Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer
Phase: NA
Conditions: Depression, Depressive Symptoms, Cancer
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: Evaluation of a Proactive Identification and Digital Mental Health 
Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living with Cancer 
 
PRINCIPAL INVESTIGATOR: Jennifer Dahne, Ph.D. 
 
 
 

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1.0 
Objectives 
Primary: To evaluate the feasibility of conducting a randomized clinical trial (RCT) comparing a proactive 
identification + digital mental health intervention (DMHI) approach vs treatment as usual (TAU) among 
individuals living with likely incurable cancer (ILLIC) with depression. 
 
Secondary: To determine the acceptability, appropriateness, and adoption of a proactive identification + 
DMHI approach and TAU among ILLIC with depression. 
 
Secondary: To examine the fidelity of Moodivate approach among ILLIC with depression. 
 
Exploratory: To explore the effect of a proactive + DMHI approach on depression, anxiety, and quality of 
life among ILLIC with depression relative to TAU. 
 
2.0 
Background 
ILLIC are a heterogeneous, growing subpopulation of cancer survivors who have unique 
survivorship care needs1,2. Principal among these is the need for psychosocial treatment3. Treatment of 
depression is particularly critical as up to half of ILLIC report depressive symptoms4-7. Negative sequalae 
of depression include lower quality of life8, reduced adherence to anti-cancer therapies9, suicidal ideation10, 
and desire for hastened death10-12. Numerous trials13-16 and meta-analyses6,17 have documented that 
evidence-based psychosocial treatment improves depression outcomes for ILLIC. However, multilevel 
barriers, including transportation issues, stigma, 
and a scarcity of oncology mental health 
providers18-20 limit treatment access (Figure 1). 
Thus, ILLIC need feasible, accessible evidence-
based depression treatment options.  
 
Best practice guidelines for comprehensive 
survivorship care suggest that screening and 
assessment of psychosocial concerns should be 
part of every clinical encounter11,12,21. Short 
depression screeners (e.g., the PHQ-222) are now 
routinely administered in oncology settings21,23 and 
these data can be used to proactively (i.e., outside 
of a clinical encounter) identify survivors in need 
of psychosocial treatment and link them to scalable options. While psychosocial screening data are recorded 
in structured Electronic Health Record (EHR) fields and can be readily used for proactive identification of 
patients with depression, efficient identification of ILLIC is more challenging. Data necessary to determine 
likelihood of curability, such as advanced stage at diagnosis or progression to metastatic cancer, are 
typically recorded in unstructured EHR fields24, necessitating labor-intensive, manual chart review to 
identify ILLIC. To realize the goal of proactive identification and delivery of scalable evidence-based 
depression care for ILLIC, accurate, efficient, automated identification approaches are needed. 
Self-guided digital mental health interventions (DMHIs) can be paired with proactive identification 
to deliver scalable evidence-based depression treatment25. Our team previously adapted one evidence-based 
depression treatment26-29, Behavioral Activation (BA), for delivery via a DMHI called “Moodivate.” Of 
available psychosocial depression treatments, BA is an ideal fit for ILLIC because of its: 1) strong clinical 
evidence base among cancer survivors26-29 and 2) appropriateness for an underlying mechanism of 
depression faced by ILLIC. Our pilot work among primary care patients with depression demonstrated that 
Moodivate is a feasible, acceptable, and efficacious DMHI30,31. While a proactive treatment delivery model 
using a DMHI such as Moodivate may be a promising approach to deliver evidence-based depression 
treatment to ILLIC, additional work is needed to determine feasibility and efficacy of the approach.  
 
Organization
Provider
Cancer 
Survivor
Multilevel Proactive DMHI
• Creates a clear referral pathway
• Eliminates the need to increase 
parking availability to accommodate 
additional treatment services
• Overcome time constraints
• Limit the need for additional 
education in psychosocial treatment
• Provides a concrete resource to 
provide to patients
• Address limited access to providers
• Reduce travel distances
• Intervention can be utilized privately,
reducing stigma
Figure 1: Conceptual Model 

