Depressive SymptomsNCT05028075
Health Care Workers and Mental Health
A study testing Cobalt + in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Well-Being
- What is being tested?
- Cobalt +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,275 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 1 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Regular, daily access to an smartphone
- Able to communicate fluently in English
- Work at least 4 hours per week in either a hospital or outpatient based setting. This includes health care workers like physicians, nurses, certified nursing assistants, lab technicians, radiology technicians, physical therapist, occupational therapist, pharmacists, pharmacy technicians, patient registration staff, receptionists/patient intake coordinators, environmental and food service personnel approximately 4 hours/week. This averages 192 hours/ 48 weeks in a year) in the study time frame.
Who cannot join
- Not aged 18 years or older
- Does not have regular, daily access to a smartphone
- Unable to communicate fluently in English
- Does not work at least 4 hours per week in either a hospital or outpatient based setting.
- Not willing to sign the informed consent document
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating the Effectiveness of an Enhanced Digital Mental Health Care Delivery System
The purpose of this proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at present and presumably for years to come. This proposal will evaluate the effectiveness of an enhanced digital mental health care delivery system (Cobalt), any differential effect by race and gender and, through qualitative interviews, how those interventions are perceived.
Read the detailed description
The purpose of this proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at present and presumably for years to come. This proposal will evaluate the effectiveness of an enhanced digital mental health care delivery system (Cobalt), any differential effect by race and gender and, through qualitative interviews, how those interventions are perceived. No Intervention: Usual Care, Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity, hours of direct patient care, percent of time providing care for patients with COVID-19) at enrollment; 0 months, 6 months, and 9 months. Behavioral: Cobalt +: Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months. The primary endpoint is assessed at 6 months. A secondary endpoint of persistence of effect is measured 3 months later-9 months post initiation. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results.
- Conditions
- Depressive Symptoms, Anxiety, Well-Being
- Being tested
- Cobalt +
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobalt +Behavioural
Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months. The primary endpoint is assessed at 6 months. A secondary endpoint of persistence of effect is measured 3 months later-9 months post initiation. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity, hours of direct patient care, percent of time providing care for patients with COVID-19) at enrollment; 0 months, 6 months, and 9 months. |
| Intervention | Experimental | Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months and 9 months. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results. Receives: Behavioral: Cobalt + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Score Change
Patient health questionnaire-9 (PHQ-9) (Kroenke, Spitzer, \& Williams, 2001) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. PHQ-9 is brief and useful in clinical practice. The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-9 is a freely available mood-rating questionnaire consisting of nine questions mirroring DSM-IV depression diagnostic criteria. The PHQ-9 has shown diagnostic validity in a study of 3,000 adult patients. Each item is rated on a scale of 0 to 3, giving a maximum score of 24. Cut-off scores are used to label depression severity as: 0 to 4, minimal depression; 5 to 9, mild depression; 10 to 14, moderate depression; 15 to 19, moderately severe depression; 20 to 24, severe depression.
Measured: 6 months and baseline measurements
Anxiety Symptoms Score Change
GAD-7 is a 7-item anxiety scale. It has good reliability, as well as criterion, construct, factorial, and procedural validity. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day with a maximum score of 21 Scores are interpreted as 5 to 9, mild anxiety; 10 to 14, moderate anxiety; and 15 and above, severe anxiety. The GAD-7 showed good reliability and criterion, construct, factorial, and procedural validity in a study carried out in 15 primary care clinics. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
Measured: 6 months and baseline measurements
Secondary outcomes (3)
Well-being Score Change
The Well-being index (WBI) is a nine-question survey validated for use in Health Care Worker populations and considered important to health systems in managing the well-being of their workforce. The original 7-item WBI items are answered ''yes/no'' with 1 point assigned for each ''yes'' response. A total score (0 - 7) is calculated by adding the number of ''yes'' responses. A higher score indicative of worse well-being.
Measured: 6 months and baseline measurements
Work Productivity Score Change
To evaluate work productivity, we will use Lam Employment Absence and Productivity Scale, or LEAPS. It is a 10-item, self-rated scale that takes only 3 to 5 minutes for the patient to complete. It is simple and easy to use. The items were chosen based on the symptoms that have the most impact on work productivity and the most common productivity problems experienced by patients with depression. The LEAPS was recently validated in a sample of 234 consecutive working patients meeting DSM-IV criteria for MDD attending a mood disorders outpatient clinic. Each question has 5 choices ranging from none of the time, some of the time, half of the time, most of the time, and all of the time. Each choice is scored from 0 to 4. The total score is summing the 7 questions, the total score can range from 0 to 28. A lower score represents no to minimal work impairment while a higher score represents severe work impairment.
Measured: 6 months and baseline measurements
Psychological Well-being Score Change
The 5-item World Health Organization Well- Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. The five questions are scored from 0 to 5. The raw score is calculated by totaling the figures of the five answers.The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life. To obtain a percentage score, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.
Measured: 6 months and baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start29 Nov 2021
- Primary completion10 Mar 2023
- Study completion1 Jun 2023
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 (2)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 University of PennsylvaniaThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028075
- Sponsor's protocol ID
- 848844
- Other IDs
- 1R01MH127686-01
- Status last verified
- Sep 2024
- First submitted
- 25 Aug 2021
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Southwick L, Gonzales R, Bellini L, Asch DA, Mitra N, Balachandran M, Wolk CB, Becker-Haimes EM, Kishton R, Beck S, Merchant RM, Agarwal AK. Proactively Delivered Digital Mental Health Support for Health Care Workers: Usability and Acceptability Evaluation. JMIR Form Res. 2025 Dec 9;9:e74086. doi: 10.2196/74086.
