Stigma, SocialNCT04964570
Digital Mental Health Care for COVID-19 High-Risk Populations
A study testing Video _ behavioral change module in people with Stigma, Social and Help-Seeking Behavior, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
The mental health consequences of the COVID-19 pandemic are likely to be vast, exceeding the capacity of mental health services and delaying treatment for people in need, with devastating consequences for those affected. Emerging data suggest that frontline health workers (e.g. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social, Help-Seeking Behavior
- What is being tested?
- Video _ behavioral change module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,134 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Essential workers (including healthcare workers)
- Age of 18-80
- US resident
- English speaker
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The mental health consequences of the COVID-19 pandemic are likely to be vast, exceeding the capacity of mental health services and delaying treatment for people in need, with devastating consequences for those affected. Emerging data suggest that frontline health workers (e.g. physicians, nurses, EMTs) and essential workers (in industries such as energy, and food products and services) face particular risks for mental health problems during and after the COVID-19 outbreak.
To address the unprecedented mental health needs during and as a result of the COVID-19 pandemic this study will develop and test novel, cost-effective and scalable, digitally-delivered mental health interventions, and will test this approach by focusing on health care workers and other essential workers.
Read the detailed description
Stigma towards mental health care is a profound obstacle that interferes with individuals seeking these services. Research suggests that interventions that are based on social contact are the most efficient way to reduce stigma. By combining online video and interactive behavioral change modules, this study aims to address stigma and both empower essential workers (healthcare and non-healthcare workers) both to seek treatment for mental health issues as well as to reduce psychiatric symptoms by increasing social support, facilitating sleep hygiene, and maintaining physical exercise. A total of 4,200 members of these high-risk groups will be recruited to participate in a randomized controlled trial (RCT) testing the efficacy of the intervention.
The intervention will consist of brief videos in which empowered members of the respective high-risk group (presented by actors) share their COVID-19 related mental health problems and describe how they were able to confront their mental health problems, which in turn helped them seek mental health care. The video will be followed by a short, interactive, digital behavioral change module. Within each high-risk group, individuals will first be randomized to receive the video (one time), video plus booster (second administration of the video), or non-intervention video control.
The study will randomize participants within each high-risk group into one of three arms:
- Video + Behavioral Change Module, with Booster: 2-3-minute video (in which empowered members of the respective high-risk group (protagonists) share their COVID-19 related mental health problems and describe how they were able to confront their mental health problems, which in turn helped them seek mental health care) will be followed by 3-4-minute online digital behavioral change modules at days 1 and 14 of the study ("video+booster"); 2) Video + Behavioral change modules without Booster: 2-3-minute video will be followed by 3-4-minute online digital behavioral change modules at day 1 only ("video"); 3) No Intervention video (Control Arm): Participants randomized to this arm will receive video not related to mental health ("control"). Following the intervention, the study includes three follow-ups (day 14, 30, and 90) to examine longer-term effects.
- Conditions
- Stigma, Social, Help-Seeking Behavior
- Being tested
- Video _ behavioral change module
- Medical subject headings
- Social Stigma, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video _ behavioral change moduleBehavioural
A short video (primary outcome) that aimed at reducing stigma towards treatments and increasing help seeking intentions.
The behavioral change module (secondary outcome) is aimed at changing behaviors of sleep, exercise and social support.
