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

Not Applicable

Completed

• Conditions: Depressive Symptoms; Depression; Cancer

• Registration Number: NCT05932810
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-05
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Primary Completion: 2024-06-04
• Study Completion: 2024-07-02
• Status Verified: 2025-03
• Results First Submitted: 2025-03-13
• Results First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Results First Posted: 2025-04-01
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936
2. ILLIC (as determined during manual chart review)
3. age 18+
4. currently own an iOS- or Android-compatible smartphone
5. report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
6. have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)
7. English fluency

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accrual	Study duration (6-7 months or until recruitment is reached)	The proportion of Illic eligible for the trial who accrue to the study.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States