Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Other | 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. |
|
| Moodivate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation Therapy app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accrual | The proportion of Illic eligible for the trial who accrue to the study. | Study duration (6-7 months or until recruitment is reached) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Dahne, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41125447 | Derived | Graboyes EM, Levins O, DeMass R, Baskar N, Natale N, Sterba KR, Obeid JS, Sharma S, Hill EG, Dahne J. Proactive Identification and Digital Mental Health Intervention for the Treatment of Depression Among Individuals With Likely Incurable Cancer: A Pilot Randomized Clinical Trial. Psychooncology. 2025 Oct;34(10):e70309. doi: 10.1002/pon.70309. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Treatment as Usual | Behavioral | 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. |
|
| FG001 | Moodivate | 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. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | 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 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. |
| BG001 | Moodivate | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accrual | The proportion of Illic eligible for the trial who accrue to the study. | Posted | Count of Participants | Participants | Study duration (6-7 months or until recruitment is reached) |
|
|
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual | 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 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Moodivate | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Dahne | Medical University of South Carolina | 843-876-2280 | dahne@musc.edu |
| Jun 16, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|