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

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Cancer Depression Depressive Symptoms

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

Inclusion Criteria7

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 Criteria4

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

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.