Mobile Mental Health Stigma Reduction Intervention Among Black Adults

Depression Clinical Trial

Official title:

Design and Feasibility of a Mobile Mental Health Stigma Reduction Intervention Among Black Adults With Depression and Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316804
• Other study ID #: 2022P000580
• Secondary ID: 1K23MH128535-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Aderonke Pederson, MD
• Phone: 617 724 4587
• Email: apederson[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (? = 0.791).	12 months post intervention
Primary	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	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.	Pre-intervention and up to 12 months post-intervention
Secondary	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.	Pre-intervention and up to 12 months post-intervention
Secondary	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 a=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).	Pre-intervention and up to 12 months post-intervention
Secondary	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 a=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.	Pre-intervention and up to 12 months post-intervention