Clinical trial NCT06316804: Mobile Mental Health Stigma Reduction Intervention Among Black Adults
Official title: Design and Feasibility of a Mobile Mental Health Stigma Reduction Intervention Among Black Adults With Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Health Knowledge, Attitudes, Practice
Stigmatization
Mobile Phone Use
Keywords: Stigma
Digital Mental Health
Community Engaged Research
Black Adult
Mobile Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-03-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three intervention arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Inventory of Costs in Patients with Psychiatric Disorders
timeFrame: 12 months post intervention
measure: Release of Information Form
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Reported and Intended Behavior Scale
timeFrame: Pre-intervention and up to 12 months post-intervention
measure: Internalized Stigma of Mental Illness
timeFrame: Pre-intervention and up to 12 months post-intervention
measure: The Group Based Medical Mistrust Scale
timeFrame: Pre-intervention and up to 12 months post-intervention
measure: Group Help Seeking Questionnaire
timeFrame: Pre-intervention and up to 12 months post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachuessets General Hospital
name: Aderonke Pederson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.