IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
Recruiting · NCT06582784 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age \> 18 years
- ILLIC (as determined during manual chart review)
- Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9
- Current owner of an iOS- or Android-compatible smartphone
- Willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
- Have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
- English language fluency
Exclusion criteria
- Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9
- Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:
- Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or
- Self-report of cognitive difficulties that impair functional independence
Where it is running
1 location listed across 1 US state.
- Medical University of South Carolina - Charleston, South Carolina, United States