AnxietyNCT06316804
Mobile Mental Health Stigma Reduction Intervention Among Black Adults
A study testing Video Intervention 1, Video Intervention 2 and Video Intervention 3 in people with Anxiety and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anxiety, Depression, Health Knowledge, Attitudes, Practice
- What is being tested?
- Video Intervention 1, Video Intervention 2 and Video Intervention 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- If you identify as Black American or Black immigrant
- Experience or been diagnosed with depression and/or anxiety
- Age 18-45 years
- Own a smartphone with internet access
- Have not seen a psychiatrist or therapist in the last 12 months or have not been in routine healthcare
- English speaking
Who cannot join
- Visual, hearing, voice, or motor impairments that would prevent engagement in study procedures,
- Diagnosis of psychotic disorder or severe suicidality for which participation would be inappropriate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Design and Feasibility of a Mobile Mental Health Stigma Reduction Intervention Among Black Adults With Depression and Anxiety
Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety.
Read the detailed description
Major depressive and anxiety disorders affect 57.3 million adults in the U.S. These disorders are also highly stigmatized. Stigma refers to negative attitudes or beliefs about mental illness, or negative behaviors directed toward persons with mental illness (PWMI) is a leading and fundamental cause of health inequities.
The efficacy and precision of anti- stigma interventions to improve mental health outcomes among underserved Black adults are grossly limited and represent a critical public health gap. Studies show stigma compounds disabilities related to the primary symptoms of mental illness and increases morbidity and premature mortality related to mental illness. Compared with white adults, Black adults with mental illness have more chronic disease, and more severe illness at presentation. Meta-analyses have consistently shown that both face-to-face and video-based contact with individuals with mental illness can reduce stigma. Recent studies that distinguished contact delivery showed effect size for video-based contact to be comparable to face-to-face contact. Contact interventions, which are premised on the idea that positive and voluntary contact with PWMI can effectively reduce mental illness stigma, are aimed at reducing stigma and improving health outcomes.
The primary objective of this study is to evaluate the efficacy of a self-administered, video-based mobile app intervention aimed at reducing mental illness stigma among Black adults. Black adults with moderate to severe depression or anxiety will be recruited to participate in the Randomized Controlled Trial (RCT). Participants will be randomly assigned to one of three arms: two video-based intervention arms and one waitlist control arm. The video-based intervention will include first-hand lived experience stories of mental health and one's recovery journey.
- Conditions
- Anxiety, Depression, Health Knowledge, Attitudes, Practice, Stigmatization, Mobile Phone Use
- Being tested
- Video Intervention 1, Video Intervention 2, Video Intervention 3
- Keywords
- Stigma, Digital Mental Health, Community Engaged Research, Black Adult, Mobile Health
- Medical subject headings
- Anxiety Disorders, Depression, Behavior, Stereotyping, Cell Phone Use, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Intervention 1Behavioural
A self-administered video-based mobile app with narratives on mental illness. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety.
Video Intervention 2Behavioural
A self-administered video-based mobile app with narratives on mental illness. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety.
Video Intervention 3Behavioural
An experimental self-administered video-based mobile app with narratives on mental illness after the waitlist period has been completed. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Video Intervention 1 | Experimental | The video intervention #1 will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). Assessments will be completed over 12 months from date of randomization. Receives: Behavioral: Video Intervention 1 |
| Video Intervention 2 | Active comparator | The video intervention #2 will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). Assessments will be completed over 12 months from date of randomization. Receives: Behavioral: Video Intervention 2 |
| Waitlist Video Intervention 3 | Placebo comparator | After the completion of the 6-month waitlist period, the experimental video intervention will be provided. The intervention will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). The intervention offered after the waitlist period will follow video intervention 1 (experimental arm). Receives: Behavioral: Video Intervention 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Inventory of Costs in Patients with Psychiatric Disorders
An adapted version to evaluate the utilization of mental health care services. The self-report questionnaire includes single item questions that will be used such as, "How many appointments have you attended at a Mental Health Care Institution in the past 3 months? Or at another mental health treatment facility?" and "In the past 3 months, how many appointments have you had with a psychologist, psychotherapist, or psychiatrist at a hospital?". Response options are qualitative: "no appointments" or providing the number of appointments attended. The test-retest reliability based on Cohen's Kappa was 0.649. Construct validity was assessed through the number of contacts recorded in the registration data, with a high correlation (ρ = 0.791).
