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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
Interventions
Behavioral: Treatment as Usual
Behavioral: Behavioral Activation Therapy app
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

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
Arm && Interventions
GroupInterventionDescription
Treatment as UsualTreatment as UsualParticipants 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.
MoodivateBehavioral Activation Therapy appParticipants 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.
Primary Outcome Measures
NameTimeMethod
AccrualStudy duration (6-7 months or until recruitment is reached)

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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