DepressionIMPACTNCT06582784
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
A study testing Behavioral Activation Therapy App and Treatment as Usual in people with Depression and Depressive Symptoms, run by Medical University of South Carolina at 1 site in United States.
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 our research team to assist with the treatment of depressed mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Symptoms, Cancer
- What is being tested?
- Behavioral Activation Therapy App and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- ILLIC (as determined during manual chart review)
- Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9
- Current owner of an iOS- or Android-compatible smartphone
- 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 language fluency
Who cannot join
- Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9
- Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:
- Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or
- Self-report of cognitive difficulties that impair functional independence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Jennifer Dahne, PhD, 843-876-2280, dahne@musc.edu
About this study
Official title: Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Likely Incurable Cancer
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 our research team 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.
Read more
All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 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 contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.
Read the detailed description
Individuals living with likely incurable cancer (ILLIC) are a heterogeneous, growing subpopulation of cancer survivors who live with cancer as a chronic relapsing disease. As a result of their transitions through multiple lines of cancer therapy and prognostic uncertainty, ILLIC have unique survivorship care needs. Principal among these is the need for depression treatment. Up to half of ILLIC report depressive symptoms with negative sequalae including lower quality of life, reduced adherence to anti-cancer therapies, suicidal ideation, and desire for hastened death. Numerous trials and meta-analyses 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 providers, limit access. Thus, ILLIC need feasible, accessible evidence-based depression treatment options3.
Consistent with Commission on Cancer accreditation standards, short depression screeners (e.g., PHQ-2) are routinely administered in oncology settings with results recorded in structured Electronic Health Record (EHR) fields. Despite widespread screening adoption, treatment referral rates remain low (10-50%) across cancer centers. To address this depression screening vs. treatment referral gap, screening data can be used to proactively (i.e., remotely, outside an encounter) link survivors in need of depression treatment to scalable options. While depression screening data can be readily used for proactive identification (ID), as noted by NCI, there is a critical need to develop methods to identify and enumerate ILLIC. Data necessary to determine curability likelihood (e.g., advanced stage, metastatic), are typically recorded in unstructured EHR fields, necessitating labor-intensive, manual chart review to identify ILLIC. To realize the goal of delivering scalable evidence-based depression care for ILLIC, accurate, automated approaches to identify ILLIC are needed.
Self-guided digital mental health interventions (DMHIs) can be paired with proactive ID to create a scalable depression treatment delivery model. Our team recently developed "Moodivate" as a DMHI-based approach to deliver Behavioral Activation, an evidence-based first-line depression treatment for cancer survivors. In a pilot that informs this R01, we: 1) gathered stakeholder feedback and tailored Moodivate for the unique needs of ILLIC, 2) developed infrastructure and refined the approach for proactive ID of ILLIC with depression, and 3) conducted a pilot RCT (N=15) to evaluate feasibility, acceptability, and preliminary efficacy of a proactive ID + DMHI approach. In our RCT, ILLIC with depressive symptoms were proactively identified via structured (depression) and unstructured (ILLIC) EHR data, remotely enrolled, and randomized to proactive ID + DMHI (Moodivate tailored for ILLIC) or proactive ID + usual care (UC). Our preliminary data show that this care delivery model is feasible (60% of eligible patients accrued; Moodivate mean rating of excellent on the System Usability Scale), acceptable (70% used Moodivate continuously for one month), and may improve depression (40% reported a clinically meaningful improvement). Importantly, a sustainable treatment model must also address chronic evidence-to-practice gaps. Thus, implementation outcomes and determinants of the proactive ID + DMHI approach must be concurrently evaluated across multiple care delivery levels to enhance future adoption.
- Conditions
- Depression, Depressive Symptoms, Cancer
- Being tested
- Behavioral Activation Therapy App, Treatment as Usual
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation Therapy AppBehavioural
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 UsualBehavioural
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 8 weeks with a final follow up at week 12.
| Study group | Role | What they receive |
|---|---|---|
| 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 8 weeks with a final follow up at 12 weeks. Receives: Behavioral: Treatment as Usual |
| 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 8 weeks with a final follow up at week 12. Receives: Behavioral: Behavioral Activation Therapy App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression
Change in the Patient Health Questionnaire (PHQ-9) score from baseline. The PHQ-9 scoring is 1-27 where 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, and 20-27 is severe depression.
Measured: 12 weeks
Secondary outcomes (3)
Change in Anxiety Symptoms
Change in the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A) score from baseline. Scoring is on a scale from 0-21 where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), and 11-21 = Abnormal (case).
Measured: 12 weeks
Change in Quality of Life
Change in the Functional Assessment of Cancer Therapy-General (FACT-G7) score from baseline. The scoring is 0-28 using a 5 point likert scale where the a higher score indicates a better the quality of life.
