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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

Primary Purpose

Depression, Depressive Symptoms, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy app
Treatment as Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936 ILLIC (as determined during manual chart review) age 18+ currently own an iOS- or Android-compatible smartphone report 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 fluency Exclusion Criteria: Severe cognitive impairment that precludes completion of informed consent current suicidal ideation on the PHQ-9 at screening or final study eligibility, defined as a response ≥1 (several days) on item nine

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Treatment as Usual

Moodivate

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2023
Last Updated
September 26, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05932810
Brief Title
Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer
Official Title
Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Symptoms, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Other
Arm 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.
Arm Title
Moodivate
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accrual
Description
The proportion of Illic eligible for the trial who accrue to the study.
Time Frame
Study duration (6-7 months or until recruitment is reached)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elevated depressive symptoms, defined as a score of ≥ 10 on the PHQ-936 ILLIC (as determined during manual chart review) age 18+ currently own an iOS- or Android-compatible smartphone report 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 fluency Exclusion Criteria: Severe cognitive impairment that precludes completion of informed consent current suicidal ideation on the PHQ-9 at screening or final study eligibility, defined as a response ≥1 (several days) on item nine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Dahne, PhD
Phone
843-876-2280
Email
dahne@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Dahne, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Dahne, PhD
Phone
843-876-2280
Email
dahne@musc.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Dahne, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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