| Study group | Role | What they receive |
|---|---|---|
| Video and behavioral change module (BCM) + booster | Experimental | Participants will watch the video and read the BCM twice (day 1 and day 14) Receives: Behavioral: Video _ behavioral change module |
| Video and behavioral change module (BCM) | Experimental | Participants will watch the video and read the BCM once (day 1 only) Receives: Behavioral: Video _ behavioral change module |
| Control | No intervention | This arm will recieved the same length video with a content that is not related to mental health and no BCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma (the SSOSH-3)
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Measured: immediately after the intervention
Stigma (3 items of the SSOSH-3)
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Measured: 14 days after the intervention
Stigma (3 items of the SSOSH-3)
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Measured: 30 days after the intervention
Stigma (3 items of the SSOSH-3)
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Measured: 90 days after the intervention
Help Seeking Intentions (3 items of the ATSPPH)
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Measured: Immediately after the intervention
Help Seeking Intentions (3 items of the ATSPPH)
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Measured: 14 days after the intervention
Help Seeking Intentions (3 items of the ATSPPH)
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Measured: 30 days after the intervention
Help Seeking Intentions (3 items of the ATSPPH)
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Measured: 90 days after the intervention
Secondary outcomes (12)
Behaviors questionnaire
Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline
Measured: 14 days after the intervention
Behaviors questionnaire
Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline
Measured: 30 days after the intervention
Behaviors questionnaire
Four questions about sleep (quality of sleep), exercise (amount of weekly exercise) and social habits (weekly number of people one contacted). We will measure change from baseline
Measured: 90 days after the intervention
Clinical outcome - Anxiety
Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)
Measured: 14 days after the intervention
Clinical outcome - Anxiety
Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)
Measured: 30 days after the intervention
Clinical outcome - Anxiety
Change from baseline in GAD-7 (range 0-21, higher score indicate more anxiety)
Measured: 90 days after the intervention
Clinical outcome - Depression
Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)
Measured: 14 days after the intervention
Clinical outcome - Depression
Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)
Measured: 30 days after the intervention
Clinical outcome - Depression
Change from baseline in PHQ-9 (range 0-27, higher score indicate more depression)
Measured: 90 days after the intervention
Clinical outcome - PTSD
Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)
Measured: 14 days after the intervention
Clinical outcome - PTSD
Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)
Measured: 30 days after the intervention
Clinical outcome - PTSD
Change from baseline in PC-PTSD (range 0-5, higher than 2 indicates high probability of PTSD)
Measured: 90 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start4 Aug 2021
- Primary completion25 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, NYSPI and Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964570
- Sponsor's protocol ID
- 8128
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying data of participants will be shared
Publications
Amsalem D, Fisch CT, Wall M, Liu J, Lazarov A, Markowitz JC, LeBeau M, Hinds M, Thompson K, Smith TE, Lewis-Fernandez R, Dixon LB, Neria Y. The role of income and emotional engagement in the efficacy of a brief help-seeking video intervention for essential workers. J Psychiatr Res. 2024 May;173:232-238. doi: 10.1016/j.jpsychires.2024.03.027. Epub 2024 Mar 27.
PubMed 38554618Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Neria Y, Dixon LB. Destigmatising mental health treatment and increasing openness to seeking treatment: randomised controlled trial of brief video interventions. BJPsych Open. 2022 Sep 16;8(5):e169. doi: 10.1192/bjo.2022.575.
PubMed 36111611Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Dixon LB, Neria Y. Brief Video Intervention to Increase Treatment-Seeking Intention Among U.S. Health Care Workers: A Randomized Controlled Trial. Psychiatr Serv. 2023 Feb 1;74(2):119-126. doi: 10.1176/appi.ps.20220083. Epub 2022 Sep 13.
PubMed 36097721
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Mental Health Care for COVID-19 High-Risk Populations
- ClinicalTrials.gov ID
- NCT04964570
- Acronym / sponsor ID
- 8128
- Conditions
- Stigma, Social, Help-Seeking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,134 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
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 consequences of the COVID-19 pandemic are likely to be vast, exceeding the capacity of mental health services and delaying treatment for people in need, with devastating consequences for those affected. Emerging data suggest that frontline health workers (e.g. physicians, nurses, EMTs) and essential workers (in industries such as energy, and food products and services) face particular risks for mental health problems during and after the COVID-19 outbreak.
To address the unprecedented mental health needs during and as a result of the COVID-19 pandemic this study will develop and test novel, cost-effective and scalable, digitally-delivered mental health interventions, and will test this approach by focusing on health care workers and other essential workers.
Detailed description
Stigma towards mental health care is a profound obstacle that interferes with individuals seeking these services. Research suggests that interventions that are based on social contact are the most efficient way to reduce stigma. By combining online video and interactive behavioral change modules, this study aims to address stigma and both empower essential workers (healthcare and non-healthcare workers) both to seek treatment for mental health issues as well as to reduce psychiatric symptoms by increasing social support, facilitating sleep hygiene, and maintaining physical exercise. A total of 4,200 members of these high-risk groups will be recruited to participate in a randomized controlled trial (RCT) testing the efficacy of the intervention.
The intervention will consist of brief videos in which empowered members of the respective high-risk group (presented by actors) share their COVID-19 related mental health problems and describe how they were able to confront their mental health problems, which in turn helped them seek mental health care. The video will be followed by a short, interactive, digital behavioral change module. Within each high-risk group, individuals will first be randomized to receive the video (one time), video plus booster (second administration of the video), or non-intervention video control.
