Health Care Workers and Mental Health

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05028075

Enrollment

1275

Registered

2021-08-31

Start date

2021-11-29

Completion date

2023-06-01

Last updated

2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depressive Symptoms, Well-Being

Brief summary

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.

Interventions

BEHAVIORALCobalt +

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

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Depressive Symptom Score Change	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	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.

Secondary

Measure	Time frame	Description
Well-being Score Change	6 months and baseline measurements	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.
Work Productivity Score Change	6 months and baseline measurements	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.
Psychological Well-being Score Change	6 months and baseline measurements	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	633
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. 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.	642
Total	1,275

Baseline characteristics

Characteristic	Total	Intervention	Usual Care
Age, Continuous	38.6 age STANDARD_DEVIATION 10.9	38.6 age STANDARD_DEVIATION 10.6	38.6 age STANDARD_DEVIATION 11.1
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants	39 Participants	38 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1198 Participants	603 Participants	595 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
GAD-7	5.91 units on a scale STANDARD_DEVIATION 4.83	6.03 units on a scale STANDARD_DEVIATION 4.88	5.79 units on a scale STANDARD_DEVIATION 4.77
PHQ-9	5.81 units on a scale STANDARD_DEVIATION 4.97	5.92 units on a scale STANDARD_DEVIATION 5.19	5.71 units on a scale STANDARD_DEVIATION 4.74
Race (NIH/OMB) American Indian or Alaska Native	12 Participants	6 Participants	6 Participants
Race (NIH/OMB) Asian	109 Participants	55 Participants	54 Participants
Race (NIH/OMB) Black or African American	320 Participants	160 Participants	160 Participants
Race (NIH/OMB) More than one race	38 Participants	21 Participants	17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants	1 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	793 Participants	399 Participants	394 Participants
Sex: Female, Male Female	1063 Participants	534 Participants	529 Participants
Sex: Female, Male Male	212 Participants	108 Participants	104 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 633	0 / 642
other Total, other adverse events	0 / 633	0 / 642
serious Total, serious adverse events	0 / 633	0 / 642

Outcome results

Primary

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.