Trial Outcomes & Findings for Mental Health Among Patients, Providers, and Staff During the COVID-19 Era (NCT NCT04700137)
NCT ID: NCT04700137
Last Updated: 2024-01-25
Results Overview
The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.7 or more (adults) or 60 or more (youth) indicates moderate to high levels of loneliness.
COMPLETED
NA
666 participants
Baseline and 6 Months
2024-01-25
Participant Flow
Recruitment occurred between January 2021 and July 2021. All recruitment was completed virtually, with invitations to participate sent via email and via the electronic health record messaging service.
Randomization occurred once a potential participant joined a study enrollment phone call but before they consented to participate. This approach was practical given the electronic nature of the informed consent process and was recommended by the Data \& Safety Monitoring Committee as a way to include a description in writing of the assigned intervention on the informed consent form while masking participants to the details of the intervention arm to which they were not assigned.
Participant milestones
| Measure |
Patients -- Caring Contacts (Without Phone Call) (CC)
Patients randomized to only caring text messages.
Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.
|
Patients -- Caring Contacts + Introductory Phone Call (CC+)
Patients randomized to caring text messages and an introductory phone call.
Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.
|
Healthcare Providers/Staff -- Caring Contacts (Without Phone Call) (CC)
Healthcare Providers and staff randomized to only caring text messages.
Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.
|
Healthcare Providers/Staff -- Caring Contacts + Introductory Phone Call (CC+)
Healthcare providers and staff randomized to caring text messages and an introductory phone call.
Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
166
|
165
|
168
|
167
|
|
Overall Study
COMPLETED
|
165
|
159
|
165
|
166
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
3
|
1
|
Reasons for withdrawal
| Measure |
Patients -- Caring Contacts (Without Phone Call) (CC)
Patients randomized to only caring text messages.
Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.
|
Patients -- Caring Contacts + Introductory Phone Call (CC+)
Patients randomized to caring text messages and an introductory phone call.
Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.
|
Healthcare Providers/Staff -- Caring Contacts (Without Phone Call) (CC)
Healthcare Providers and staff randomized to only caring text messages.
Caring Contacts without an introductory phone call (CC): Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.
|
Healthcare Providers/Staff -- Caring Contacts + Introductory Phone Call (CC+)
Healthcare providers and staff randomized to caring text messages and an introductory phone call.
Caring Contacts Plus Introductory Phone Call (CC+): One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Health system employee type was only assessed for healthcare providers and staff.
Baseline characteristics by cohort
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Total
n=666 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
n=166 Participants
|
46.6 years
n=165 Participants
|
39.8 years
n=168 Participants
|
39.5 years
n=167 Participants
|
41 years
n=666 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=166 Participants
|
131 Participants
n=165 Participants
|
140 Participants
n=168 Participants
|
150 Participants
n=167 Participants
|
551 Participants
n=666 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=166 Participants
|
34 Participants
n=165 Participants
|
28 Participants
n=168 Participants
|
17 Participants
n=167 Participants
|
115 Participants
n=666 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=166 Participants
|
11 Participants
n=165 Participants
|
12 Participants
n=168 Participants
|
19 Participants
n=167 Participants
|
51 Participants
n=666 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=166 Participants
|
154 Participants
n=165 Participants
|
153 Participants
n=168 Participants
|
145 Participants
n=167 Participants
|
608 Participants
n=666 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=166 Participants
|
0 Participants
n=165 Participants
|
3 Participants
n=168 Participants
|
3 Participants
n=167 Participants
|
7 Participants
n=666 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=166 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=167 Participants
|
2 Participants
n=666 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=166 Participants
|
1 Participants
n=165 Participants
|
1 Participants
n=168 Participants
|
2 Participants
n=167 Participants
|
7 Participants
n=666 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=166 Participants
|
0 Participants
n=165 Participants
|
1 Participants
n=168 Participants
|
0 Participants
n=167 Participants
|
2 Participants
n=666 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=166 Participants
|
1 Participants
n=165 Participants
|
1 Participants
n=168 Participants
|
0 Participants
n=167 Participants
|
4 Participants
n=666 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=166 Participants
|
156 Participants
n=165 Participants
|
155 Participants
n=168 Participants
|
157 Participants
n=167 Participants
|
621 Participants
n=666 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=166 Participants
|
4 Participants
n=165 Participants
|
7 Participants
n=168 Participants
|
5 Participants
n=167 Participants
|
20 Participants
n=666 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=166 Participants
|
3 Participants
n=165 Participants
|
3 Participants
n=168 Participants
|
3 Participants
n=167 Participants
|
10 Participants
n=666 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=166 Participants
|
165 participants
n=165 Participants
|
168 participants
n=168 Participants
|
167 participants
n=167 Participants
|
666 participants
n=666 Participants
|
|
Health System Employee Type
Physicians & Advanced Practice Providers
|
—
|
—
|
8 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
8 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
16 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Pharmacy, Patient Access Specialists, Lab
|
—
|
—
|
26 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
20 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
46 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Trades & Food Service
|
—
|
—
|
1 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
2 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
3 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Nursing
|
—
|
—
|
57 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
67 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
124 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Office Work & Educators
|
—
|
—
|
62 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
60 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
122 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Senior Management
|
—
|
—
|
2 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
2 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
4 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Social Support Services
|
—
|
—
|
11 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
6 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
17 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
|
Health System Employee Type
Other
|
—
|
—
|
1 Participants
n=168 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
1 Participants
n=167 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
2 Participants
n=335 Participants • Health system employee type was only assessed for healthcare providers and staff.