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3.0 
Intervention to be studied  
Moodivate: When users first download Moodivate, they complete a psychoeducational interactive tutorial, 
practice generating goals and activities, and receive instruction on app use. Users are then taken to their 
Home screen where they can see an overview of their activities for the day, plan additional activities, and 
track mood. Users are prompted to continuously generate new goals across life areas (Relationships, Daily 
Responsibilities, Recreation, Career and Education, Health) and multiple activities within each goal. By 
being connected to what the user values, this goal-driven framework ensures that activities will be positively 
reinforced32. Once a user has identified activities across goals, activities are scheduled and monitored via 
the Calendar (for future planning) and Home (for today) screens. After completing an activity, the user 
receives reinforcement (e.g., “Great job!”). Moodivate users can track daily mood to monitor progress and 
are prompted to complete a clinical assessment of depressive symptoms33 once every two weeks. Users can 
view a graph of fluctuations in mood and depressive symptoms overlaid upon a graph of the number of 
completed activities, illustrating the connection between activity and mood. Users are reinforced for 
treatment engagement via badges31. Users are encouraged to use the app regularly, at least once per day, 
for the treatment of depressed mood34. If randomized to receive Moodivate, study staff will provide the 
participant with a Moodivate app download code and will ensure successful download. Study staff will then 
give the participant a brief, scripted overview (as utilized in our R41 and R42) regarding app utilization and 
will provide the participant with 10 minutes to use the app and ask questions. 
 
 
 
 
TAU: TAU mimics existing depression treatment for ILLIC. Participants in both conditions will be 
provided educational mood management material available via the EHR with the suggestion to discuss 
questions with their oncology provider. Across conditions, participants will not be precluded from obtaining 
additional treatment (e.g., pharmacotherapy, palliative care), which will be tracked throughout the study via 
self-report. 
 
 
 
4.0 
Study Endpoints 
Table 1. Study Objectives and Endpoints 
OBJECTIVES 
ENDPOINTS 
Primary: To evaluate the feasibility of 
conducting a RCT comparing a proactive 
identification + DMHI approach vs TAU 
among ILLIC with depression 
ILLIC case identification 
Accrual 
Retention 
Secondary: To determine the acceptability, 
appropriateness, and adoption of a proactive 
identification + DMHI approach among 
ILLIC with depression. 
System Usability Scale (SUS)35 score 
Number of Moodivate app sessions 
Average time per Moodivate session 
Total time using the Moodivate app 
Number of goals created within Moodivate 
Figure 2: Moodivate 

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Table 1. Study Objectives and Endpoints 
OBJECTIVES 
ENDPOINTS 
Number of activities created within Moodivate 
Number of activities scheduled within Moodivate 
Number of activities completed  
Exploratory: To explore the effect of a 
proactive + DMHI approach on depression, 
anxiety, and quality of life among ILLIC with 
depression relative to TAU. 
Change in the PHQ-936 score from baseline to 1-month 
follow-up. 
Change in the Hospital Anxiety and Depression Scale, 
Anxiety subscale (HADS-A) score from baseline to 1-
month follow-up. 
Change in the Functional Assessment of Cancer 
Therapy-General (FACT-G7) score from baseline to 1-
month follow-up. 
 
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
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  
 
6.0 
Number of Subjects 
We will recruit 15 participants to examine the feasibility, acceptability, and preliminary efficacy of 
proactive identification + DMHI vs TAU among ILLIC with depression. 
 
7.0 
Setting 
This study will be conducted within the NCI-Designated Hollings Cancer Center (HCC) and recruitment 
will leverage the HCC Survivorship and Cancer Outcomes Research (SCOR) infrastructure (Director: 
mPI Graboyes). As the only NCI-Designated Cancer Center in SC, HCC serves a diverse racial, 
socioeconomic, and geographic population. More than 3,500 new patients are diagnosed or treated at 
HCC annually. 
 
8.0 
Recruitment Methods 
Study participants will be recruited proactively and remotely via the EHR using the same procedures 
utilized in our team’s prior proactive behavioral health intervention trials. We will utilize available EHR 
data via a research data request to obtain a recruitment report of HCC patients with depressive symptoms 
with likely incurable cancer. Free-text and other fields (e.g., radiology reports, lab values) will be manually 
reviewed to identify survivors with likely incurable cancer. Discrete fields (e.g., PHQ-2 screening, 
depression-related diagnostic or billing codes) will be used to identify those with likely depressive 

