Recruiting

Moodivate & Telehealth

Sponsor:

Medical University of South Carolina

Code:

NCT06930729

Conditions

Cancer

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Activation Therapy App

Telehealth Delivered Behavioral Activation

Study Details

Brief summary:

The purpose of this research study is to evaluate different depression treatment approaches among cancer survivors. A cancer survivor is defined as anyone who is living and has been diagnosed with cancer.

Participants will be randomly assigned to either receive a mobile app for depression treatment, called "Moodivate", or to receive telehealth depression treatment sessions. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will receive depression treatment via telehealth. Participants that receive Moodivate may later be assigned to also receive depression treatment via telehealth based their response to the Moodivate app. Participants will be asked to either use the Moodivate app and/or receive depression treatment via telehealth for a period of 10 weeks.

All participants will be asked to electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as general experiences using Moodivate and participating in this trial. Participation in this study will take about 24 weeks.

Participation in this study may help improve options for emotional wellness for cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality.

Conditions

Cancer

Depression

Study ID

NCT06930729

Start date

Aug 12, 2025

Status verified date

Jul, 2026

Completion date

Sep 21, 2026

Anticipated

Primary completion date

Sep 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 18+
  • cancer survivor
  • current elevated depressive symptoms defined per ASCO as a PHQ-9 score ≥ 8
  • not currently receiving psychosocial depression treatment
  • have the ability to complete treatment via telehealth and use Moodivate
  • have a valid e-mail address or text message access (for assessments)
  • English fluency

Exclusion Criteria:

\- Current suicidal ideation at final eligibility screening (PHQ-9 item 9 ≥1)

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Digitally-Enhanced Stepped Care

Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Digitally-Enhanced Stepped Care 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 at weeks 12, 16, 20, and 24 post-randomization. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.

active comparator: Guideline-Concordant Standard Care

Participants randomized to the Guideline-Concordant Standard Care condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization.

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 at weeks 12, 16, 20, and 24 post-randomization.

Telehealth Delivered Behavioral Activation

8 sessions of telehealth-delivered Behavioral Activation with a mental health provider over a 10-week period.

Primary outcome measure

  • Feasibility of a digitally-enhanced stepped care approach to depression treatment among cancer survivors. [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Olivia Levins

843-792-3681levins@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Olivia Levins

843-792-3681levins@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 14, 2026

Last verified

Jul, 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 2026-07-14.