RecruitingNot ApplicableNCT06582784

IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)

Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Likely Incurable Cancer


Sponsor

Medical University of South Carolina

Enrollment

279 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a mobile phone app can help cancer survivors manage depression more proactively, by connecting them to mental health support before their symptoms become severe. The app is designed to be used between medical visits as a practical mental health tool. **You may be eligible if...** - You are a cancer survivor aged 18 or older - You are experiencing elevated depression symptoms (score of 8 or higher on the PHQ-9 questionnaire) - You own a smartphone (iPhone or Android) - You are willing to use an app to help manage your mood - You have a valid email address you check regularly **You may NOT be eligible if...** - You are currently receiving psychiatric treatment for depression - You have active suicidal intent - You do not have reliable access to a smartphone or internet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBehavioral Activation Therapy App

Moodivate 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.

BEHAVIORALTreatment as Usual

Participants 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.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06582784


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