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symptoms. Herein, we define ILLIC as persons who are diagnosed with advanced cancer that is likely 
incurable or diagnosed with or progressing to metastatic cancer. This definition, which varies by cancer 
type and available treatments and includes a range of survival trajectories, will be defined for each patient 
based on the assessment and plan of the treating oncologist and/or consensus discussion at the multi-
disciplinary tumor board documenting an advanced cancer stage that is deemed likely incurable and/or 
cancer that is metastatic upon diagnosis and/or progresses to metastatic following prior treatments. 
Depression will be defined as 1) a score of > 3 on the last PHQ-2 (the optimal cut-point to identify 
depression37), 2) depression listed on the problem list, or 3) a depression-related billing code associated 
with the last visit. To facilitate chart review, EHR data and clinical notes will be imported into a secure 
REDCap database38. Labels (ILLIC/non-ILLIC) will be provided as fields in REDCap and team members 
will assign an outcome. Clear guidelines will be created based on the ILLIC definition and linked in the 
REDCap project for easy reference. 
Patients on the study recruitment report identified as having likely incurable cancer and depressive 
symptoms will be sent a study invitation by the research team. Invitations will be sent via MyChart, text 
message, e-mail, and/or phone call and we will follow all requirements of the POR process. The study team 
will not cold-contact any patients who have opt-ed out of receiving contact about research or who have met 
the maximum number of contact attempts at the time of recruitment. If interested, participants will complete 
an online screening within REDCap to determine preliminary study eligibility.  
 
9.0 Consent Process 
After completing determination of preliminary eligibility, a member of the research team will schedule a 
phone call with the participant to determine final study eligibility (no suicidal ideation reported on the PHQ-
9 and a score >=10 on the PHQ-9). After determination of final study eligibility, a study team member will 
complete remote electronic informed consent (e-consent) with the participant via REDCap. Participants will 
receive a link to an electronic consent form, available via REDCap, that they can review and sign. Review 
of the consent form will be paired with a phone call with a member of the research team to ensure that all 
questions are answered prior to enrollment. This remote consent procedure is currently utilized across all 
of Dr. Dahne’s current NIH-funded awards. As smartphone ownership is an inclusion criterion (to use 
Moodivate), all participants will have internet access and thus access to the electronic consent form. All 
participants will electronically sign informed consent forms that have been IRB-approved once the study is 
explained to them in full and they have stated that they understand what is being asked of them. Participants 
will be given the opportunity to ask questions about their participation throughout the course of the study. 
A copy of the informed consent will be kept centrally at our study office within locked filing cabinets and 
a copy will also be given to each study participant. Participants will be given a study phone number and e-
mail address to contact for questions. 
 
10.0 Study Design / Methods 
ILLIC with depressive symptoms identified chart review will be randomized 2:1 to proactive identification 
+ DMHI vs TAU via a two-arm remote pilot feasibility RCT (N=15). The purpose of this pilot trial is to 
refine trial methods in preparation for a larger future grant (e.g., R01) and examine the feasibility, 
acceptability, and preliminary efficacy of proactive identification + self-guided DMHI approach vs TAU. 
 
In addition to baseline assessments completed following e-consent, all participants will be text messaged 
and/or emailed a REDCap link, accessible via smartphone, to complete follow-ups weekly for 4 weeks. 
Assessments are estimated at 10 minutes each and participants will be compensated $40 in electronic gift 
codes for completion of baseline assessments, $40 for completion of each follow-up assessment, and $100 
as a bonus if all study assessments are completed. Additionally, participants will be invited to attend a post-
study interview (~30-45 minutes) to help further refine trial procedures. Individual interviews may occur 
either remotely using an MUSC-approved HIPAA compliant video conferencing platform (e.g., Microsoft 
Teams, MUSC Pro Zoom) Those who participate in these interviews will earn an additional $40 (total 

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potential compensation = $340). Procedures for remote remuneration are well-established through our prior 
trials39. 
 
We will collect the following study measures from the EHR or patient self-report as indicated below. 
 
Baseline Demographics (Assessed via self-report at baseline) 
Participants will self-report age, race, sex, ethnicity, marital status, insurance, and home address (which 
will be used to determine rurality).  
 
Clinical characteristics (Assessed via EHR data and self-report at baseline) 
Clinical and mental health characteristics are assessed using clinical documentation within the EHR 
unless otherwise indicated. 
 
We will collect data via the EHR and participant self-report regarding include type of cancer (breast, lung, 
colon, etc), type of ILLIC [locally advanced, metastatic], current cancer treatment (chemotherapy, 
immunotherapy, etc), and ECOG performance status40. We will also collect self-report data regarding use 
of psychotherapy, pharmacotherapy, DMHIs, and supportive care services (e.g., palliative care, support 
groups). 
 
