Health Care Workers and Mental Health

Anxiety Clinical Trial

Official title:

Evaluating the Effectiveness of an Enhanced Digital Mental Health Care Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028075
• Other study ID #: 848844
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1275
• Est. completion date: June 1, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Well-Being

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WHODAS	WHODAS is a 12-item questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Think back over the past 30 days and answer these questions, thinking about how much difficulty you had doing the following activities. For each question, please circle only one response.	9 months
Other	DSM-5 Level 1 Cross-Cutting Symptom Measure	DSM-5 Level 1 Cross-Cutting Symptom Measure	9 months
Primary	Depressive symptoms	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.	9 months
Primary	Anxiety	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.	9 months
Secondary	Well-being	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.	9 months
Secondary	Work productivity	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 (Lam et al, 2009).	9 months
Secondary	Satisfaction with care	Satisfaction Index- Mental Health (SIMH)(Nabati, Shea, McBride, Gavin, & Bauer, 1998). The SIMH is a 12-item, self-report instrument developed to measure patient satisfaction with mental health care (Nabati, et al., 1998). The SIMH has high internal consistency reliability (Cronbach's alpha = 0.90), test- retest reliability (r = 0.79, p = 0.05), and sensitivity to change (Nabati, et al., 1998).	9 months
Secondary	Psychological well-being	The 5-item World Health Organization Well- Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. Scoring principle: The raw score ranging from 0 to 25 is multiplied by 4 to give the final score from 0 representing the worst imaginable well-being to 100 representing the best imaginable well-being (Topp et al. 2015)	9 months
Secondary	Perceived System usability:	System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.	6 months