Measured: 12 months post intervention
Release of Information Form
The release of information form will be used to objectively measure the utilization of mental healthcare services by identifying visits made to these services. More or less visits is dependent on patient needs and does not have an intrinsic positive or negative value.
Measured: 12 months post intervention
Secondary outcomes (4)
Reported and Intended Behavior Scale
The Reported and Intended Behavior Scale includes 4 questions on each of the reported and intended behaviors. Items 1-4 are binary, "yes" or "no". Items 5-8 are evaluated using a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from a minimum of 4 to a maximum of 20. Higher scores indicate less stigma (less desire for social distance) and lower scores indicate higher stigma (more desire for social distance). The test-retest reliability was 0.75, and internal consistency, based on Cronbach's alpha among items 5-8, was 0.85.
Measured: Pre-intervention and up to 12 months post-intervention
Internalized Stigma of Mental Illness
The Internalized Stigma of Mental Illness is a 29-item measure with subscales that assess enacted and internalized stigma. Each item is evaluated using a four-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from a minimum of 29 to a maximum of 116. The higher scores indicate more internalized stigma. The original Internalized Stigma of Mental Illness reported test-retest reliability of 0.92.
Measured: Pre-intervention and up to 12 months post-intervention
The Group Based Medical Mistrust Scale
The Group Based Medical Mistrust Scale is a 12 -item scale to measure race-based medical mistrust; it has strong validity and reliability. Each item is evaluated using a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from a minimum of 12 to a maximum of 60. Higher scores indicate greater medical mistrust.The Cronbach alpha for the full measure in previous studies was α=0.87-0.88. The total score and its three subscales were positively correlated with avoidance of health care (total score: p<0.0001; r=0.344).
Measured: Pre-intervention and up to 12 months post-intervention
Group Help Seeking Questionnaire
The Group Help Seeking Questionnaire contains 10-items repeated for two problems (personal emotional and suicidal emotions). Each item is evaluated using a seven-point Likert scale, ranging from 1 (extremely unlikely) to 7 (extremely likely). The total score ranges from a minimum of 20 to a maximum of 140. Higher scores indicate higher help seeking intentions. Cronbach alpha for the full measure in previous studies was α=0.91. The perceived quality of previous mental health care was positively related to intentions to seek help from a mental health professional for personal-emotional problems, rs(55) = 0.51, p < 0.001, and suicidal thoughts, rs(54) = 0.57, p < 0.001.
Measured: Pre-intervention and up to 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three intervention arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aderonke Bamgbose Pederson, Massachusetts General Hospital
- Investigators
- Aderonke Pederson, MD, Principal investigator, Massachuessets General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316804
- Sponsor's protocol ID
- 2022P000580
- Other IDs
- 1K23MH128535-01A1, 5K23MH128535-04, 5K23MH128535-03, 5K23MH128535-02
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, Hakkaart-van Roijen L. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013 Jun 15;13:217. doi: 10.1186/1472-6963-13-217.
PubMed 23768141Boyd JE, Adler EP, Otilingam PG, Peters T. Internalized Stigma of Mental Illness (ISMI) scale: a multinational review. Compr Psychiatry. 2014 Jan;55(1):221-31. doi: 10.1016/j.comppsych.2013.06.005. Epub 2013 Sep 21.
PubMed 24060237Evans-Lacko S, Rose D, Little K, Flach C, Rhydderch D, Henderson C, Thornicroft G. Development and psychometric properties of the reported and intended behaviour scale (RIBS): a stigma-related behaviour measure. Epidemiol Psychiatr Sci. 2011 Sep;20(3):263-71. doi: 10.1017/s2045796011000308.
