Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors
Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors
2 other identifiers
interventional
105
1 country
4
Brief Summary
If you worked or volunteered as a WTC rescue, recovery or clean-up worker after the 9/11 attacks, or are a survivor of the WTC 9/11 attacks, and you are still experiencing Posttraumatic Stress Disorder (PTSD) symptoms related to your WTC experience, you might be eligible to participate in this clinical trial of therapist-assisted, Internet-based (online) writing therapy for WTC responders and survivors with persistent PTSD symptoms. This study is for WTC responders and survivors who are not currently receiving psychotherapy/counseling. In this study, the researchers aim to find out if Internet-based therapy can help WTC responders and survivors who are still experiencing PTSD symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedJanuary 25, 2022
January 1, 2022
3.7 years
May 12, 2017
January 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD symptom change on the PTSD Checklist for DSM-5
WTC-related PTSD symptoms, assessed using total PTSD Checklist-5 (PCL-5) score. PCL-5 scores range from 0-80, with higher score indicating more severe PTSD symptoms.
Pre- to Post-treatment, average 9 weeks
Secondary Outcomes (11)
Durability of PTSD symptom change on the PCL-5
3 months post-treatment
Change in PTSD symptom clusters on the PCL-5
Pre- to Post-treatment, average 9 weeks
Durability of change in PTSD symptom clusters on the PCL-5
3 months post-treatment
Beck Depression Inventory II (BDI-II)
Pre- to Post-treatment, average 9 weeks
Beck Depression Inventory II (BDI-II)
3 months post-treatment
- +6 more secondary outcomes
Study Arms (2)
Online Cognitive-Behavioral Therapy
EXPERIMENTALThrough guided writing, Internet-based cognitive therapy aims to help WTC responders and survivors process any traumatic experiences they lived through during their WTC recovery work and exposure.
Online Supportive Therapy
ACTIVE COMPARATORThrough guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing.
Interventions
Each participant will complete writing assignments focusing on how their experiences during the 9/11 attacks or the WTC recovery effort continue to affect their life, and the therapist will provide written responses and guidance within two work days, through the secure Web platform. Participants will be asked to complete one to two 45-minute writing assignments per week, over a six-week period (11 in total). Participants are asked not to begin new psychotherapy or medication with an outside therapist or doctor during the study.
Each participant will complete writing assignments focusing on problems and stressors that are currently affecting their life, and the therapist will provide written responses and guidance within two work days, through the secure Web platform. Participants will be asked to complete one to two 45-minute writing assignments per week, over a six-week period (11 in total). Participants are asked not to begin new psychotherapy or medication with an outside therapist or doctor during the study.
Eligibility Criteria
You may qualify if:
- Men and women who have worked or volunteered as rescue, recovery or clean-up workers at the WTC site following the 9/11 attacks, or who were living as a resident or working as an employee within the NYC disaster area during the 9/11 attacks, and who:
- are currently still experiencing significant posttraumatic stress symptoms related to what they witnessed or lived through during the 9/11 attacks or their WTC recovery work and:
- are not currently receiving psychotherapy or counseling
- do not have psychosis, a psychotic disorder, or bipolar disorder
- have not had recent alcohol or drug use problems
- are not experiencing suicidal thoughts,thoughts of harming others, or significant dissociative symptoms.
You may not qualify if:
- are currently taking antipsychotic medication, lithium or valproic acid.
- have a current uncontrolled medical illness, neurological disorder affecting the central nervous system, or history of head injury
- currently taking daily benzodiazepines or daily opioid medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Yale University
New Haven, Connecticut, 06520-8064, United States
Boston University
Boston, Massachusetts, 02215-1703, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
James J. Peters VA Medical Center
The Bronx, New York, 10468, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana Feder, MD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Robert H Pietrzak, PhD, MPH
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 16, 2017
Study Start
August 21, 2017
Primary Completion
May 20, 2021
Study Completion
August 10, 2021
Last Updated
January 25, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share