Measured: 12 weeks
Clinical Response Rate
The proportion of patients with a clinically meaningful improvement in depressive symptoms (decrease of ≥5 points on the Patient Health Questionnaire assessment) from baseline to each time point
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start28 Oct 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Dahne, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582784
- Sponsor's protocol ID
- Pro00137447
- Other IDs
- 1R01CA281740-01A1
- Acronym
- IMPACT
- Status last verified
- May 2026
- First submitted
- 30 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Likely Incurable Cancer
- ClinicalTrials.gov ID
- NCT06582784
- Acronym / sponsor ID
- IMPACT / Pro00137447
- Conditions
- Depression, Depressive Symptoms, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 our research team 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 your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 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 contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.
Detailed description
Individuals living with likely incurable cancer (ILLIC) are a heterogeneous, growing subpopulation of cancer survivors who live with cancer as a chronic relapsing disease. As a result of their transitions through multiple lines of cancer therapy and prognostic uncertainty, ILLIC have unique survivorship care needs. Principal among these is the need for depression treatment. Up to half of ILLIC report depressive symptoms with negative sequalae including lower quality of life, reduced adherence to anti-cancer therapies, suicidal ideation, and desire for hastened death. Numerous trials and meta-analyses 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 providers, limit access. Thus, ILLIC need feasible, accessible evidence-based depression treatment options3.
Consistent with Commission on Cancer accreditation standards, short depression screeners (e.g., PHQ-2) are routinely administered in oncology settings with results recorded in structured Electronic Health Record (EHR) fields. Despite widespread screening adoption, treatment referral rates remain low (10-50%) across cancer centers. To address this depression screening vs. treatment referral gap, screening data can be used to proactively (i.e., remotely, outside an encounter) link survivors in need of depression treatment to scalable options. While depression screening data can be readily used for proactive identification (ID), as noted by NCI, there is a critical need to develop methods to identify and enumerate ILLIC. Data necessary to determine curability likelihood (e.g., advanced stage, metastatic), are typically recorded in unstructured EHR fields, necessitating labor-intensive, manual chart review to identify ILLIC. To realize the goal of delivering scalable evidence-based depression care for ILLIC, accurate, automated approaches to identify ILLIC are needed.
Self-guided digital mental health interventions (DMHIs) can be paired with proactive ID to create a scalable depression treatment delivery model. Our team recently developed "Moodivate" as a DMHI-based approach to deliver Behavioral Activation, an evidence-based first-line depression treatment for cancer survivors. In a pilot that informs this R01, we: 1) gathered stakeholder feedback and tailored Moodivate for the unique needs of ILLIC, 2) developed infrastructure and refined the approach for proactive ID of ILLIC with depression, and 3) conducted a pilot RCT (N=15) to evaluate feasibility, acceptability, and preliminary efficacy of a proactive ID + DMHI approach. In our RCT, ILLIC with depressive symptoms were proactively identified via structured (depression) and unstructured (ILLIC) EHR data, remotely enrolled, and randomized to proactive ID + DMHI (Moodivate tailored for ILLIC) or proactive ID + usual care (UC). Our preliminary data show that this care delivery model is feasible (60% of eligible patients accrued; Moodivate mean rating of excellent on the System Usability Scale), acceptable (70% used Moodivate continuously for one month), and may improve depression (40% reported a clinically meaningful improvement). Importantly, a sustainable treatment model must also address chronic evidence-to-practice gaps. Thus, implementation outcomes and determinants of the proactive ID + DMHI approach must be concurrently evaluated across multiple care delivery levels to enhance future adoption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Other | Behavioral: Treatment as UsualParticipants 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 8 weeks with a final follow up at 12 weeks. |
| Moodivate | Experimental | Behavioral: Behavioral Activation Therapy AppParticipants 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 8 weeks with a final follow up at week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- ILLIC (as determined during manual chart review)
- Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9
- Current owner of an iOS- or Android-compatible smartphone
- Willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
Key exclusion criteria (4 listed)
- Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9
- Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as:
- Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or
- Self-report of cognitive difficulties that impair functional independence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation Therapy AppMoodivate 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. | Behavioural | Moodivate |
| Treatment as UsualParticipants 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 8 weeks with a final follow up at week 12. | Behavioural | Treatment as Usual |
Primary outcome
Change in Depression
Time frame: 12 weeks
Change in the Patient Health Questionnaire (PHQ-9) score from baseline. The PHQ-9 scoring is 1-27 where 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, and 20-27 is severe depression.
3 secondary outcomes
Change in Anxiety Symptoms
Time frame: 12 weeks
Change in Quality of Life
Time frame: 12 weeks
Clinical Response Rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Therapy App and Treatment as Usual in people with Depression and Depressive Symptoms, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Dahne, Ph.D. (843-876-2280, dahne@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.