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Intention to treat population - all participants who were randomized and consented.
The NIH Toolbox Social Relationship Scale for Loneliness is a validated method for measuring loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.7 or more (adults) or 60 or more (youth) indicates moderate to high levels of loneliness.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
Baseline Loneliness
|
64.4 T-score
Standard Deviation 9.9
|
64.4 T-score
Standard Deviation 10.3
|
62.6 T-score
Standard Deviation 9.3
|
62.5 T-score
Standard Deviation 9.5
|
|
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
Follow-up Loneliness (6 months)
|
61.9 T-score
Standard Deviation 10.7
|
60.8 T-score
Standard Deviation 10.3
|
61.2 T-score
Standard Deviation 11
|
61.3 T-score
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
The Columbia Suicide Severity Rating Scale (C-SSRS) 6-item screener (self-assessment lifetime-recent (baseline) and since last visit (6 months) for Primary Care settings versions will be used). The C-SSRS is a validated tool to assess suicidality. C-SSRS score is determined based on the highest question number to which the participant responds "yes". For example, a score of 5 would be assigned to a participant who responded "yes" to Question 5 and any or all preceding questions. Higher scores are indicative of greater risk for suicide. C-SSRS screener scores range from 0 to 6, with higher scores indicative of higher suicide risk. Scores of 3 and higher indicate moderate to high risk for suicide.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
Baseline C-SSRS
|
0.5 score on a scale
Standard Deviation 1.3
|
0.4 score on a scale
Standard Deviation 1.1
|
0.3 score on a scale
Standard Deviation 0.9
|
0.4 score on a scale
Standard Deviation 1.1
|
|
Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
Follow-up C-SSRS (6 months)
|
0.4 score on a scale
Standard Deviation 0.9
|
0.6 score on a scale
Standard Deviation 1.3
|
0.5 score on a scale
Standard Deviation 1.2
|
0.4 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
The PHQ-9 is a widely used and validated tool to screen for depression in primary care and other non-psychiatric settings. The tool is composed of 9 questions each with a response of 0-3 which generate a score from 0-27 with higher scores indicating a greater degree of depression. Scores are categorized in the following manner: a score of 5-9 is considered minimal depression, 10-14 is considered mild major, 15-19 is moderate major, and ≥20 is severe major.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Depression as Measured by the Patient Health Questionnaire (PHQ-9)
Baseline PHQ-9
|
10.5 score on a scale
Standard Deviation 6.1
|
10.0 score on a scale
Standard Deviation 6.0
|
8.4 score on a scale
Standard Deviation 5.0
|
8.6 score on a scale
Standard Deviation 5.4
|
|
Depression as Measured by the Patient Health Questionnaire (PHQ-9)
Follow-up PHQ-9 (6 months)
|
8.6 score on a scale
Standard Deviation 6.2
|
7.9 score on a scale
Standard Deviation 5.8
|
7.7 score on a scale
Standard Deviation 5.1
|
8.1 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
Symptoms of anxiety will be assessed using the GAD-7, a brief self-report scale frequently used in the identification of Generalized Anxiety Disorder. The tool is composed of seven items, which are rated 0-3 to generate a score from 0-21. Higher scores indicate a greater severity of generalized anxiety symptoms. Scores of 11 and higher indicate moderate to high anxiety.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
Baseline GAD-7
|
9.3 score on a scale
Standard Deviation 5.3
|
8.8 score on a scale
Standard Deviation 5.3
|
7.8 score on a scale
Standard Deviation 4.4
|
8.4 score on a scale
Standard Deviation 5.0
|
|
Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
Follow-up GAD-7 (6 months)
|
7.9 score on a scale
Standard Deviation 5.6
|
7.3 score on a scale
Standard Deviation 5.0
|
6.8 score on a scale
Standard Deviation 4.7
|
8.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
The National Institute of Health (NIH) Toolbox Self-Efficacy Scales Perceived Stress measure is a validated tool to measure the stress and coping resources of an individual. The measure is comprised of ten items which are scored and granted a t-score specific to adult or adolescent participants. Higher t-scores are indicative of higher levels of stress. T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. A T-score of 60.5 or more for adults or 60.8 or more in adolescents indicates moderate to high levels of stress.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
Baseline Perceived Stress
|
60.7 T-score
Standard Deviation 8.7
|
59.6 T-score
Standard Deviation 8.6
|
58.5 T-score
Standard Deviation 7.3
|
59.5 T-score
Standard Deviation 7.7
|
|
Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
Follow-up Perceived Stress (6 months)
|
56.5 T-score
Standard Deviation 10.7
|
55.3 T-score
Standard Deviation 10.1
|
55.1 T-score
Standard Deviation 9.2
|
57.6 T-score
Standard Deviation 9.6
|
|
Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
