Moodivate App for Depression in Cancer Survivors

(IMPACT Trial)

Overseen By Jennifer Dahne, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Suicidal ideation, Dementia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

279 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called "Moodivate" to help cancer survivors manage symptoms of depression. Participants will either use the app or receive standard educational material for mood management. To evaluate Moodivate's effectiveness, participants will complete surveys about their mood and experience during the 12-week study. Cancer survivors with a smartphone who have been feeling down or depressed may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mood management for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for depression treatment, so you may not need to change your current medication routine.

What prior data suggests that the Moodivate app is safe for cancer survivors?

Research has shown that the Moodivate app is generally safe for users. In earlier studies, users reported that the app was easy to use and helpful. Some studies have found that Moodivate can significantly improve depression symptoms compared to regular care.

While no serious side effects have been reported, using the app might cause some frustration or emotional upset. These risks are not unique to Moodivate and can occur with any depression treatment. The main concerns involve potential data breaches or loss of privacy, which can happen with any digital app, not just Moodivate.

In summary, current research considers Moodivate to be generally well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Moodivate app is unique because it leverages digital technology to help cancer survivors manage depression directly through their smartphones. Unlike traditional treatments that may include medications or therapy sessions, Moodivate empowers users to actively engage in mood management by identifying personal values, planning activities, and tracking their mood daily. This app-based approach offers a new level of accessibility and personalization, allowing users to integrate mental health management into their daily lives seamlessly. Researchers are excited about Moodivate's potential to provide a convenient, self-guided tool that could complement existing treatments and offer support outside of clinical settings.

What evidence suggests that the Moodivate app might be an effective treatment for depression in cancer survivors?

Research has shown that the Moodivate app can greatly reduce depression symptoms. In this trial, participants using the Moodivate app reported twice as much improvement compared to those receiving standard treatment. The app functions like a "therapist in your pocket," helping users track their mood and engage in activities that improve their well-being. Although specific data for cancer survivors is limited, the app's success in reducing depression suggests it could benefit this group as well. Early results are encouraging, indicating that Moodivate may help cancer survivors manage their depression effectively. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for cancer survivors over 18 with depression, fluent in English, who own a smartphone and are willing to use an app for mood treatment. They must have noticeable depressive symptoms (score ≥ 8 on the PHQ-9) and check their email or texts regularly.

Inclusion Criteria

I am older than 18 years.

I am willing to use a mobile app for depression treatment.

I regularly check my email or can receive text messages for follow-ups.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either download the mobile app 'Moodivate' or not, and complete weekly questionnaire measures for 8 weeks

8 weeks

Weekly electronic questionnaires

Follow-up

Participants complete a final follow-up questionnaire at 12 weeks to assess changes in depression, quality of life, and anxiety symptoms

4 weeks

1 final electronic questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• Moodivate

Trial Overview

The study tests 'Moodivate', a mobile app designed to help with depression among cancer survivors. Participants will either use the app or continue with usual care without it, randomly assigned in a ratio of about two-thirds to one-third respectively.

How Is the Trial Designed?

Group I: Treatment as Usual Experimental Treatment 1 Intervention

Participants in the treatment as usual group will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their oncology provider. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at 12 weeks.

Group II: Moodivate Experimental Treatment 1 Intervention

Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 8 weeks with a final follow up at week 12.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

mHealth applications have shown promise in improving pain and fatigue outcomes for cancer survivors, with three out of four studies reporting positive results for pain and four studies indicating improvements in fatigue.

While there is some evidence for benefits in psychological distress and sleep outcomes, the results were mixed, highlighting the need for further development and targeted approaches in mHealth interventions for cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. Hernandez Silva, E., Lawler, S., Langbecker, D.[2020]

CanDirect, a telephone-delivered self-care intervention, significantly reduced depressive symptoms in cancer survivors compared to usual care, with an effect size of 0.61 after 6 months.

Participants in the CanDirect group also experienced improved quality of life, lower anxiety, and reduced rates of depression diagnoses, although the intervention was less effective in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CanDirect: Effectiveness of a Telephone-Supported Depression Self-Care Intervention for Cancer Survivors. McCusker, J., Jones, JM., Li, M., et al.[2021]

The AWAKE program, an 8-week app-based intervention for young adult cancer survivors, showed high retention and satisfaction rates, with participants finding the content relevant and beneficial for discussing their experiences positively.

