IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT06582784
- Status
- Recruiting
Conditions
- Cancer
- Depression
- Depressive Symptoms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Activation Therapy App — BEHAVIORALMoodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
- Treatment as Usual — BEHAVIORALParticipants 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 week 12.
Study Details
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.
Key Dates
- Start date
- Oct 28, 2024
- Status verified
- May 2026
- Primary completion
- Sep 1, 2028
- Completion
- Sep 1, 2028
Study Design
- Enrollment
- 279 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Treatment as UsualParticipants 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.
- Experimental: MoodivateParticipants 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.
Primary Outcome Measure
Change in Depression [ Time Frame: 12 weeks ]
Central Contacts
- Jennifer Dahne, Ph.D.843-876-2280
- Noelle Natale843-876-9457
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 |
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