🇺🇸
Approved in United States as Iona Mind for:
  • Mental health support for chronic diseases
  • Depression among head and neck cancer patients and survivors

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The Finding My Way (FMW) online intervention for cancer survivors showed significant improvements in emotional functioning at 3 months and reduced health service utilization immediately after the intervention, indicating potential short-term benefits for participants.
However, while both the FMW and control groups experienced reductions in cancer-related distress, there were no significant differences between the groups over time, suggesting that the FMW intervention may not provide long-term advantages beyond its active use.
Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.Beatty, L., Kemp, E., Coll, JR., et al.[2020]
A review of 19 studies on app-based psycho-oncological interventions for cancer survivors highlights that these apps often include features like psychoeducation, symptom self-monitoring, and relaxation exercises, which are designed to address various psychological challenges faced by patients.
These apps not only provide valuable information but also promote patient empowerment and involvement in their own care, making them a beneficial complement to traditional cancer treatment.
Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review.Springer, F., Mehnert-Theuerkauf, A.[2022]
The Stress Proffen app-based intervention for cancer survivors showed significant reductions in stress, anxiety, and self-regulatory fatigue, along with improvements in health-related quality of life, based on a pilot study with 25 participants.
Participants found the app to be a valuable and accessible tool for stress management, with 67% completing at least 7 out of 10 modules, indicating good engagement and usability.
Pilot testing an app-based stress management intervention for cancer survivors.Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

References

Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors. [2020]
Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review. [2022]
Pilot testing an app-based stress management intervention for cancer survivors. [2022]
A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study. [2020]
Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). [2020]
Assessing an Internet-Delivered, Emotion-Focused Intervention Compared With a Healthy Lifestyle Active Control Intervention in Improving Mental Health in Cancer Survivors: Protocol for a Randomized Controlled Trial. [2022]
Mobile Apps for Mental Health Issues: Meta-Review of Meta-Analyses. [2021]
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