Technological Experience (Assessed via self-report at baseline) 
Pew Research Center’s technology adoption survey: This validated survey will be used to assess experience 
using technology and internet access (home broadband, access via mobile device)41. 
 
Mobile Device Proficiency Questionnaire (MDPQ-16)42: The MDPQ-16 is a validated 16-item measure of 
mobile device proficiency. 
 
Computer Proficiency Questionnaire (CPQ-12)43: The CPQ-12 is a validated 12-item measure of computer 
proficiency. 
 
Implementation (Assessed via self-report Week 4 [SUS] and via app analytics across study duration) 
System Usability Scale (SUS35): The SUS is a 10-item self report measure of acceptability. 
 
Adoption: Adoption will be characterized as 1) number of app sessions, 2) average time per session, and 3) 
total time using the app. 
 
Retention: Retention will be defined as any app use within each week following enrollment. 
 
Fidelity: Fidelity will be measured as 1) number of goals created, 2) number of activities created, 3) number 
of activities scheduled, and 4) number of activities completed. 
 
Clinical Efficacy (Assessed at baseline and at all study timepoints via self-report) 
PHQ-936: The PHQ-9 is a validated 9-item measure of depression. The PHQ-9 has high sensitivity and 
specificity for identifying individuals with depressive symptoms, particularly among cancer survivors44-46. 
 
Functional Assessment of Cancer Therapy-General (FACT-G7)47: The FACT-G7 is a patient-reported 
outcome measure of health-related quality of life with good validity and reliability in patients with cancer47. 
 
Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A). The HADS-A is a validated 7-item 
patient-report measure of anxiety symptoms in the past week which has been used extensively among 
patients with advanced cancer48. 
 
  

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11.0 Data Analysis and Data Management  
 
Data Analysis 
Data analysis for Aims 1 and 2 will primarily focus on descriptive analysis of feasibility and acceptability 
metrics. Descriptive statistics will be summarized overall and within each intervention group for baseline 
demographic and clinical variables and for primary study outcomes. Descriptive analyses will be used to 
help determine feasibility of a future larger scale clinical trial with this patient population using these 
approaches. 
 
 
Data Management 
Participants will enter data in REDCap, a secure, web-based application designed exclusively to support 
data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data 
validation); 2) audit trails for tracking data manipulation and export procedures; 3) automated export 
procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R); 4) 
procedures for importing data from external sources; and 5) advanced features, such as branching logic and 
calculated fields. These procedures are effective in minimizing data entry errors (e.g., missing or errant 
data). All data from Moodivate will be stored on a HIPAA-compliant server and data will be transmitted 
securely to the research team via industry standard protocols as in our prior trials. Recruitment projects are 
housed in REDCap and only IRB approved study team members will have access to the recruitment project 
database. The research team will only have access to the REDCap recruitment project while actively 
enrolling for the study. 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
 
Quality Assurance 
Accuracy and completeness of the data collected will be ensured by weekly review. The REDCap system 
does not accept outliers, illogical response patterns, etc. The PIs and research staff will have weekly 
meetings to discuss any qualitative comments received during data collection and any problems in data 
collection. The PIs will examine the database for potential irregularities monthly. Initial data analyses will 
examine distributions of variable scores and comparability of baseline characteristics across conditions in 
case analyses need to be adjusted for these. Confidentiality procedures are outlined above.  
 
Regulatory Issues 
All serious AEs will be reported to the MUSC Committee on Human Research within 48-hours. Follow-up 
of all unexpected and serious AEs will also be reported. All AEs will be reviewed weekly by the PI and 
yearly by the IRB. Any significant actions taken by the local IRB and protocol changes will be relayed to 
the funding agency. We estimate the significant AE rate to be very low (< 5%). Potential conflicts of interest 
(COI) will be reported using the rules of MUSC’s COI committee. 
 
