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Active, not recruitingNCT06316804Updated Aug 11, 2026

Mobile Mental Health Stigma Reduction Intervention Among Black Adults

An interventional study of Video Intervention 1 and Video Intervention 2 in Anxiety, Depression and Health Knowledge, Attitudes, Practice, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Anxiety
  • Depression
  • Health Knowledge, Attitudes, Practice
  • Stigmatization
  • Mobile Phone Use

Keywords

  • Stigma
  • Digital Mental Health
  • Community Engaged Research
  • Black Adult
  • Mobile Health
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 90 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. If you identify as Black American or Black immigrant
  2. Experience or been diagnosed with depression and/or anxiety
  3. Age 18-45 years
  4. Own a smartphone with internet access
  5. Have not seen a psychiatrist or therapist in the last 12 months or have not been in routine healthcare
  6. English speaking

Exclusion criteria

Exclusion Criteria:

  1. Visual, hearing, voice, or motor impairments that would prevent engagement in study procedures,
  2. Diagnosis of psychotic disorder or severe suicidality for which participation would be inappropriate.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Video Intervention 1

    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.

    Behavioral: Video Intervention 1

  • Active comparator
    Video Intervention 2

    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.

    Behavioral: Video Intervention 2

  • Placebo comparator
    Waitlist Video Intervention 3

    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).

    Behavioral: Video Intervention 3

Interventions

  • BehavioralVideo Intervention 1

    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.

  • BehavioralVideo Intervention 2

    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.

  • BehavioralVideo Intervention 3

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 months post intervention

  2. 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.

    Time frame: 12 months post intervention

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention and up to 12 months post-intervention

  2. 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.

    Time frame: Pre-intervention and up to 12 months post-intervention

  3. 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).

    Time frame: Pre-intervention and up to 12 months post-intervention

  4. 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.

    Time frame: Pre-intervention and up to 12 months post-intervention

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

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 23768141 ↗
  • Boyd 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 24060237 ↗
  • Evans-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 21922969 ↗
  • Ibrahim 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 31196033 ↗
  • Thompson 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 14715214 ↗
  • Pederson 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06316804
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Aderonke Bamgbose Pederson (Physician, Massachusetts General Hospital) — Principal investigator
First posted
Mar 18, 2024
Start date
Mar 15, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Aderonke Pederson, MD
principal investigator · Massachuessets General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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