Mobile Mental Health Stigma Reduction Intervention Among Black Adults

NCT06316804 | Active Not Recruiting

• 2 other identifiers: 2022P0005801K23MH128535-01A1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Stigma; Digital Mental Health; Community Engaged Research; Black Adult; Mobile Health

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  12 months post intervention

Secondary Outcomes (4)

• Reported and Intended Behavior Scale

  Pre-intervention and up to 12 months post-intervention

• Internalized Stigma of Mental Illness

  Pre-intervention and up to 12 months post-intervention

• The Group Based Medical Mistrust Scale

  Pre-intervention and up to 12 months post-intervention

• Group Help Seeking Questionnaire

  Pre-intervention and up to 12 months post-intervention

Study Arms (3)

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.

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.

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).

Behavioral: Video Intervention 3

Interventions

Video Intervention 1 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 1

Video Intervention 2 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

Video Intervention 3 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.

Waitlist Video Intervention 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• 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.

  PMID: 23768141 BACKGROUND

• 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.

  PMID: 24060237 BACKGROUND

• 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.

  PMID: 21922969 BACKGROUND

• 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.

  PMID: 31196033 BACKGROUND

• 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.

  PMID: 14715214 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Behavior; Stereotyping; Cell Phone Use; Social Stigma

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Social Behavior; Communication

Study Officials

• Aderonke Pederson, MD

  Massachuessets General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Participants will be randomly assigned to one of three intervention arms.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)