Trial Safety 
The contact PI (Dr. Dahne) will serve as the lead Program Manager for AEs. All unexpected AEs will be 
monitored while they are active to determine if treatment is needed. We anticipate that AEs will be rare 
given that the Moodivate app is non-invasive and that all participants will be engaged with current 
healthcare. For each weekly study meeting, the research assistant will prepare a summary of all AEs, 
including their severity, whether they caused a dropout, required treatment, and presumed relation to app 
utilization. The PIs will review this at the weekly study meeting (or before if more urgent). At the weekly 
meeting (or before if urgent), the research staff will report any premonitory symptoms to suggest emergence 
of a serious psychiatric condition (e.g., suicidality). The mPI, Dr. Graboyes, a board-certified head and neck 

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microvascular reconstructive surgeon-scientist, will be available on an ad-hoc basis for on-site medical 
supervision for any issues that cannot be resolved by Dr. Dahne.  
 
Study procedures will follow as much as possible the FDA’s Good Clinical Practice Guidelines and our 
research team has found Spilker’s comprehensive text on conducting clinical trials to be useful49. We will 
encourage participants to notify their physicians that a) they are in a randomized controlled research study 
examining a treatment for depressed mood, and b) the physician should contact the PI directly if the 
physician has any questions. 
  
The research staff will be instructed not to reveal whether a person is a participant in the study and will 
report to the PI any outside requests for information about a participant or any breaches in confidentiality. 
All requests by participant’s physicians and other medical providers will be referred directly to the PI.  
 
Data and Safety Monitoring Plan Administration 
The PIs will be responsible for monitoring the trial, with additional oversight provided by study co-
Investigators. The PIs will examine monthly the outcomes database for missing data, unexpected 
distributions or responses, and outliers. The PIs will check weekly the AE database prepared by the research 
staff immediately prior to the weekly lab meeting.  
 
13.0 Risks to Subjects 
This is considered a minimal risk study. Minimal risk means the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered 
in daily life or during the performance of routine physical or psychological examinations or tests. The 
potential risks in this study include those related to: a) depressive symptoms, b) clinical deterioration, c) 
confidentiality, d) potential data breach from the app database, and e) frustration. All risk mitigation 
strategies outlined have previously been approved by the MUSC IRB and implemented with success during 
our team’s prior Moodivate evaluation trials.  
a) Depressive symptoms: Depressive symptoms will be monitored via the PHQ-9. All participants will 
complete the PHQ-9 weekly online via a REDCap survey that is accessible via mobile phone web 
browsers. All participants will own smartphones. Thus, all participants should have access to the online 
PHQ-9 assessments. 
 
b) Clinical deterioration: Drs. Dahne, Graboyes, and their research team will monitor participant PHQ-
9 scores for possible clinical deterioration (i.e., increasing depressive symptoms and/or the development 
of suicidal ideation) throughout the course of the study as participants complete the PHQ-9 weekly. 
Clinical deterioration will be defined as an increase of 5 or more points on the PHQ-9 from the baseline 
PHQ-9 assessment or a response of “More than half the days” or “Nearly every day” on item 9 
(“Thoughts that you would be better off dead, or thoughts of hurting yourself in some way”) of the 
PHQ-9. Our team has developed real-time alerts in REDCap which alert the investigative team if a 
participant completes a PHQ-9 assessment and evidences clinical deterioration. This system was 
developed during our prior Moodivate evaluation studies and has now been implemented with success 
across multiple studies. In the event that a participant evidences clinical deterioration, Dr. Dahne, a 
licensed clinical psychologist, or other IRB-approved clinical personnel will contact the participant via 
phone and will provide referrals for local mental health resources for depression treatment. Dr. Dahne 
(or other IRB-approved clinical personnel) will suggest that the participant seek treatment and then will 
follow-up with the participant via phone one week later. In the event that a participant reports suicidal 
ideation either during study screening or during subsequent assessments, Dr. Dahne will complete a risk 
assessment with the participant via phone. Dr. Dahne will query the participant for details regarding the 
suicidal ideation, including a likelihood of harming oneself imminently and a plan for committing 

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suicide. If the participant reports an imminent likelihood of harming themself or a plan for committing 
suicide, Dr. Dahne will call emergency services and will remain on the phone with the participant until 
emergency services arrive. Contact information including home address will be collected during study 
screening and will be provided if necessary to emergency services personnel. If the participant does not 
respond to Dr. Dahne’s phone call within 24 hours, Dr. Dahne will contact the participant’s designated 
emergency contact (contact information for emergency contact will be collected at baseline). If neither 
the participant nor the emergency contact responds to Dr. Dahne within 48, Dr. Dahne will call local 
emergency services and will provide them with the participant’s name and home address for the 
purposes of completing a well check. These risk mitigation procedures will be reviewed with all 
participants during the informed consent process and are currently approved across all of our team’s 
IRB protocols. Dr. Dahne has more than 10 years of experience conducting suicide risk assessments. In 
the event that a participant evidences clinical deterioration, the participant will be allowed to continue 
in the trial, but we will recruit an additional participant for data collection purposes.  
 
