Clinician Supported Mobile App to Reduce Mental Health Symptoms Among World Trade Center Responders in Florida
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
This study examines mental health challenges among World Trade Center (WTC) General Responders, who continue to experience significant psychological trauma from the WTC collapse. PTSD and depression remain common, and nearly six percent of the WTC Health Program (WTCHP) cohort now resides in Florida. Many identify as Hispanic, underscoring the need for linguistically appropriate services. Research shows that remotely delivered, clinician-supported mobile applications can reduce mental health symptoms.
PTSD Coach, developed by the Veterans Administration, is a free self-managed mobile app designed to help users manage PTSD symptoms through tools such as relaxation exercises, calming self-talk, and sleep hygiene practices. Reviews of the app have found it feasible, acceptable, and effective in reducing PTSD symptoms.
Clinician-Supported PTSD Coach was designed for individuals unlikely to use the app independently. This model pairs the PTSD Coach app with four remote 20-30-minute clinician sessions over eight weeks. Studies with Veterans demonstrate reductions in PTSD and depression, higher satisfaction, and increased treatment engagement compared with usual care. However, these interventions have not yet been tested with WTC General Responders or Hispanic populations.
This study will evaluate the feasibility, acceptability, and effectiveness of Clinician-Supported PTSD Coach in reducing PTSD, depression, anxiety, and sleep disturbances among English- and Spanish-speaking WTC General Responders in Florida. Participants will be randomly assigned to one of three conditions: (1) Clinician-Supported PTSD Coach, (2) Self-Managed PTSD Coach, or (3) Waitlist Control. Assessments at 8 and 12 weeks will measure symptom reductions and examine engagement, satisfaction, and barriers within the app-based conditions. It is expected that both interventions will reduce symptoms, with greater improvements in the clinician-supported condition.
This project addresses a critical gap in evidence-based mental health treatments for dispersed WTC Responders and responds to the WTCHP Scientific/Technical Advisory Committee's call for more research on mental health interventions. By focusing on Hispanic and Spanish-speaking Responders-an understudied group-this study may support the development of scalable, app-based interventions that can be deployed nationally to meet the mental health needs of WTC responders and survivors.
详细描述
INTRODUCTION, BACKGROUND AND SIGNIFICANCE. The September 11, 2001 terrorist attacks on the World Trade Center (WTC) have had long-lasting impacts on the mental health of responders involved in rescue and recovery efforts. The World Trade Center Health Program (WTCHP) was established to monitor and treat health conditions related to the WTC disaster. This study addresses the mental health (MH) treatment needs of WTC responders, particularly those who have relocated to Florida after retirement and now represent an older WTCHP subgroup with a higher percentage of Latinos. The research evaluates a clinician-supported mobile application, Clinician Supported (CS) PTSD Coach, for reducing symptoms of Post-Traumatic Stress Disorder (PTSD), depression, anxiety, and sleep disturbances. The study also emphasizes inclusion of Spanish-speaking Hispanic responders to advance health equity through use of the Spanish version of the app and a Spanish adaptation of the intervention manual.
Background. Since its inception in 2011, the WTCHP, funded by CDC/NIOSH, has monitored and treated more than 120,000 responders and survivors with WTC-related conditions. Mental health conditions such as PTSD, anxiety, depression, substance abuse, and sleep disturbances are highly prevalent. PTSD is the most commonly certified psychiatric condition, with prevalence ranging from 3.8% to 29.6%. Despite the chronic nature of these conditions, there are few controlled studies of effective treatments. Most existing interventions are in-person and focus on highly exposed individuals. There have been virtually no controlled studies of app-based remote interventions for the large number of General Responders (GRs) with full or subthreshold PTSD, and none have focused on Spanish-speaking Hispanic GRs. This study addresses these gaps by testing a clinician-supported MH mobile application (CS PTSD Coach) among WTC GRs.
Florida Sub-Cohort. Florida has more than 5,496 registered WTC responders. This group is older, more often retired, and includes a higher proportion of Hispanic individuals compared with responders in other regions. The study focuses on this sub-cohort because of its unique vulnerabilities, including exposure to extreme climate events such as hurricanes that may exacerbate PTSD symptoms. Relocation of WTC responders from the New York Metropolitan Area to Florida is part of a broader migration trend, resulting in a growing number of WTCHP members in Florida and an urgent need for accessible MH services.
Preliminary data indicate that approximately 40% of Florida WTC responders show probable PTSD. There is interest in remotely delivered MH services, supporting the feasibility of the proposed intervention. The older age, higher retirement rates, and larger proportion of Hispanic individuals make this sub-cohort particularly relevant for studying the long-term MH effects of 9/11 exposure and the overlapping impact of aging.
Clinician Supported PTSD Coach Mobile App. The Clinician Supported (CS) PTSD Coach combines the self-managed PTSD Coach app with four 20-30 minute psychotherapy sessions delivered by a clinician over eight weeks. The app includes modules on psychoeducation about PTSD, self-assessment, symptom management, and accessing support. Preliminary studies with Veterans show that CS PTSD Coach can reduce PTSD and depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •World Trade Center General Responders (GRs) currently living in Florida.
- •Must have a smartphone device capable of using the PTSD Coach app.
- •Must be fluent in either English or Spanish.
排除标准
- •Active or recent (past month) suicidal ideation or attempt.
- •Low levels of distress as measured by the PCL-5 (score below 27).
- •Severe alcohol use measured by an AUDIT score of 20 or above.
- •Use of illicit or unprescribed drugs (except for cannabis) in the last 2 weeks, as indicated on the Modified ASSIST Measure.
- •Presence of neurologic or neurodegenerative conditions associated with significant cognitive impairment (e.g., Parkinson's, Alzheimer's diseases) or current severe cognitive impairment measured using the Montreal Cognitive Assessment (MoCA).
- •Current mental health treatment for PTSD.
研究组 & 干预措施
Clinician Supported PTSD Coach
PTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.
干预措施: Clinician Supported PTSD Coach (Behavioral)
Self Managed PTSD Coach application
Participant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support
干预措施: Self Managed PTSD Coach (Behavioral)
Wait list control
No intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Evaluate changes in PTSD symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
A self-report measure used to assess the presence and severity of PTSD symptoms. It consists of 20 items that correspond to the DSM-5 criteria for PTSD.
次要结局
- Patient Health Questionnaire-9 (PHQ-9).(Evaluate changes in depression symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).)
- Generalized Anxiety Disorder-7 (GAD-7)(Evaluate changes in anxiety symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).)
- Insomnia Severity Index (ISI)(Evaluate changes in sleep disturbance symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).)
