An interventional study of Clinician Supported PTSD Coach and Self Managed PTSD Coach in PTSD Symptoms, Anxiety Symptoms and Depression Symptoms, sponsored by Florida International University. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Florida International University · Not applicable, Interventional, and Treatment
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Among 3,709 studies in Depression with a site in United States — 578 open to participants now, 717 under way, 30 of them phase 3. Depression · United States.
Among the 3,709 studies in Depression with a site in United States, this one is the 1,179th largest by planned enrollment of the 3,316 interventional ones that give a count, is one of 207 that started in 2025, is one of 2,215 with no phase, reaches primary completion later than 246 of the 715 other live ones, and was the 3,335th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →578 of the 3,709 studies in Depression with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
NeuroRx, Inc. · Sites in United States
Ages 18–80
Ohio State University · Sites in United States
Ages 21–65
Florida State University · Sites in United States
Ages 18–55 · Healthy volunteers
University of Texas Southwestern Medical Center · Sites in United States
Ages 12–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,709 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 235 · Phase 2 441 · Phase 3 285 · Phase 4 265
First in 1977; this study’s year is marked. 207 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 72 across the 3,316 interventional studies, 138 across the 371 observational. Of the 2,761 that completed or were terminated, 1,045 (38%) have results posted.
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392 of 3,709 have an industry lead sponsor. The 10 most frequent:
Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Florida International University has 5 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Add all 299 to your calendar (.ics) → With an account.
Among the 3,709 studies in Depression with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
CS PTSD Coach was originally developed as a brief intervention for Veteran primary care patients with elevated PTSD symptoms who were unlikely to use a mobile app on their own. The clinician sessions provide instructions for app use, help set symptom-reduction goals, assign PTSD Coach activities between sessions, and assist participants in selecting and integrating app-based management strategies into daily life.
PTSD Coach is available at no cost from iTunes and Google Play and is accessible to nearly all U.S. smartphone users. The app is available in English and Spanish, making it suitable for the diverse WTC responder population. Its primary focus is PTSD symptom clusters: re-experiencing, persistent avoidance, negative thoughts or feelings, and hyperarousal (including sleep disturbance, startle, and irritability). The app provides psychoeducation on trauma and PTSD, symptom monitoring, and cognitive-behavioral coping tools such as relaxation exercises, calming self-talk, anger management, and sleep hygiene strategies. It has also shown benefits for depression and anxiety, which frequently co-occur with PTSD.
Significance.
The study is significant for several reasons:
SPECIFIC AIMS. This study will assess the feasibility, acceptability, and efficacy of the PTSD Coach app among a multi-ethnic group of 9/11 GRs in Florida, focusing on two app delivery models: clinician-supported (CS) and self-managed (SM). There are four aims.
Aim 1 evaluates engagement with the app by analyzing usage data (frequency and duration of interactions and module use) by language group (English and Spanish) and collecting feedback on usability, barriers, and suggestions.
Aim 2 evaluates acceptability by examining user satisfaction and other indicators of positive responses to the app. Feedback on treatment acceptability and appropriateness will be gathered using standardized measures.
Aim 3 assesses the efficacy of CS and SM PTSD Coach in a randomized controlled trial (RCT). The primary outcome is reduction in PTSD symptoms; secondary outcomes are reductions in depression, anxiety, and sleep disturbances. CS and SM groups will be compared with a wait-list control to evaluate symptom changes post-intervention and at follow-up, to test whether CS is more effective than SM, and to explore potential moderators and mediators of treatment effects.
Aim 4 develops and delivers a Spanish-language version of CS PTSD Coach and evaluates its feasibility, acceptability, and efficacy for Spanish-speaking participants.
METHODS. Study Design. This two-year project is a three-arm randomized clinical trial (RCT) with: (1) CS PTSD Coach, in which participants receive clinician-supported use of the app focused on app navigation, symptom monitoring, and management strategies; (2) SM PTSD Coach, in which participants receive basic instructions on app use but no ongoing clinician support; and (3) Wait-list Control, in which participants receive no intervention until after follow-up, when they may choose CS or SM PTSD Coach. Participants will be assessed at baseline, immediately post-intervention at four weeks, and again four weeks later. Outcomes are feasibility, acceptability, and efficacy of PTSD Coach for reducing MH symptoms among WTC responders.
