Covid19MHAPPSNCT04700137
Mental Health Among Patients, Providers, and Staff During the COVID-19 Era
A study testing Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC) in people with Covid19 and Mental Health, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.
Trial summary
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid19, Mental Health
- What is being tested?
- Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 6 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aim 1:
- Provider \& Employee Inclusion Criteria
- Provider or Employee at St. Luke's Health System
- Adults ≥ 18 years of age
- Proficient in spoken and written English language
- Patient Inclusion Criteria
Show all 29Show fewer
- Patient at a St. Luke's Health System primary care site
- Current MyChart account user
- Adults ≥18 years of age
- Minors 12-17 years of age
- Proficient in spoken and written English language
- Aim 2:
- Provider \& Employee Inclusion Criteria
- Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression:
- NIH Toolkit Loneliness raw score of 13 or greater or
- C-SSRS score of 3 or greater; or
- NIH Toolkit Perceived Stress raw score of 31 or greater for adults; or
- GAD7 score of 11 or greater; or
- PHQ9 score of 10 or greater
- Access to a phone for the duration of the study with the ability to receive text messages and phone calls
- Patient Inclusion Criteria
- Moderate or high score for loneliness, suicide ideation, psychological stress, anxiety, or depression:
- NIH Toolkit Loneliness raw score of 13 or greater for adults or 16 or greater for adolescents; or
- C-SSRS score of 3 or greater; or
- GAD7 score of 11 or greater; or
- PHQ9 score of 10 or greater; or
- NIH Toolkit Stress raw score of 31 or greater for adults or 33 or greater for adolescents
- [Note: validated youth versions of the NIH Toolkit assessments (loneliness and perceived stress), and PHQ-A tools will be used for adolescents; the C-SSRS and GAD7 tools are validated for use with both adults and adolescents.]
- Access to a phone for the duration of the study with the ability to receive text messages and phone calls
Who cannot join
- Aim 1:
- Provider \& Employee Exclusion Criteria
- Individuals who are unable or unwilling to provide informed consent to participate
- Individuals who are study staff for this study or the SPARC Trial
- Patient Exclusion Criteria
- Individuals who are unable or unwilling to provide informed consent to participate.
Show all 16Show fewer
- Individuals who are participants in the SPARC Trial
- Individuals who have not had a primary care visit in the past 12 months
- Aim 2:
- Provider \& Employee Exclusion Criteria
- Individuals who are unable or unwilling to provide informed consent to participate
- Individuals who are in acute crisis as determined by the person conducting the consent process
- Individuals who are study staff for this study or the SPARC Trial
- Individuals who are enrolled as participants in the SPARC comparative effectiveness clinical trial (SPARC Aim 1). Providers or employees who received training related to SPARC and/or who completed the SPARC provider satisfaction survey are not excluded from participating in MHAPPS
- Patient Exclusion Criteria
- Patients who are unable or unwilling to provide informed consent/assent to participate (or whose legally authorized representative is unable or unwilling to provide consent in the case of adolescents). Examples may include but are not limited to patients who present with acute or chronic cognitive impairment that would preclude their ability to consent (i.e. acute psychosis, intoxication, or intellectual disability).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Mental Health Impact of COVID-19 and Comparing the Effectiveness of Two Caring Contact Interventions on Patients, Providers, and Staff of St. Luke's Health System
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho.
The study will include:
Read more
Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and
Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.
Read the detailed description
Approximately 4,800 participants will complete the Aim 1 survey. The Caring Contacts intervention involves sending a series of brief, non-demanding, supportive text messages to the participant. One intervention arm will receive an introductory phone call and the caring text messages (CC+); the second intervention arm will only receive the same caring text messages (CC). The clinical trial will enroll a subset of 660 participants who report elevated levels of loneliness, suicide ideation, or other mental distress in the Aim 1 survey. Enrollment will be stratified by population (providers and employees; patients) with 165 per intervention arm in each stratum.
The investigators hypothesize that delivering the Caring Contacts intervention with an introductory phone call will yield better mental health outcomes than delivering the Caring Contacts intervention with no introductory phone call.
This will be the first published data directly comparing the effectiveness of two versions of the Caring Contacts intervention with individuals who report loneliness or other mental distress. The overall goal of the MHAPPS study is to better understand the mental health impact of COVID-19 and to determine how health systems can most effectively support mental health at scale among providers, staff, and patients in the COVID-19 era and beyond.