PubMed 41364911Agarwal AK, Southwick L, Gonzales RE, Bellini LM, Asch DA, Shea JA, Mitra N, Yang L, Josephs M, Kopinksy M, Kishton R, Balachandran M, Benjamin Wolk C, Becker-Haimes EM, Merchant RM. Digital Engagement Strategy and Health Care Worker Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410994. doi: 10.1001/jamanetworkopen.2024.10994.
PubMed 38787562
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Enhanced Digital Mental Health Care Delivery System
- ClinicalTrials.gov ID
- NCT05028075
- Acronym / sponsor ID
- 848844
- Conditions
- Depressive Symptoms, Anxiety, Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 2 Oct 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 proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at present and presumably for years to come. This proposal will evaluate the effectiveness of an enhanced digital mental health care delivery system (Cobalt), any differential effect by race and gender and, through qualitative interviews, how those interventions are perceived.
Detailed description
The purpose of this proposal is to deploy digital health interventions to bring timely, easily accessible resources and care to address the mental health and well-being needs of HCWs with direct patient care that are experiencing the impact of the COVID-19 pandemic and its economic, financial, and social sequelae at present and presumably for years to come. This proposal will evaluate the effectiveness of an enhanced digital mental health care delivery system (Cobalt), any differential effect by race and gender and, through qualitative interviews, how those interventions are perceived. No Intervention: Usual Care, Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity, hours of direct patient care, percent of time providing care for patients with COVID-19) at enrollment; 0 months, 6 months, and 9 months. Behavioral: Cobalt +: Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months. The primary endpoint is assessed at 6 months. A secondary endpoint of persistence of effect is measured 3 months later-9 months post initiation. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity, hours of direct patient care, percent of time providing care for patients with COVID-19) at enrollment; 0 months, 6 months, and 9 months. |
| Intervention | Experimental | Behavioral: Cobalt +Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months and 9 months. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Regular, daily access to an smartphone
- Able to communicate fluently in English
- Work at least 4 hours per week in either a hospital or outpatient based setting. This includes health care workers like physicians, nurses, certified nursing assistants, lab technicians, radiology technicians, physical therapist, occupational therapist, pharmacists, pharmacy technicians, patient registration staff, receptionists/patient intake coordinators, environmental and food service personnel approximately 4 hours/week. This averages 192 hours/ 48 weeks in a year) in the study time frame.
Key exclusion criteria (5 listed)
- Not aged 18 years or older
- Does not have regular, daily access to a smartphone
- Unable to communicate fluently in English
- Does not work at least 4 hours per week in either a hospital or outpatient based setting.
- Not willing to sign the informed consent document
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 |
|---|---|---|
| Cobalt +Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months. The primary endpoint is assessed at 6 months. A secondary endpoint of persistence of effect is measured 3 months later-9 months post initiation. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an appointment based on their results. | Behavioural | Intervention |
Primary outcome
Depressive Symptom Score Change
Time frame: 6 months and baseline measurements
Patient health questionnaire-9 (PHQ-9) (Kroenke, Spitzer, \& Williams, 2001) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. PHQ-9 is brief and useful in clinical practice. The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The PHQ-9 is a freely available mood-rating questionnaire consisting of nine questions mirroring DSM-IV depression diagnostic criteria. The PHQ-9 has shown diagnostic validity in a study of 3,000 adult patients. Each item is rated on a scale of 0 to 3, giving a maximum score of 24. Cut-off scores are used to label depression severity as: 0 to 4, minimal depression; 5 to 9, mild depression; 10 to 14, moderate depression; 15 to 19, moderately severe depression; 20 to 24, severe depression.
Anxiety Symptoms Score Change
Time frame: 6 months and baseline measurements
GAD-7 is a 7-item anxiety scale. It has good reliability, as well as criterion, construct, factorial, and procedural validity. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day with a maximum score of 21 Scores are interpreted as 5 to 9, mild anxiety; 10 to 14, moderate anxiety; and 15 and above, severe anxiety. The GAD-7 showed good reliability and criterion, construct, factorial, and procedural validity in a study carried out in 15 primary care clinics. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
3 secondary outcomes
Well-being Score Change
Time frame: 6 months and baseline measurements
Work Productivity Score Change
Time frame: 6 months and baseline measurements
Psychological Well-being Score Change
Time frame: 6 months and baseline measurements
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41364911Southwick L, Gonzales R, Bellini L, Asch DA, Mitra N, Balachandran M, Wolk CB, Becker-Haimes EM, Kishton R, Beck S, Merchant RM, Agarwal AK. Proactively Delivered Digital Mental Health Support for Health Care Workers: Usability and Acceptability Evaluation. JMIR Form Res. 2025 Dec 9;9:e74086. doi: 10.2196/74086.
- Derived from this study: PubMed 38787562Agarwal AK, Southwick L, Gonzales RE, Bellini LM, Asch DA, Shea JA, Mitra N, Yang L, Josephs M, Kopinksy M, Kishton R, Balachandran M, Benjamin Wolk C, Becker-Haimes EM, Merchant RM. Digital Engagement Strategy and Health Care Worker Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410994. doi: 10.1001/jamanetworkopen.2024.10994.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cobalt + in people with Depressive Symptoms and Anxiety, run by University of Pennsylvania 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 4 inclusion and 5 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 2 Oct 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 2 Oct 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?
Depressive Symptom Score Change (time frame: 6 months and baseline measurements). The study lists 2 primary outcomes in all. 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 NCT05028075, which also lists 2 linked publications.
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 2 Oct 2024.