Recruiting

Cancer Survivors' Mental Health

Sponsor:

Medical University of South Carolina

Code:

NCT06582784

Conditions

Depression

Depressive Symptoms

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Activation Therapy App

Treatment as Usual

Study Details

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 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.

Conditions

Depression

Depressive Symptoms

Cancer

Study ID

NCT06582784

Start date

Oct 28, 2024

Status verified date

May, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

279 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment as Usual

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 8 weeks with a final follow up at 12 weeks.

experimental: Moodivate

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 8 weeks with a final follow up at week 12.

Interventions

Behavioral 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.

Treatment 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.

Primary outcome measure

  • Change in Depression [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Jennifer Dahne, Ph.D.

843-876-2280dahne@musc.edu

Noelle Natale

843-876-9457natalen@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Jennifer Dahne, PhD

843-876-2280dahne@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-22.