Cancer, Depression, Depressive Symptoms
Conditions
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALTreatment 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual | Study duration (6-7 months or until recruitment is reached) | The proportion of Illic eligible for the trial who accrue to the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | Treatment as Usual | Moodivate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 14 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 15 Participants | 23 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 10 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 20 |
| other Total, other adverse events | 0 / 10 | 0 / 20 |
| serious Total, serious adverse events | 0 / 10 | 0 / 20 |
Outcome results
Primary
Accrual
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | Accrual | 10 Participants |
| Moodivate | Accrual | 20 Participants |