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 Carolina (MUSC)

Status: Completed

Conditions: Depressive Symptoms; Cancer; Depression

Treatments: Behavioral: Behavioral Activation Therapy app; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05932810

00126828

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment as Usual

Other group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Moodivate

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation Therapy app