This research is being conducted by a team including health system-based researchers, clinicians, other frontline healthcare workers, and administrators; academic researchers; follow-up specialists and administrators at the Idaho Suicide Prevention Hotline, and an advisory board of people with lived experience with suicide.
- Conditions
- Covid19, Mental Health
- Being tested
- Caring Contacts Plus Introductory Phone Call (CC+), Caring Contacts without an introductory phone call (CC)
- Keywords
- Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts, Healthcare Staff, Healthcare Providers, Brief Contact Intervention, Adults, Adolescents
- Medical subject headings
- COVID-19, Psychological Well-Being, Anxiety Disorders, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring Contacts Plus Introductory Phone Call (CC+)Other
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.
Caring Contacts without an introductory phone call (CC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Caring Contacts + Introductory Phone Call (CC+) | Active comparator | Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call.
Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call. Receives: Other: Caring Contacts Plus Introductory Phone Call (CC+) |
| Caring Contacts (without phone call) (CC) | Active comparator | Healthcare provider and staff participants who are randomized to only caring text messages.
Adult and adolescent patient participants who are randomized to only caring text messages. Receives: Other: Caring Contacts without an introductory phone call (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
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.
Measured: Baseline and 6 Months
Secondary outcomes (8)
Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
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.
Measured: Baseline and 6 Months
Depression as Measured by the Patient Health Questionnaire (PHQ-9)
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.
Measured: Baseline and 6 Months
Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
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.
Measured: Baseline and 6 Months
Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
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.
Measured: Baseline and 6 Months
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
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.
Measured: Baseline and 6 Months
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
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.
Measured: Baseline and 6 Months
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
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.
Measured: Baseline and 6 Months
Number of Participants Who Attended Mental Healthcare Appointments: Self-Report
Participant engagement in outpatient mental health services will be measured as a dichotomous variable through self-report.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start18 Jan 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Health System, Boise, Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Idaho Crisis & Suicide Hotline, University of Washington
- Responsible party
- Principal investigator, Anna Radin, St. Luke's Health System, Boise, Idaho
- Investigators
- Anna K Radin, DrPH, MPH, Principal investigator, St. Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700137
- Sponsor's protocol ID
- 20-0052
- Other IDs
- PCORI HIS-2018C3-14695
- Acronym
- MHAPPS
- Status last verified
- May 2023
- First submitted
- 5 Jan 2021
- Last updated
- 25 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this trial may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the PIs.
Publications
Radin AK, Shaw J, Brown SP, Torres J, Harper M, Flint H, Fouts T, McCue E, Skeie A, Pena C, Youell J, Doty-Jones A, Wilson J, Flinn L, Austin G, Chan KCG, Zheng Z, Fruhbauerova M, Walton M, Kerbrat A, Comtois KA. Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. J Affect Disord. 2023 Jun 15;331:442-451. doi: 10.1016/j.jad.2023.03.029. Epub 2023 Mar 22.
PubMed 36963515
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Mental Health Impact of COVID-19 and Comparing the Effectiveness of Two Caring Contact Interventions on Patients, Providers, and Staff of St. Luke's Health System
- ClinicalTrials.gov ID
- NCT04700137
- Acronym / sponsor ID
- MHAPPS / 20-0052
- Conditions
- Covid19, Mental Health
- Keywords
- Loneliness, Anxiety, Depression, Suicidal Ideation, Social Distancing, Mental Distress, Pandemic, Caring Contacts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- St. Luke's Health System, Boise, IdahoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Idaho Crisis & Suicide Hotline, University of Washington
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Posted 25 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Mental Health Among Patients, Providers, and Staff (MHAPPS) Study is designed to study how the COVID-19 pandemic has affected mental health and wellbeing, and how to support mental health while minimizing the burden on the healthcare system. The study will enroll adults and adolescents who have had a primary care visit in the last 12 months, as well as healthcare providers and staff from a large health system in Idaho.
The study will include:
Aim 1: a cross sectional survey to measure the prevalence of various measures of mental distress and how they are associated with COVID-19-related factors; and
Aim 2: a randomized controlled trial comparing the effectiveness of two versions of a Caring Contacts intervention to reduce loneliness and mental distress.