PubMed 21922969Ibrahim N, Amit N, Shahar S, Wee LH, Ismail R, Khairuddin R, Siau CS, Safien AM. Do depression literacy, mental illness beliefs and stigma influence mental health help-seeking attitude? A cross-sectional study of secondary school and university students from B40 households in Malaysia. BMC Public Health. 2019 Jun 13;19(Suppl 4):544. doi: 10.1186/s12889-019-6862-6.
PubMed 31196033Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004 Feb;38(2):209-18. doi: 10.1016/j.ypmed.2003.09.041.
PubMed 14715214Pederson AB. An mHealth App to Increase Engagement in Mental Health Services for Depression and Anxiety: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 28;15:e81645. doi: 10.2196/81645.
PubMed 42061858
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Feasibility of a Mobile Mental Health Stigma Reduction Intervention Among Black Adults With Depression and Anxiety
- ClinicalTrials.gov ID
- NCT06316804
- Acronym / sponsor ID
- 2022P000580
- Conditions
- Anxiety, Depression, Health Knowledge, Attitudes, Practice, Stigmatization, Mobile Phone Use
- Keywords
- Stigma, Digital Mental Health, Community Engaged Research, Black Adult, Mobile Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Mar 2024 (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.
Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety.
Detailed description
Major depressive and anxiety disorders affect 57.3 million adults in the U.S. These disorders are also highly stigmatized. Stigma refers to negative attitudes or beliefs about mental illness, or negative behaviors directed toward persons with mental illness (PWMI) is a leading and fundamental cause of health inequities.
The efficacy and precision of anti- stigma interventions to improve mental health outcomes among underserved Black adults are grossly limited and represent a critical public health gap. Studies show stigma compounds disabilities related to the primary symptoms of mental illness and increases morbidity and premature mortality related to mental illness. Compared with white adults, Black adults with mental illness have more chronic disease, and more severe illness at presentation. Meta-analyses have consistently shown that both face-to-face and video-based contact with individuals with mental illness can reduce stigma. Recent studies that distinguished contact delivery showed effect size for video-based contact to be comparable to face-to-face contact. Contact interventions, which are premised on the idea that positive and voluntary contact with PWMI can effectively reduce mental illness stigma, are aimed at reducing stigma and improving health outcomes.
The primary objective of this study is to evaluate the efficacy of a self-administered, video-based mobile app intervention aimed at reducing mental illness stigma among Black adults. Black adults with moderate to severe depression or anxiety will be recruited to participate in the Randomized Controlled Trial (RCT). Participants will be randomly assigned to one of three arms: two video-based intervention arms and one waitlist control arm. The video-based intervention will include first-hand lived experience stories of mental health and one's recovery journey.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Video Intervention 1 | Experimental | Behavioral: Video Intervention 1The video intervention #1 will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). Assessments will be completed over 12 months from date of randomization. |
| Video Intervention 2 | Active comparator | Behavioral: Video Intervention 2The video intervention #2 will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). Assessments will be completed over 12 months from date of randomization. |
| Waitlist Video Intervention 3 | Placebo comparator | Behavioral: Video Intervention 3After the completion of the 6-month waitlist period, the experimental video intervention will be provided. The intervention will involve videos of patients describing personal narratives of mental illness, treatment and recovery, and will be delivered over 4 weeks (with two booster sessions in week 6 and 12). The intervention offered after the waitlist period will follow video intervention 1 (experimental arm). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- If you identify as Black American or Black immigrant
- Experience or been diagnosed with depression and/or anxiety
- Age 18-45 years
- Own a smartphone with internet access
- Have not seen a psychiatrist or therapist in the last 12 months or have not been in routine healthcare
Key exclusion criteria (2 listed)
- Visual, hearing, voice, or motor impairments that would prevent engagement in study procedures,
- Diagnosis of psychotic disorder or severe suicidality for which participation would be inappropriate.