Change in Perceived Stress from Baseline to 6 months
|
-4.2 T-score
Standard Deviation 9.3
|
-4.4 T-score
Standard Deviation 8.0
|
-3.3 T-score
Standard Deviation 10.3
|
-1.9 T-score
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
The Interpersonal Needs Questionnaire (INQ) was developed from the Interpersonal Theory of Suicide and the 15-item version (INQ15) is a validated tool to measure both perceived burdensomeness (PB) (6 items, scores range from 6 to 42) and thwarted belongingness (TB) (9 items; scores range from 9 to 63). Individuals provide a self-report response to each item ranging from 1 (Not at all true for me) to 7 (Very true for me). The appropriate items are reverse coded, and items are summed to calculate the TB and PB subscale scores with higher scores indicating greater TB and PB. Clinical Cutoff scores predicting desire for death are 35 or greater for TB and 19 or greater for PB. Clinical cutoff scores predicting desire for suicide are 50 or greater for TB and 30 or greater for PB.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
Baseline INQ Perceived Burdensomeness
|
10.1 score on a scale
Standard Deviation 6.7
|
9.2 score on a scale
Standard Deviation 5.4
|
7.9 score on a scale
Standard Deviation 3.6
|
8.0 score on a scale
Standard Deviation 4.9
|
|
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
Follow-up INQ Perceived Burdensomeness (6 months)
|
9.6 score on a scale
Standard Deviation 6.8
|
9.5 score on a scale
Standard Deviation 6.7
|
8.4 score on a scale
Standard Deviation 5.1
|
8.5 score on a scale
Standard Deviation 5.1
|
|
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
Baseline INQ Thwarted Belongingness
|
31.1 score on a scale
Standard Deviation 11.1
|
30.3 score on a scale
Standard Deviation 11.4
|
31.4 score on a scale
Standard Deviation 10.0
|
30.4 score on a scale
Standard Deviation 11.8
|
|
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
Follow-up INQ Thwarted Belongingness (6 months)
|
29.3 score on a scale
Standard Deviation 12.2
|
27.6 score on a scale
Standard Deviation 12.3
|
27.8 score on a scale
Standard Deviation 12.3
|
28.6 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
Three elements of the full version of the Columbia Suicide Severity Rating Scale (C-SSRS) (lifetime-recent (baseline) and since last visit (6 months)) were complied to create a Suicide Attempts Survey. These measured self-reported aborted or self-interrupted suicide attempts, interrupted suicide attempts, and actual suicide attempts. Non-lethal self-harm and lethal means used for attempts or completions were also collected. These elements were not included in the C-SSRS score but were compared across the intervention groups. Medical records were used to measure suicide completion.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
Death by suicide
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
Attempted suicide
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
Interrupted/aborted suicide
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
The questions are adapted from the Youth Risk Behavior Survey and will contain additional questions to measure self-reported changes in alcohol or illicit-drug use since the beginning of the COVID-19 pandemic.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19
Increased tobacco use at follow-up (6 months)
|
23 Participants
|
13 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19
Increased alcohol use at follow-up (6 months)
|
42 Participants
|
38 Participants
|
52 Participants
|
55 Participants
|
|
Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19
Increased marijuana/cannabis use at follow-up (6 months)
|
15 Participants
|
19 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants Reporting Increased Alcohol, Tobacco, Marijuana, and Illicit Drug Use as Measured by Questions Adapted From Youth Risk Behavior Survey and Related to COVID-19
Increased illicit drug use at follow-up (6 months)
|
7 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The Intention to Treat population includes data for all participants who were randomized, completed study enrollment, and completed the baseline survey.
Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report.
Outcome measures
| Measure |
Patients - CC
n=166 Participants
Patients randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Patients - CC+
n=165 Participants
Patients randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
Healthcare Providers/Staff - CC
n=168 Participants
Healthcare providers and staff randomized to Caring Contacts without an introductory phone call (CC) intervention arm
|
Healthcare Providers/Staff - CC+
n=167 Participants
Healthcare providers and staff randomized to Caring Contacts with an introductory phone call (CC+) intervention arm
|
|---|---|---|---|---|
|
Number of Participants Who Attended Mental Healthcare Appointments: Self-Report
|
119 Participants
|
105 Participants
|
124 Participants
|
123 Participants
|
Adverse Events
Patients - CC
Patients - CC+
Healthcare Providers/Staff - CC
Healthcare Providers/Staff - CC+
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place