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

Trial Summary

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 data supports the effectiveness of the treatment Moodivate for depression in cancer survivors?

Research shows that mobile health (mHealth) apps can help cancer survivors manage psychological distress, including depression. For example, the CanDirect study found that a telephone-supported self-care intervention improved depression in cancer survivors, suggesting that similar app-based treatments like Moodivate could be effective. ^{1 2 3 4 5}

How is the Moodivate app treatment different from other treatments for depression in cancer survivors?

The Moodivate app is unique because it is a mobile application specifically designed to help cancer survivors manage depression by focusing on mood and activity tracking, which is not commonly found in traditional treatments. It offers a convenient, accessible way for users to engage with their mental health care through their smartphones. ^{3 4 6 7 8}

What is the purpose of this trial?

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood. Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not. All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today. Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States 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. [2020]

2. Scotland 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

CanDirect: Effectiveness of a Telephone-Supported Depression Self-Care Intervention for Cancer Survivors. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A Hope-Based Intervention to Address Disrupted Goal Pursuits and Quality of Life Among Young Adult Cancer Survivors. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Beating cancer-related fatigue with the Untire mobile app: Results from a waiting-list randomized controlled trial. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Leveraging a Consumer-Based Product to Develop a Cancer-Specific Mobile Meditation App: Prototype Development Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. [2023]