Health Care Workers and Mental Health

NCT05028075 | Completed Results DMC

• 2 other identifiers: 8488441R01MH127686-01
• Study Type: interventional
• Target: 1,275
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Well-Being

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months and baseline measurements

Secondary Outcomes (3)

• Well-being Score Change

  6 months and baseline measurements

• Work Productivity Score Change

  6 months and baseline measurements

• Psychological Well-being Score Change

  6 months and baseline measurements

Study Arms (2)

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.

Behavioral: Cobalt +

Interventions

Cobalt + 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 41364911 DERIVED

• 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.

  PMID: 38787562 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cobalt

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Limitations and Caveats

Participants were from a single, large, urban health system and needed daily access to a smartphone. Selection and non-responder bias may be present. Given the stigma with accessing mental health care, this study did not integrate mental health records or treatments received but rather gathered self-reported data from participants and data on appointments made.

Results Point of Contact

• Title: Director of Research
• Organization: Center for Digital Health

digitalhealth@uphs.upenn.edu

2674280125

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: November 29, 2021
• Primary Completion: March 10, 2023
• Study Completion: June 1, 2023
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-09

Locations

US (1)