c) Confidentiality: Participants will be made aware of limits to confidentiality at the beginning of 
screening and during informed consent which includes a report of suicidal or homicidal intent or report 
of abuse or neglect. If the participant reports suicidal or homicidal intent or abuse/neglect during 
screening or at any point during the trial, Dr. Dahne will take appropriate action as outlined by the 
MUSC IRB, NIH, and the State of South Carolina, which may include paging the participant’s 
oncologist, contacting the authorities and/or pursuing involuntary commitment at a mental health 
facility. If participants present no imminent danger but also need more extensive treatment of mental 
health concerns, they will be given appropriate referrals. All individual interviews will be recorded, 
transcribed, and destroyed within 12 months of completion of the entire study to protect confidentiality. 
 
d) Data breach: Although health information will be collected within Moodivate (e.g., daily mood 
ratings, activities, values), personally identifiable information will intentionally not be collected within 
the app (e.g., name, phone number, email address, etc), and thus we will not collect nor will we retain 
protected health information (PHI). In the event of a data breach, it is important to note that health 
information will not be able to be tracked back to specific individual users. By refraining from collecting 
PHI within the mobile app, we ensure HIPAA compliance while also protecting the identities of our 
users. In the event of a data breach, all app users will be notified via email.   
 
e) Frustration: Participants may become frustrated while completing questionnaires or while using 
Moodivate. Participants will be informed that they may refuse to answer any question(s) that they do 
not wish to answer and that they may discontinue use of Moodivate at any time. 
 
f) Randomization: The treatment participants receive may prove to be less effective or to have more 
side effects than the other study treatment(s) or other available treatments. 
 
e) Unknown risks: The experimental treatments may have unknown side effects. The researchers will 
let participants know if they learn anything during the course of the study that might make participants 
change their mind about participating in the study. 
 
Since patients will all currently be receiving medical care at HCC, there are no additional risks associated 
with participation in this study. 
 
Adequacy of Protection Against Risks  
Recruitment and Informed Consent 
Study participants will be recruited proactively and remotely via the EHR using the same procedures 
utilized in our team’s prior proactive behavioral health intervention trials. We will utilize available EHR 

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data to identify HCC patients with likely incurable cancer and depressive symptoms. Patients on the study 
recruitment report who have likely incurable cancer as denoted within the medical record will be sent a 
study invitation by the research team. If interested, participants will complete an online screening within 
REDCap to determine preliminary study eligibility. After completing determination of preliminary 
eligibility, a member of the research team will schedule a phone call with the participant to determine final 
study eligibility (no suicidal ideation reported on the PHQ-9 and a score >=10 on PHQ-9). After 
determination of final study eligibility, a study team member will complete remote electronic informed 
consent (e-consent) with the participant via REDCap. Participants will receive a link to an electronic 
consent form, available via REDCap, that they can review and sign. Review of the consent form will be 
paired with a phone call with a member of the research team to ensure that all questions are answered prior 
to enrollment. This remote consent procedure is currently utilized across all of Dr. Dahne’s current NIH-
funded awards. As smartphone ownership is an inclusion criterion (to use Moodivate), all participants will 
have internet access and thus access to the electronic consent form. All participants will electronically sign 
informed consent forms that have been IRB-approved once the study is explained to them in full and they 
have stated that they understand what is being asked of them. Participants will be given the opportunity to 
ask questions about their participation throughout the course of the study. A copy of the informed consent 
will be kept centrally at our study office within locked filing cabinets and a copy will also be given to each 
study participant. Participants will be given a study phone number and e-mail address to contact for 
questions. 
 
Protections Against Risk 
All screening information will be kept in a password protected REDCap database. Only key study personnel 
will have access to the database. If an individual is not eligible to participate, his/her screener will include 
his/her first name and last initial and the reason for disqualification. Eligible participants’ full name, 
telephone number and e-mail address will be recorded in the database. This is the only place where 
participants’ names and subject identification numbers appear together. Eligible participants will be 
assigned a subject number, will complete informed consent (see procedures above), will be randomized, 
will complete baseline assessments, and subsequently will receive their randomized intervention. 
 
