Health Care Workers and Mental Health

NCT ID: NCT05028075

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2023-06-01

Brief 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 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.

Conditions

Depressive Symptoms; Anxiety; Well-Being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

Cobalt +

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older

2. Regular, daily access to an smartphone

3. Able to communicate fluently in English

4. 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.

Exclusion Criteria

1. Not aged 18 years or older

2. Does not have regular, daily access to a smartphone

3. Unable to communicate fluently in English

4. Does not work at least 4 hours per week in either a hospital or outpatient based setting.

5. Not willing to sign the informed consent document

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Agarwal 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.

Reference Type: DERIVED

PMID: 38787562 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01MH127686-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

848844

Identifier Type: -

Identifier Source: org_study_id