While the study involved a small sample size (n=38 for AWAKE and n=18 for attention control), there were positive trends in hope and quality of life outcomes, suggesting that hope-based interventions could help young adults reorient their goals after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hope-Based Intervention to Address Disrupted Goal Pursuits and Quality of Life Among Young Adult Cancer Survivors. Berg, CJ., Vanderpool, RC., Getachew, B., et al.[2021]

A study involving 27 participants, including cancer patients/survivors and healthcare providers, aimed to develop a mobile meditation app tailored specifically for cancer patients, highlighting the need for cancer-specific content and functionality.

Participants expressed a strong preference for app features that address cancer-related emotions and experiences, such as anxiety and fear of recurrence, as well as a desire for community support and symptom-specific resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging a Consumer-Based Product to Develop a Cancer-Specific Mobile Meditation App: Prototype Development Study. Huberty, J., Bhuiyan, N., Neher, T., et al.[2022]

The Untire mHealth app significantly improved fatigue severity and quality of life in cancer patients and survivors, with 519 participants in the intervention group showing better outcomes compared to 280 in the control group over 12 weeks.

Participants who used the app more frequently experienced the greatest benefits, indicating that higher engagement with the app correlates with improved management of cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beating cancer-related fatigue with the Untire mobile app: Results from a waiting-list randomized controlled trial. Spahrkäs, SS., Looijmans, A., Sanderman, R., et al.[2021]

A pilot study involving 35 cancer patients showed that a smartphone-based meditation app is feasible and acceptable, with a 61% enrollment rate and 71% adherence over two weeks.

Participants using the app reported significant improvements in anxiety, fatigue, and overall distress, particularly with longer meditation sessions (15 minutes), suggesting the app could be a beneficial tool for managing mood symptoms in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. Lopez, G., Chaoul, A., Warneke, CL., et al.[2023]

A systematic review of 11 randomized trials involving 2249 breast cancer survivors found that psychological mobile health interventions, primarily based on cognitive behavioral therapy, showed limited effectiveness in improving mental health outcomes, with only a few studies reporting significant short-term benefits for psychological distress.

Despite some short-term improvements in specific areas like distress and anxiety, there was no evidence of long-term benefits beyond three months, and a notable percentage of participants either did not start or discontinued the interventions, highlighting the need for better-designed studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. Horn, A., Jírů-Hillmann, S., Widmann, J., et al.[2023]

A self-management mobile application for colorectal cancer survivors significantly improved self-efficacy, health practices, and quality of life after six weeks of use, as shown by surveys of 39 participants.

The intervention led to specific improvements in emotional functioning and reductions in overall symptoms and fatigue, highlighting the effectiveness of mobile technology in providing social support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive coaching intervention on quality of life and psychological factors for colorectal cancer survivors: A single group pre and posttest design. Yoon, J., Lee, H., Son, H.[2023]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06582784

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The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors.

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adaa.trialstoday.org

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Anxiety & Depression Association of America

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors.

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connect.careboxhealth.com/en-US/trial/listing/592836

Optimizing Care for Cancer Survivors With Depression: Project 3

Participants that receive Moodivate may later be assigned to also receive depression treatment via telehealth based their response to the Moodivate app.

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web.musc.edu/about/news-center/2025/04/14/mood-improving-app

Having a “therapist in your pocket” curbs depression ...

Patients with depression who received the Moodivate app saw clinically meaningful reductions in their symptoms that were twice those achieved with standard-of- ...

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withpower.com

withpower.com/trial/phase-depression-10-2024-eb2cb

Moodivate App for Depression in Cancer Survivors

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5592783/

Moodivate: A self-help behavioral activation mobile app for ...

We discuss the development of a BATD mobile application, Moodivate, that was developed in order to disseminate BATD via primary care.

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cdn.clinicaltrials.gov/large-docs/14/NCT04463914/Prot_SAP_001.pdf

Version Date 11/6/2023 Page 1 of 28

Results of our Phase I study indicate that Moodivate is feasible and acceptable to primary care patients and that use of the app relative to TAU is associated ...

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withpower.com

withpower.com/trial/phase-depression-4-2025-1e657

Behavioral Activation Therapy for Cancer Survivors with ...

This N/A medical study run by Medical University of South Carolina is evaluating whether Moodivate will have tolerable side effects & efficacy for patients ...