Upon completing eligibility screening, if study eligible, individuals will be provided with a verbal overview 
of the study, asked to review a consent form, and asked to provide informed consent. Participants will be 
informed of limitations of confidentiality (i.e., abuse or neglect, intention to harm self or someone else) 
both verbally and in writing during the informed consent process. The consent form will include the 
participant’s name, but not his/her subject number. Consent forms will be provided in English. As utilization 
of Moodivate requires that participants are able to read, participants unable to read the consent form on their 
own will not be included. 
 
Regarding questionnaire data, data will be obtained for research purposes only. All data will be collected, 
stored, and managed via REDCap, which is a secure, web-based application designed exclusively to support 
data capture for research studies. REDCap includes real time validation rules with automated data type and 
range checks at the time of entry. The underlying database is hosted in a secure data center at MUSC and 
includes redundancy, failover capability, backups and extensive security checks. The system has several 
layers of protection including user/group account management, "Data Access Groups" which allow data to 
be entered by multiple groups in one database with segmented user rights for entered data, audit trails for 
all changes, queries and reports, and Secure Sockets Layer (SSL) encryption. Name and relevant contact 
information will be obtained to provide compensation and every effort will be made to maintain subject 
confidentiality, in accordance with HIPAA. All data will be identified only by code numbers (participant 
IDs). Participant IDs will be linked to participants’ names in a password-protected file that is accessible 
only to the PI and trained research staff.  
 

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Regarding user privacy while using Moodivate, users will create a username and password in order to login 
to their account without storing their true identity. In Moodivate, we will store a one-way hashed version 
of the patient’s email address to support password reset and unique identification, but that identification 
will not be traceable back to the user’s true identity. We will not store any personally identifiable 
information (e.g., first name, last name, email address, phone number) of users in our app database. We will 
use a HIPAA-compliant server protected by industry-standard safeguards to prevent unauthorized access. 
Since we are not associating patient health information with personally identifiable information there would 
not be a risk of unauthorized release of patient medical data in the event of a security breach. User personal 
information will be contained behind secured networks and will only be accessible by the investigators, 
who will have special access rights to such systems. In addition, all sensitive information users supply will 
be encrypted via Secure Socket Layer (SSL) technology. We will not sell, trade, or otherwise transfer 
personally identifiable information to outside parties. Our privacy policy will be available within the app 
for users to view at any time.    
 
Protection against risk resulting from depressive symptoms includes the following: Regarding suicidal 
ideation and broader mental health concerns, Dr. Dahne, a licensed clinical psychologist, will take 
appropriate action as outlined by the MUSC IRB, NIH, and the State of South Carolina, which may include 
contacting the authorities and/or pursuing involuntary commitment at a mental health facility. If participants 
present no imminent danger but also need more extensive treatment of mental health concerns, they will be 
given appropriate referrals. As noted above, PHQ-9 data will be monitored over time in order to detect any 
possible clinical deterioration. PHQ-9 data will be monitored using only the participants’ subject numbers. 
Should a participant evidence clinical deterioration, Dr. Dahne will then use the participant database to 
obtain contact information for the participant based on their subject number.  
 
Regarding recordings, all interviews will be audio recorded and transcribed with recordings stored on an 
MUSC secure, password protected server. Recordings will be destroyed within one year of recording. Only 
IRB approved research staff will have access to recordings. Recordings will be destroyed within 12 months 
of completion of the entire study. Only IRB approved research staff will have access to recordings. 
 
14.0 Potential Benefits to Subjects or Others 
All participants in this trial will receive at minimum treatment as usual. We will not augment treatment as 
usual as provided by HCC. The majority of participants will also receive a mobile app developed to improve 
depressive symptoms, therefore there is a possibility of reduced depressive symptoms through the use of 
Behavioral Activation for those that receive the Moodivate app. The major benefit to society will be whether 
a proactive identification + DMHI approach improves depression treatment outcomes relative to TAU for 
ILLIC. Potential issues of clinical deterioration, confidentiality, data security, and frustration are a high 
priority and will be closely monitored throughout the study. Consequently, the risk to benefit ratio in the 
proposed study appears to be acceptable. 
 
15.0 Sharing of Results with Subjects 
Study outcomes will not be shared with subjects. 
 
 
 

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