Design and Feasibility of a Mobile Mental Health Stigma Reduction Intervention Among Black Adults With Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Treatment Inventory of Costs in Patients with Psychiatric Disorders
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Video Intervention 1 (Behavioral)
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.
干预措施: Video Intervention 2 (Behavioral)
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).
干预措施: Video Intervention 3 (Behavioral)
结局指标
主要结局
Treatment Inventory of Costs in Patients with Psychiatric Disorders
时间窗: 12 months post intervention
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).
Release of Information Form
时间窗: 12 months post intervention
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.
次要结局
- Reported and Intended Behavior Scale(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)
- Internalized Stigma of Mental Illness(Pre-intervention and up to 12 months post-intervention)
研究者
Aderonke Bamgbose Pederson
Physician
Massachusetts General Hospital