Stigma, SocialNCT05826132
Digital Mental Health Care for COVID-19 High-Risk Populations - Phase 2
A study testing Adjusted Content Intervention and Non-Adjusted Intervention Video 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 (Coronavirus Disease of 2019) 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 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social, Help-Seeking Behavior
- What is being tested?
- Adjusted Content Intervention and Non-Adjusted Intervention Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,402 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Jan 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Essential worker
- Ages 18-35
- English-speaking, able to provide consent
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 (Coronavirus Disease of 2019) 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, emergency medical technicians) 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. Additionally, our previous findings have shown that among these higher risk individuals, young adults and women reported greater levels of clinical symptoms.
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 with an eye toward the young adult portion of this population.
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. A previous phase of this study also showed that participants of certain minority groups (Black participants and female participants) were more impacted by the intervention when it was delivered by a presenter who shared their demographic characteristics. By utilizing an online video intervention, this study aims to address stigma and empower essential workers (healthcare and non-healthcare workers) to seek treatment for mental health issues. As a secondary aim, this study will examine whether the intervention results in behavioral changes in help-seeking. The investigators will study this by adding a link to a database of mental health care providers and measuring the number of times participants click on the link. A total of 1,400 young adult 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. Within each high-risk group, individuals will first be randomized to receive either the video intervention, with content adjusted to the presenter's young adult, female, Latino identity, the intervention video without any identity-based content, or non-intervention control.
The study will randomize participants within each high-risk group into one of three arms:
- Adjusted Content Intervention Video: 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman; 2) Non-Adjusted Intervention Video: 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics; 3) No Intervention (Control Arm): Participants randomized to this arm will view a video of the presenter describing daily activities, without mention of COVID-19 or mental health. Thirty days following the intervention, a follow-up assessment will examine longer-term effects.
- Conditions
- Stigma, Social, Help-Seeking Behavior
- Being tested
- Adjusted Content Intervention, Non-Adjusted Intervention Video
- 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.
Adjusted Content InterventionOther
2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman
Non-Adjusted Intervention VideoOther
2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics
| Study group | Role | What they receive |
|---|---|---|
| Adjusted Content Intervention Video | Experimental | Participants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman. Receives: Other: Adjusted Content Intervention |
| Non-Adjusted Intervention Video | Experimental | Participants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics. Receives: Other: Non-Adjusted Intervention Video |
| Control Arm | No intervention | Participants will watch a control video discussing daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma (the Self Stigma of Seeking Help Scale - 3 item) (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: 30 days after the intervention
Help Seeking Intentions (3 items of the Attitudes Toward Seeking Professional Psychological Help) (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: 30 days after the intervention
Secondary outcomes (1)
Number of Referral Clicks
Number of clicks on link to referrals to mental health care provider database
Measured: Immediately 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 posted24 Apr 2023
- Study start1 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,402 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
- NCT05826132
- Sponsor's protocol ID
- 8128a
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2023
- Last updated
- 18 Dec 2024
- 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
Fisch CT, Lazarov A, Lewis-Fernandez R, Dixon LB, Neria Y, Amsalem D. Brief Video Intervention to Increase Treatment-Seeking Intentions Among Young Adults With Psychiatric Symptoms: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Oct 27;86(4):25m15881. doi: 10.4088/JCP.25m15881.
PubMed 41159853
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. 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 - Phase 2
- ClinicalTrials.gov ID
- NCT05826132
- Acronym / sponsor ID
- 8128a
- Conditions
- Stigma, Social, Help-Seeking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,402 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 24 Apr 2023 (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 (Coronavirus Disease of 2019) 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, emergency medical technicians) 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. Additionally, our previous findings have shown that among these higher risk individuals, young adults and women reported greater levels of clinical symptoms.
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 with an eye toward the young adult portion of this population.
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. A previous phase of this study also showed that participants of certain minority groups (Black participants and female participants) were more impacted by the intervention when it was delivered by a presenter who shared their demographic characteristics. By utilizing an online video intervention, this study aims to address stigma and empower essential workers (healthcare and non-healthcare workers) to seek treatment for mental health issues. As a secondary aim, this study will examine whether the intervention results in behavioral changes in help-seeking. The investigators will study this by adding a link to a database of mental health care providers and measuring the number of times participants click on the link. A total of 1,400 young adult 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. Within each high-risk group, individuals will first be randomized to receive either the video intervention, with content adjusted to the presenter's young adult, female, Latino identity, the intervention video without any identity-based content, or non-intervention control.
The study will randomize participants within each high-risk group into one of three arms:
- Adjusted Content Intervention Video: 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman; 2) Non-Adjusted Intervention Video: 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics; 3) No Intervention (Control Arm): Participants randomized to this arm will view a video of the presenter describing daily activities, without mention of COVID-19 or mental health. Thirty days following the intervention, a follow-up assessment will 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 controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adjusted Content Intervention Video | Experimental | Other: Adjusted Content InterventionParticipants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman. |
| Non-Adjusted Intervention Video | Experimental | Other: Non-Adjusted Intervention VideoParticipants will watch a 2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics. |
| Control Arm | No intervention | –Participants will watch a control video discussing daily activities. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Essential worker
- Ages 18-35
- English-speaking, able to provide consent
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 |
|---|---|---|
| Adjusted Content Intervention2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, using language that speaks to the specific experience of being a young Latina woman | Other | Adjusted Content Intervention Video |
| Non-Adjusted Intervention Video2-3-minute video in which an empowered essential worker protagonist shares her COVID-19 related mental health problems and describes how she was able to confront her mental health problems and pursuit of mental health care, without any language alluding to her particular identity characteristics | Other | Non-Adjusted Intervention Video |
Primary outcome
Stigma (the Self Stigma of Seeking Help Scale - 3 item) (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: 30 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 Attitudes Toward Seeking Professional Psychological Help) (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: 30 days after the intervention
Change in treatment seeking intentions from baseline - higher score, indicate higher help seeking intentions (range of 3 to 12)
1 secondary outcome
Number of Referral Clicks
Time frame: Immediately 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 18 Dec 2024.
- Derived from this study: PubMed 41159853Fisch CT, Lazarov A, Lewis-Fernandez R, Dixon LB, Neria Y, Amsalem D. Brief Video Intervention to Increase Treatment-Seeking Intentions Among Young Adults With Psychiatric Symptoms: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Oct 27;86(4):25m15881. doi: 10.4088/JCP.25m15881.
- Individual participant dataSharing planned: No. No identifying data of participants will be shared
Related trials for Stigma, Social
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
Substance Use Disorder
Recruiting
Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
Stigma, HIV
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 Adjusted Content Intervention and Non-Adjusted Intervention Video 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 3 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 18 Dec 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?
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 Self Stigma of Seeking Help Scale - 3 item) (SSOSH-3) (time frame: immediately after the intervention). The study lists 4 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 NCT05826132, 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 18 Dec 2024.