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 Intervention 1A self-administered video-based mobile app with narratives on mental illness. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety. | Behavioural | Video Intervention 1 |
| Video Intervention 2A self-administered video-based mobile app with narratives on mental illness. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety. | Behavioural | Video Intervention 2 |
| Video Intervention 3An experimental self-administered video-based mobile app with narratives on mental illness after the waitlist period has been completed. The content of the videos consists of individuals sharing their personal experiences with depression and anxiety. | Behavioural | Waitlist Video Intervention 3 |
Primary outcome
Treatment Inventory of Costs in Patients with Psychiatric Disorders
Time frame: 12 months post intervention
An adapted version to evaluate the utilization of mental health care services. The self-report questionnaire includes single item questions that will be used such as, "How many appointments have you attended at a Mental Health Care Institution in the past 3 months? Or at another mental health treatment facility?" and "In the past 3 months, how many appointments have you had with a psychologist, psychotherapist, or psychiatrist at a hospital?". Response options are qualitative: "no appointments" or providing the number of appointments attended. The test-retest reliability based on Cohen's Kappa was 0.649. Construct validity was assessed through the number of contacts recorded in the registration data, with a high correlation (ρ = 0.791).
Release of Information Form
Time frame: 12 months post intervention
The release of information form will be used to objectively measure the utilization of mental healthcare services by identifying visits made to these services. More or less visits is dependent on patient needs and does not have an intrinsic positive or negative value.
4 secondary outcomes
Reported and Intended Behavior Scale
Time frame: Pre-intervention and up to 12 months post-intervention
Internalized Stigma of Mental Illness
Time frame: Pre-intervention and up to 12 months post-intervention
The Group Based Medical Mistrust Scale
Time frame: Pre-intervention and up to 12 months post-intervention
Group Help Seeking Questionnaire
Time frame: Pre-intervention and up to 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 23768141Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, Hakkaart-van Roijen L. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013 Jun 15;13:217. doi: 10.1186/1472-6963-13-217.
- Background: PubMed 24060237Boyd JE, Adler EP, Otilingam PG, Peters T. Internalized Stigma of Mental Illness (ISMI) scale: a multinational review. Compr Psychiatry. 2014 Jan;55(1):221-31. doi: 10.1016/j.comppsych.2013.06.005. Epub 2013 Sep 21.
- Background: PubMed 21922969Evans-Lacko S, Rose D, Little K, Flach C, Rhydderch D, Henderson C, Thornicroft G. Development and psychometric properties of the reported and intended behaviour scale (RIBS): a stigma-related behaviour measure. Epidemiol Psychiatr Sci. 2011 Sep;20(3):263-71. doi: 10.1017/s2045796011000308.
- Background: PubMed 31196033Ibrahim N, Amit N, Shahar S, Wee LH, Ismail R, Khairuddin R, Siau CS, Safien AM. Do depression literacy, mental illness beliefs and stigma influence mental health help-seeking attitude? A cross-sectional study of secondary school and university students from B40 households in Malaysia. BMC Public Health. 2019 Jun 13;19(Suppl 4):544. doi: 10.1186/s12889-019-6862-6.
- Background: PubMed 14715214Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004 Feb;38(2):209-18. doi: 10.1016/j.ypmed.2003.09.041.
- Derived from this study: PubMed 42061858Pederson AB. An mHealth App to Increase Engagement in Mental Health Services for Depression and Anxiety: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 28;15:e81645. doi: 10.2196/81645.
- Individual participant dataSharing planned: No
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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.
Aderonke Pederson, MD principal investigator
Massachuessets General Hospital
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 Intervention 1, Video Intervention 2 and Video Intervention 3 in people with Anxiety and Depression, run by Massachusetts General Hospital 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Treatment Inventory of Costs in Patients with Psychiatric Disorders (time frame: 12 months post intervention). The study lists 2 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 NCT06316804, which also lists 6 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 11 Aug 2026.