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Clinical Trials/NCT05932810
NCT05932810
Completed
Not Applicable

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

Medical University of South Carolina1 site in 1 country30 target enrollmentMay 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Medical University of South Carolina
Enrollment
30
Locations
1
Primary Endpoint
Accrual
Status
Completed
Last Updated
last year

Overview

Brief 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 the investigators 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 the participant's experiences using Moodivate and participating in this trial. Participation in this study will take about 4 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 the participant contacting their primary care provider or their oncology care team to discuss other available treatments for depressed mood.

Registry
clinicaltrials.gov
Start Date
May 5, 2023
End Date
July 2, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Dahne

Associate Professor

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936
  • ILLIC (as determined during manual chart review)
  • currently own an iOS- or Android-compatible smartphone
  • report 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 fluency

Exclusion Criteria

  • Severe cognitive impairment that precludes completion of informed consent
  • current suicidal ideation on the PHQ-9 at screening or final study eligibility, defined as a response ≥1 (several days) on item nine

Outcomes

Primary Outcomes

Accrual

Time Frame: Study duration (6-7 months or until recruitment is reached)

The proportion of Illic eligible for the trial who accrue to the study.

Study Sites (1)

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