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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932810
• Other study ID #: 00126828
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: July 5, 2024

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Jennifer Dahne, PhD
• Phone: 843-876-2280
• Email: dahne[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 5, 2024
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• 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 4 weeks following study enrollment.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual	The proportion of Illic eligible for the trial who accrue to the study.	Study duration (6-7 months or until recruitment is reached)