Detailed description
Approximately 4,800 participants will complete the Aim 1 survey. The Caring Contacts intervention involves sending a series of brief, non-demanding, supportive text messages to the participant. One intervention arm will receive an introductory phone call and the caring text messages (CC+); the second intervention arm will only receive the same caring text messages (CC). The clinical trial will enroll a subset of 660 participants who report elevated levels of loneliness, suicide ideation, or other mental distress in the Aim 1 survey. Enrollment will be stratified by population (providers and employees; patients) with 165 per intervention arm in each stratum.
The investigators hypothesize that delivering the Caring Contacts intervention with an introductory phone call will yield better mental health outcomes than delivering the Caring Contacts intervention with no introductory phone call.
This will be the first published data directly comparing the effectiveness of two versions of the Caring Contacts intervention with individuals who report loneliness or other mental distress. The overall goal of the MHAPPS study is to better understand the mental health impact of COVID-19 and to determine how health systems can most effectively support mental health at scale among providers, staff, and patients in the COVID-19 era and beyond.
This research is being conducted by a team including health system-based researchers, clinicians, other frontline healthcare workers, and administrators; academic researchers; follow-up specialists and administrators at the Idaho Suicide Prevention Hotline, and an advisory board of people with lived experience with suicide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caring Contacts + Introductory Phone Call (CC+) | Active comparator | Other: Caring Contacts Plus Introductory Phone Call (CC+)Healthcare provider and staff participants who are randomized to both caring text messages and an introductory phone call. Adult and adolescent participants who are randomized to both caring text messages and an introductory phone call. |
| Caring Contacts (without phone call) (CC) | Active comparator | Other: Caring Contacts without an introductory phone call (CC)Healthcare provider and staff participants who are randomized to only caring text messages. Adult and adolescent patient participants who are randomized to only caring text messages. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- Provider \& Employee Inclusion Criteria
- Patient Inclusion Criteria
- Provider \& Employee Inclusion Criteria
- Patient Inclusion Criteria
Key exclusion criteria (16 listed)
- Provider \& Employee Exclusion Criteria
- Patient Exclusion Criteria
- Provider \& Employee Exclusion Criteria
- Patient Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Caring Contacts + Introductory Phone Call (CC+) |
| 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. | Other | Caring Contacts (without phone call) (CC) |
Primary outcome
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness
Time frame: Baseline and 6 Months
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.
8 secondary outcomes
Suicidal Ideation & Behavior as Measured by the Columbia Suicide Severity Rating Scale
Time frame: Baseline and 6 Months
Depression as Measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 6 Months
Anxiety as Measured by the Generalized Anxiety Disorder 7 Item Scale (GAD-7)
Time frame: Baseline and 6 Months
Change From Baseline in Psychological Stress as Measured by the National Institutes of Health (NIH) Toolbox Stress and Self-Efficacy Scales Perceived Stress Measure
Time frame: Baseline and 6 Months
Perceived Burdensomeness & Thwarted Belongingness as Measured by the Interpersonal Needs Questionnaire (INQ15)
Time frame: Baseline and 6 Months
Number of Participants Reporting Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale & Completed Suicide
Time frame: Baseline and 6 Months
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
Time frame: Baseline and 6 Months
Number of Participants Who Attended Mental Healthcare Appointments: Self-Report
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36963515Radin AK, Shaw J, Brown SP, Torres J, Harper M, Flint H, Fouts T, McCue E, Skeie A, Pena C, Youell J, Doty-Jones A, Wilson J, Flinn L, Austin G, Chan KCG, Zheng Z, Fruhbauerova M, Walton M, Kerbrat A, Comtois KA. Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. J Affect Disord. 2023 Jun 15;331:442-451. doi: 10.1016/j.jad.2023.03.029. Epub 2023 Mar 22.
- Individual participant dataSharing planned: Yes. Data from this trial may be requested from other researchers 5 years after the completion of the primary endpoint by contacting the PIs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna K Radin, DrPH, MPH principal investigator
St. Luke's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Contacts Plus Introductory Phone Call (CC+) and Caring Contacts without an introductory phone call (CC) in people with Covid19 and Mental Health, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness as Measured by the National Institutes of Health (NIH) Toolbox Social Relationship Scale for Loneliness (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.