Depression, AnxietyThriveNCT05931432
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
A study testing Comprehensive Well-Being Intervention in people with Depression, Anxiety and Satisfaction, run by University of Pennsylvania at 1 site in United States.
Trial summary
For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Satisfaction, Well-being
- What is being tested?
- Comprehensive Well-Being Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 27 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years of age;
- Interest in participating in an 18 month study and willing to complete regular surveys;
- Regular, daily access to a phone with texting capabilities
- Identify as a Physician at Penn Medicine;
Who cannot join
- Under 18 years of age;
- Not willing to sign informed consent document for an 18 month study;
- No access to a phone with texting capabilities;
- Not a Physician at Penn Medicine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic.
The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems.
Read more
Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources.
Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.
- Conditions
- Depression, Anxiety, Satisfaction, Well-being
- Being tested
- Comprehensive Well-Being Intervention
- Medical subject headings
- Depression, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Well-Being InterventionOther
The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will be asked to complete an ICF and baseline survey at enrollment. They will be given survey assessments at 0, 18 and 30 months. Survey assessments will include validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The control group will have access to usual care well-being resources at Penn Medicine. These include links, classes, groups, social media sites such as Penn Cobalt which require self-awareness to find the resources and access them. In this context, the individual has to "pull" the resources they need and there may be several barriers to completing each step |
| Comprehensive Well-Being Intervention | Experimental | Participants will be asked to complete an ICF and baseline survey at enrollment. Participants will complete a full assessment using validated instruments at enrollment, 18 months and 30 months (depression, anxiety, stress, resilience, and job satisfaction). Participants will also complete the brief well-being index (WBI, nine questions) every 3 months over 30 months. The primary endpoint is assessed at 18 months. A secondary endpoint of persistence of effect is measured at 30 months.
The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. Receives: Other: Comprehensive Well-Being Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 0
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 3
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 6
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 9
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 12
Well-Being Index (WBI)
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Measured: at month 15
Secondary outcomes (12)
Patient Health Questionnaire (PHQ-2)
PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.
Measured: at month 0
Patient Health Questionnaire (PHQ-2)
PHQ-2 and GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.
Measured: at month 18
General Anxiety Disorder (GAD-2)
GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.
Measured: at month 0
General Anxiety Disorder (GAD-2)
GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety. GAD-2 have been validated and used in multiple studies and provide easy, simple scales to quickly assess for depression and anxiety.
Measured: at month 18
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Measured: at month 0
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale is a 10-item well validated instrument in physician cohorts and measures stress
Measured: at month 18
Connor-Davidson Resilience Scale (CDRS)
The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience
Measured: at month 0
Connor-Davidson Resilience Scale (CDRS)
The Connor-Davidson Resilience Scale (CDRS) is a 2-item standardized and validated instrument in physician populations and measures bounce back and adaptability aspects of resilience
Measured: at month 18
Physician Job Satisfaction Scale (JSS-10)
The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure
Measured: at month 0
Physician Job Satisfaction Scale (JSS-10)
The Physician Job Satisfaction Scale (JSS-10) measures satisfaction at work and is a well validated 12-item measure
Measured: at month 18
Professional Fulfillment Index
- The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment.
Measured: at month 0
Professional Fulfillment Index
- The Professional Fulfillment Index (PFI) was developed to capture both burnout and professional fulfillment in the evaluation and assessment of professional wellbeing [18]. The PFI is a 16-item index that measures burnout and professional fulfillment.
Measured: at month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Oct 2023
- Primary completion27 Jul 2025
- Study completion27 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931432
- Sponsor's protocol ID
- 852022
- Acronym
- Thrive
- Status last verified
- May 2026
- First submitted
- 16 May 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
- ClinicalTrials.gov ID
- NCT05931432
- Acronym / sponsor ID
- Thrive / 852022
- Conditions
- Depression, Anxiety, Satisfaction, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 27 Jul 2025 (actual)
- First posted
- 5 Jul 2023 (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.