The study will randomize participants within each high-risk group into one of three arms:
- Video + Behavioral Change Module, with Booster: 2-3-minute video (in which empowered members of the respective high-risk group (protagonists) share their COVID-19 related mental health problems and describe how they were able to confront their mental health problems, which in turn helped them seek mental health care) will be followed by 3-4-minute online digital behavioral change modules at days 1 and 14 of the study ("video+booster"); 2) Video + Behavioral change modules without Booster: 2-3-minute video will be followed by 3-4-minute online digital behavioral change modules at day 1 only ("video"); 3) No Intervention video (Control Arm): Participants randomized to this arm will receive video not related to mental health ("control"). Following the intervention, the study includes three follow-ups (day 14, 30, and 90) to examine longer-term effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized Controled Trial
| Arm | Type | Receives |
|---|---|---|
| Video and behavioral change module (BCM) + booster | Experimental | Behavioral: Video _ behavioral change moduleParticipants will watch the video and read the BCM twice (day 1 and day 14) |
| Video and behavioral change module (BCM) | Experimental | Behavioral: Video _ behavioral change moduleParticipants will watch the video and read the BCM once (day 1 only) |
| Control | No intervention | –This arm will recieved the same length video with a content that is not related to mental health and no BCM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Essential workers (including healthcare workers)
- Age of 18-80
- US resident
- English speaker
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Video _ behavioral change moduleA short video (primary outcome) that aimed at reducing stigma towards treatments and increasing help seeking intentions. The behavioral change module (secondary outcome) is aimed at changing behaviors of sleep, exercise and social support. | Behavioural | Video and behavioral change module (BCM), Video and behavioral change module (BCM) + booster |
Primary outcome
Stigma (the SSOSH-3)
Time frame: immediately after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Stigma (3 items of the SSOSH-3)
Time frame: 14 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Stigma (3 items of the SSOSH-3)
Time frame: 30 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Stigma (3 items of the SSOSH-3)
Time frame: 90 days after the intervention
Change in stigma items from baseline - higher score, indicate higher stigma (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time frame: Immediately after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time frame: 14 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time frame: 30 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH)
Time frame: 90 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
12 secondary outcomes
Behaviors questionnaire
Time frame: 14 days after the intervention
Behaviors questionnaire
Time frame: 30 days after the intervention
Behaviors questionnaire
Time frame: 90 days after the intervention
Clinical outcome - Anxiety
Time frame: 14 days after the intervention
Clinical outcome - Anxiety
Time frame: 30 days after the intervention
Clinical outcome - Anxiety
Time frame: 90 days after the intervention
Clinical outcome - Depression
Time frame: 14 days after the intervention
Clinical outcome - Depression
Time frame: 30 days after the intervention
Clinical outcome - Depression
Time frame: 90 days after the intervention
Clinical outcome - PTSD
Time frame: 14 days after the intervention
Clinical outcome - PTSD
Time frame: 30 days after the intervention
Clinical outcome - PTSD
Time frame: 90 days after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 38554618Amsalem D, Fisch CT, Wall M, Liu J, Lazarov A, Markowitz JC, LeBeau M, Hinds M, Thompson K, Smith TE, Lewis-Fernandez R, Dixon LB, Neria Y. The role of income and emotional engagement in the efficacy of a brief help-seeking video intervention for essential workers. J Psychiatr Res. 2024 May;173:232-238. doi: 10.1016/j.jpsychires.2024.03.027. Epub 2024 Mar 27.
- Derived from this study: PubMed 36111611Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Neria Y, Dixon LB. Destigmatising mental health treatment and increasing openness to seeking treatment: randomised controlled trial of brief video interventions. BJPsych Open. 2022 Sep 16;8(5):e169. doi: 10.1192/bjo.2022.575.
- Derived from this study: PubMed 36097721Amsalem D, Wall M, Lazarov A, Markowitz JC, Fisch CT, LeBeau M, Hinds M, Liu J, Fisher PW, Smith TE, Hankerson S, Lewis-Fernandez R, Dixon LB, Neria Y. Brief Video Intervention to Increase Treatment-Seeking Intention Among U.S. Health Care Workers: A Randomized Controlled Trial. Psychiatr Serv. 2023 Feb 1;74(2):119-126. doi: 10.1176/appi.ps.20220083. Epub 2022 Sep 13.
- Individual participant dataSharing planned: No. No identifying data of participants will be shared
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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.
Yuval Neria, PhD principal investigator
NYSPI and Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video _ behavioral change module in people with Stigma, Social and Help-Seeking Behavior, run by Research Foundation for Mental Hygiene, Inc. 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 4 inclusion and 1 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 17 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stigma (the SSOSH-3) (time frame: immediately after the intervention). The study lists 8 primary outcomes in all. 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 NCT04964570, which also lists 3 linked publications.
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 17 Feb 2022.