Recruitment and Randomization. Recruitment will use existing WTCHP General Responders Data Center resources and networks. Participants will be randomly assigned to one of the three conditions using a random number generator. The target sample is 120 participants, enrolled on a rolling basis to achieve sufficient sample size.
Measures and Data Collection. Validated measures will assess PTSD, depression, anxiety, and sleep disturbance symptoms. Data will be collected at multiple time points to evaluate symptom change and overall intervention effectiveness.
Analyses. Continuous data will be summarized with means and standard deviations or, when skewed, medians and interquartile ranges (IQRs). Categorical data will be summarized with frequencies (N) and percentages (%).
Feasibility will be assessed using objective app-use data to quantify frequency and duration of interactions and feature use, examine usage patterns (including peak engagement times and trends) by group and language, and identify the most frequently used modules. Usability will be assessed with the SUS to determine whether "good" usability is achieved.
Acceptability will be evaluated by analyzing satisfaction with PTSD Coach in both conditions and by language using the CSQ. Items rated as "good" or "excellent" will indicate endorsement. Additional feedback on acceptability of CS PTSD Coach will be collected using the AIM and IAM; items rated as "agree" or "completely agree" will indicate endorsement.
Efficacy of CS PTSD Coach will be examined using several approaches. Paired t-tests will test within-condition changes in psychological symptoms, reporting pre- and post-intervention means and standard deviations. Analysis of Covariance (ANCOVA) will compare changes in symptom scores across CS PTSD Coach, SM PTSD Coach, and wait-list control, adjusting for baseline scores and other covariates. Sample size calculations indicate that 40 participants per group, allowing for 10% attrition, will provide 80% power to detect differences between conditions.
An intent-to-treat analysis will include all randomized participants regardless of intervention completion. Missing data will be addressed using multiple imputation to maintain robustness and reduce bias.
Moderation and mediation analyses will further clarify intervention effects. Moderators (baseline PTSD severity, sex, race, ethnicity, and language [English vs. Spanish]) will be examined via interaction terms in ANCOVA models. Mediation analyses will follow the Baron and Kenny framework, using product-of-coefficients tests to assess whether intervention effects on PTSD symptoms are mediated by other variables.
EXPECTED IMPACT AND CONCLUSION. This study addresses critical gaps in MH treatment research for WTC responders, particularly those in Florida. By testing a remote, clinician-supported intervention, it has the potential to improve access to MH care for a geographically dispersed and ethnically diverse population. Findings may inform future research and clinical practice and enhance the well-being of WTC responders.
By leveraging innovative technology and focusing on an underserved population, this study aims to provide effective, accessible, and equitable MH care. The results will have important implications for the broader WTCHP cohort and contribute to ongoing efforts to support those affected by the 9/11 attacks.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's planned enrollment of 120 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.
Behavioral: Clinician Supported PTSD Coach
Participant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support
Behavioral: Self Managed PTSD Coach
No intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.
Combines self-managed PTSD Coach application with four 20-30 minute sessions delivered by a clinician. The app includes modules on learning about PTSD, self-assessment, symptom management, and finding support.
A widely available mobile application designed to help individuals manage PTSD symptoms available in English and Spanish.
PTSD Checklist for DSM-5 (PCL-5)
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.
Time frame: Evaluate changes in PTSD symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Patient Health Questionnaire-9 (PHQ-9).
Self-report measure that consists of 9 items. Each item corresponds to one of the DSM-5 criteria for depression and is rated on a scale from 0 (not at all) to 3 (nearly every day), based on how often the respondent has been bothered by that symptom over the past two weeks.
Time frame: 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)
self-report questionnaire that consists of 7 items, each corresponding to a symptom of generalized anxiety disorder. Respondents rate how often they have been bothered by each symptom over the past two weeks on a scale from 0 (not at all) to 3 (nearly every day)
Time frame: Evaluate changes in anxiety symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Insomnia Severity Index (ISI)
7-item self-report questionnaire that evaluates the severity of insomnia symptoms over the past two weeks. Each item is rated on a scale from 0 (no problem) to 4 (very severe problem)
Time frame: Evaluate changes in sleep disturbance symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Plan to share: No — Protecting the privacy of these World Trade Center General Responders is paramount. Sharing IPD could risk exposing sensitive personal information, even if anonymized, which might lead to re-identification.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Florida International University →