For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic.
The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems.
Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources.
Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will be asked to complete an ICF and baseline survey at enrollment. They will be given survey assessments at 0, 18 and 30 months. Survey assessments will include validated measures on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The control group will have access to usual care well-being resources at Penn Medicine. These include links, classes, groups, social media sites such as Penn Cobalt which require self-awareness to find the resources and access them. In this context, the individual has to "pull" the resources they need and there may be several barriers to completing each step |
| Comprehensive Well-Being Intervention | Experimental | Other: Comprehensive Well-Being InterventionParticipants will be asked to complete an ICF and baseline survey at enrollment. Participants will complete a full assessment using validated instruments at enrollment, 18 months and 30 months (depression, anxiety, stress, resilience, and job satisfaction). Participants will also complete the brief well-being index (WBI, nine questions) every 3 months over 30 months. The primary endpoint is assessed at 18 months. A secondary endpoint of persistence of effect is measured at 30 months. The intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age;
- Interest in participating in an 18 month study and willing to complete regular surveys;
- Regular, daily access to a phone with texting capabilities
- Identify as a Physician at Penn Medicine;
Key exclusion criteria (4 listed)
- Under 18 years of age;
- Not willing to sign informed consent document for an 18 month study;
- No access to a phone with texting capabilities;
- Not a Physician at Penn Medicine
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 |
|---|---|---|
| Comprehensive Well-Being InterventionThe intervention group will receive an 18-month comprehensive suite of services including: 1) monthly automated text messaging reminders about wellbeing resources focused on a range of topics (e.g. mindfulness, stress management, childcare support, racial trauma, diversity and inclusion) and assignment to a one-hour quarterly peer support group with an expectation of regular attendance. Half of these sessions will be self-directed discussion topics and half will be facilitated discussions. The content of monthly text messaging resources and discussion topics for the peer-support groups will be informed by the Aim 1 qualitative findings. | Other | Comprehensive Well-Being Intervention |
Primary outcome
Well-Being Index (WBI)
Time frame: at month 0
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Well-Being Index (WBI)
Time frame: at month 3
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Well-Being Index (WBI)
Time frame: at month 6
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Well-Being Index (WBI)
Time frame: at month 9
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Well-Being Index (WBI)
Time frame: at month 12
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
Well-Being Index (WBI)
Time frame: at month 15
The Well-being index (WBI) is a nine-question survey validated for use in physician populations and considered important to health systems in managing the well-being of their workforce. The domains address likelihood of burnout, severe fatigue, suicidal ideation, quality of life, meaning in work, work-life integration, risk of medical error, dropout risk, and overall well-being, It is brief (approximately 5 minutes to complete), easily tracked via a mobile app, and tracked across multiple health systems in Pennsylvania and across the United States. The WBI is also currently used by our health system for assessing HCW well-being and baseline survey
12 secondary outcomes
Patient Health Questionnaire (PHQ-2)
Time frame: at month 0
Patient Health Questionnaire (PHQ-2)
Time frame: at month 18
General Anxiety Disorder (GAD-2)
Time frame: at month 0
General Anxiety Disorder (GAD-2)
Time frame: at month 18
Perceived Stress Scale (PSS-10)
Time frame: at month 0
Perceived Stress Scale (PSS-10)
Time frame: at month 18
Connor-Davidson Resilience Scale (CDRS)
Time frame: at month 0
Connor-Davidson Resilience Scale (CDRS)
Time frame: at month 18
Physician Job Satisfaction Scale (JSS-10)
Time frame: at month 0
Physician Job Satisfaction Scale (JSS-10)
Time frame: at month 18
Professional Fulfillment Index
Time frame: at month 0
Professional Fulfillment Index
Time frame: at month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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. 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 Comprehensive Well-Being Intervention in people with Depression, Anxiety and Satisfaction, 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 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: finished, as of the sponsor's last update on 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Well-Being Index (WBI) (time frame: at month 0). The study lists 6 primary outcomes in all. 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 8 May 2026.