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

NCT05932810 | Completed Results

• 1 other identifier: 00126828
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Symptoms; Cancer

Outcome Measures

Primary Outcomes (1)

• Accrual

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

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

Study Arms (2)

Treatment as Usual

OTHER

Participants in the treatment as usual group 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 4 weeks following study enrollment.

Behavioral: Treatment as Usual

Moodivate

EXPERIMENTAL

Participants randomized to the Moodivate condition will be instructed to utilize Moodivate regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Moodivate group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.

Behavioral: Behavioral Activation Therapy app

Interventions

Behavioral Activation Therapy app BEHAVIORAL

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.

Moodivate

Treatment as Usual BEHAVIORAL

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 4 weeks following study enrollment.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936
• ILLIC (as determined during manual chart review)
• age 18+
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Graboyes EM, Levins O, DeMass R, Baskar N, Natale N, Sterba KR, Obeid JS, Sharma S, Hill EG, Dahne J. Proactive Identification and Digital Mental Health Intervention for the Treatment of Depression Among Individuals With Likely Incurable Cancer: A Pilot Randomized Clinical Trial. Psychooncology. 2025 Oct;34(10):e70309. doi: 10.1002/pon.70309.

  PMID: 41125447 DERIVED

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jennifer Dahne
• Organization: Medical University of South Carolina

dahne@musc.edu

843-876-2280

Study Officials

• Jennifer Dahne, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 6, 2023
• Study Start: May 5, 2023
• Primary Completion: June 4, 2024
• Study Completion: July 2, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)