Depressive SymptomsNCT04463914
Evaluation of a Mobile Therapy for Elevated Depressive Symptoms
A study testing Behavioral Activation Therapy app, Behavioral Activation Therapy app + EHR and Treatment as Usual in people with Depressive Symptoms and Depression, 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. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Depression
- What is being tested?
- Behavioral Activation Therapy app, Behavioral Activation Therapy app + EHR 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
- 649 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9)57
- 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 current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
- Enrolled in Epic's MyChart program
- English fluency
Who cannot join
- Current suicidal ideation at study screening, defined as a response >1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.
- Conditions
- Depressive Symptoms, Depression
- Being tested
- Behavioral Activation Therapy app, Behavioral Activation Therapy app + EHR, Treatment as Usual
- Medical subject headings
- Depression
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.
Behavioral Activation Therapy app + EHRBehavioural
Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. 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 PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Group A- 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 PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. Receives: Behavioral: Treatment as Usual |
| Group B- 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. 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 questionnaire at 12 weeks following study enrollment. Receives: Behavioral: Behavioral Activation Therapy app |
| Group C- Moodivate + EHR | Experimental | Participants randomized to the Moodivate + EHR condition will receive similar instructions as those randomized to Moodivate, but will also be instructed that their PCP will have access to metrics related to their app utilization and may choose to follow-up with them regarding treatment utilization and response. The PCP for each participant randomized to this condition will be provided EHR access to Moodivate metrics which will include metrics related to change in mood, frequency of app utilization, and frequency of activity completion. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. Receives: Behavioral: Behavioral Activation Therapy app + EHR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of Depressive Symptoms
Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.
Measured: Between baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start12 Oct 2021
- Primary completion4 Jan 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Dahne, Medical University of South Carolina
- Investigators
- Jennifer Dahne, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463914
- Sponsor's protocol ID
- 00096156
- Other IDs
- 5R42MH108219-04
- Status last verified
- Oct 2024
- First submitted
- 6 Jul 2020
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dahne J, Wahlquist AE, Carpenter MJ, Graboyes EM, Lejuez CW, Kustanowitz J, Natale N, Levins O, Player M, Diaz VA. A Digital Depression Treatment Program for Adults Treated in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):692-701. doi: 10.1001/jamainternmed.2025.0494.
PubMed 40227715
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04463914
- Acronym / sponsor ID
- 00096156
- Conditions
- Depressive Symptoms, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Posted 19 Nov 2024
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. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A- 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 PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. |
| Group B- 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. 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 questionnaire at 12 weeks following study enrollment. |
| Group C- Moodivate + EHR | Experimental | Behavioral: Behavioral Activation Therapy app + EHRParticipants randomized to the Moodivate + EHR condition will receive similar instructions as those randomized to Moodivate, but will also be instructed that their PCP will have access to metrics related to their app utilization and may choose to follow-up with them regarding treatment utilization and response. The PCP for each participant randomized to this condition will be provided EHR access to Moodivate metrics which will include metrics related to change in mood, frequency of app utilization, and frequency of activity completion. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9)57
- 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 current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
Key exclusion criteria (1 listed)
- Current suicidal ideation at study screening, defined as a response >1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")
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 | Group B- Moodivate |
| Behavioral Activation Therapy app + EHRMoodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. 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 | Group C- Moodivate + EHR |
| Treatment as UsualParticipants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. 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 | Group A- Treatment as Usual |
Primary outcome
Mean Score of Depressive Symptoms
Time frame: Between baseline and week 12
Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40227715Dahne J, Wahlquist AE, Carpenter MJ, Graboyes EM, Lejuez CW, Kustanowitz J, Natale N, Levins O, Player M, Diaz VA. A Digital Depression Treatment Program for Adults Treated in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):692-701. doi: 10.1001/jamainternmed.2025.0494.
- Individual participant dataSharing planned: No
Related trials for Depressive Symptoms
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
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. This study is not recruiting at the moment.
Jennifer Dahne, PhD principal investigator
Medical University of South Carolina
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, Behavioral Activation Therapy app + EHR and Treatment as Usual in people with Depressive Symptoms and Depression, 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 1 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: finished, as of the sponsor's last update on 19 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of Depressive Symptoms (time frame: Between baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463914, which also lists 1 linked publication.
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 19 Nov 2024.