Mental Health App for Depression in Cancer Survivors

(MACS Trial)

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Antidepressants

Disqualifiers: Severe depression, Suicidal, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mental health app designed to assist head and neck cancer survivors dealing with depression. Participants will use the IONA Mind app for six weeks and provide feedback through surveys. It suits individuals with a history of head and neck cancer who experience moderate depression. Those managing this type of depression without medication may find this trial an opportunity to explore a new method for improvement. As an unphased trial, it offers a unique chance to explore innovative mental health support tailored to participants' needs.

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 prior data suggests that this mental health app is safe for cancer survivors?

Research has shown that app-based treatments like the IONA Mind app are generally easy to use. Built on proven methods, the app follows best practices in healthcare. These often include low-intensity cognitive-behavioral therapy (CBT), commonly used to address mental health issues.

While specific safety data for the IONA Mind app is not available, digital mental health tools are typically safe and lack the side effects associated with medications. The app offers personalized mental health support, adjusting to individual needs, which can enhance user comfort.

In summary, based on its design and purpose, the IONA Mind app appears to be a safe option for helping cancer survivors manage depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IONA Mind app because it offers a digital approach to managing depression specifically in cancer survivors, a group that faces unique challenges. Unlike traditional therapies such as medication or in-person counseling, this app provides a convenient and accessible option that users can engage with anytime and anywhere, fitting seamlessly into their daily lives. The IONA Mind app is designed to deliver personalized mental health support through interactive tools and techniques, potentially offering quicker and more tailored relief for depression symptoms. This innovative method of delivery may reduce barriers to mental health care and improve the overall well-being of cancer survivors.

What evidence suggests that the IONA Mind app is effective for treating depression in cancer survivors?

Research has shown that the IONA Mind app, used by participants in this trial, employs methods from cognitive behavioral therapy (CBT) to offer personalized mental health support. CBT is a well-known treatment for depression, helping individuals change negative thought patterns. The app provides low-intensity CBT programs to manage common mental health issues and improve overall well-being. Although limited data exists on the app’s effectiveness for depression in cancer survivors, its use of proven CBT techniques suggests potential benefits. Early findings indicate that digital mental health apps can help users manage depression symptoms and improve mental health. ^{1 2 4 5 6}

Who Is on the Research Team?

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 and ≤ 19 (moderate and severely moderate depression)

My head or neck cancer diagnosis is confirmed and documented.

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)

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: IONA Mind app Experimental Treatment 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Mental health apps, particularly those targeting anxiety and depression, show moderate to high quality evidence of effectiveness, with small to medium effect sizes, indicating they can be beneficial for self-management or as adjunctive treatments.

While stand-alone apps demonstrated better empirical quality, studies with follow-ups indicated that the positive impacts of these apps can be sustained for at least 11 weeks, highlighting their potential for long-term support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for Mental Health Issues: Meta-Review of Meta-Analyses. Lecomte, T., Potvin, S., Corbière, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 iCanThrive app, combined with phone coaching, significantly reduced symptoms of depression and sleep disruption among 28 survivors of women's cancer over a 6-week period, indicating its potential efficacy as a mental health intervention.

With an 87% completion rate and positive user feedback, the app shows promise for scalability and accessibility in addressing the mental health needs of cancer survivors, warranting further validation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study. Chow, PI., Drago, F., Kennedy, EM., et al.[2020]

The CanCope Mind (CM) intervention is a web-based program designed to improve emotion regulation and mental health in cancer survivors, and it is being compared to a healthy lifestyle intervention (CanCope Lifestyle) in a randomized controlled trial with 224 participants.

This study is significant as it is one of the first to specifically target emotion regulation in cancer survivors through an internet-delivered format, with assessments planned at multiple time points to evaluate its efficacy in reducing anxiety and depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Smith, IS., Wallace, R., Wellecke, C., et al.[2022]

In a study of 114 cancer survivors, internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of anxiety and depression compared to treatment-as-usual, with a large effect size (Hedges g = 1.51).

Participants in the iCBT group also experienced lower general distress, reduced fear of cancer recurrence, and improved quality of life, indicating that this therapy is an effective and efficient option for managing mental health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Murphy, MJ., Newby, JM., Butow, P., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-head-and-neck-carcinoma-8-2024-3dc00

Mental Health App for Depression in Cancer Survivors ... Trial Overview The IONA Mind app, a digital mental health application, is being tested for its effectiveness in treating depression among patients and survivors ...

2. app.trialscreen.org app.trialscreen.org/trials/mental-health-app-cancer-survivors-trial-nct06472726

Mental Health App for Cancer Survivors Study Participants may benefit from receiving personalized mental health support and guidance through the adapted IONA Mind app, which could potentially help manage ...

3. careacross.com careacross.com/clinical-trials/trial/NCT06472726

Mental Health App for Cancer Survivors Study Summary: 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.

4. ionamind.com ionamind.com/solutions-tailored-support

Tailored psychological support for your population Iona Mind uses evidence-based techniques from CBT in order to provide effective, personalized mental health support to your workforce.

5. aptar.com aptar.com/news-events/aptar-digital-health-iona-mind-to-deliver-mental-health-support/

Aptar Digital Health and Iona Mind Partner to Deliver ... The Iona Mind platform contains low-intensity CBT programs for managing common mental health conditions and general wellbeing.

6. ionamind.com ionamind.com/our-approach

Our Approach — Iona Mind - Tailored Mental Health ... Iona Mind has developed an evidence informed framework for developing app-based psychological wellbeing tools based upon clinical best practice.