Mobile Mental Health Stigma Reduction Intervention Among Black Adults

NCT ID: NCT06316804

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2027-07-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three intervention arms.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Random assignment to the 3 arms in a 1:1:1 allocation ratio will be determined centrally by the PI according to a random schedule. There is no practical way to blind the study participants to treatment and accomplish the objectives of the study. However, the study participants will be unaware of the aims of the arm to which they were assigned. Because they will not be blinded to the video exposure, the study participants assigned to one of the video contact arms will be aware that they are being exposed to a video-based contact intervention, and the study participants assigned to the waitlist control arm will be aware that they are being waitlisted. The research coordinator/team member (who will be conducting the outcome assessments) will be blinded to treatment assignment status.

Study Groups

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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.

Group Type EXPERIMENTAL

Video Intervention 1

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Video Intervention 2

Intervention Type BEHAVIORAL

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.

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).

Group Type PLACEBO_COMPARATOR

Video Intervention 3

Intervention Type BEHAVIORAL

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.

Interventions

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Video 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.

Intervention Type BEHAVIORAL

Video 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.

Intervention Type BEHAVIORAL

Video 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aderonke Bamgbose Pederson

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aderonke Pederson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachuessets General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aderonke Pederson, MD

Role: CONTACT

617 724 4587

Facility Contacts

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Aderonke Bamgbose Pederson, MD

Role: primary

617-724-4587

References

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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.

Reference Type BACKGROUND
PMID: 23768141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24060237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21922969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31196033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14715214 (View on PubMed)

Other Identifiers

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1K23MH128535-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P000580

Identifier Type: -

Identifier Source: org_study_id

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