Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors

January 8, 2022 updated by: Adriana Feder, Icahn School of Medicine at Mount Sinai

Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Some people who live through traumatic experiences, such as the 9/11 WTC attacks or their aftermath, suffer from mental and physical problems that occur as a result of the incident and can persist over time. These problems are known as post-traumatic stress reactions or symptoms, and may include sleep disturbances, feelings of guilt and shame, persistent nightmares or upsetting memories of the incident, avoidance of reminders that might trigger upsetting memories, loss of interest in activities, concentration difficulties, and feeling distant from other people.

People who experience persistent PTSD symptoms often receive treatment in person in an outpatient clinic. However, recent findings suggest that Internet-based treatment can also yield positive treatment effects. The Internet offers people the opportunity to receive psychological support from home. For some people, it is easier to communicate without direct visual contact with another person about their experiences. Despite the distance, people can reflect on their situation or concerns with the help of a personal therapist.

As mentioned above, this study is for WTC responders who are not currently receiving psychotherapy/ counseling. After completing the online consent form and an initial online questionnaire, participants complete a telephone assessment conducted by a member of the team at Mount Sinai Medical Center. If you are eligible and agree to participate, you will be randomly assigned (as by the flip of a coin) to receive one of two therapies: Internet-based cognitive-behavioral therapy or Internet-based supportive therapy. Each participant is assigned a personal therapist from the team at Mount Sinai to work with throughout the treatment. In this study, communication between participant and therapist is conducted exclusively across the Internet, in written form, through the secure Web platform housed at Mount Sinai. The treatment involves written exchanges between participant and therapist over the course of approximately six weeks. Through guided writing, online therapy aims to help WTC responders process their traumatic experiences or better manage current life problems. In this study, the researchers aim to find out if Internet-based therapy can help WTC responders who are still experiencing PTSD symptoms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8064
        • Yale University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-1703
        • Boston University
    • New York
      • Bronx, New York, United States, 10468
        • James J. Peters VA Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online Cognitive-Behavioral Therapy
Through 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.
Behavioral: Online Cognitive-Behavioral Therapy
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.
Other Names:
  • Online Therapist-assisted Cognitive-Behavioral Therapy
  • Integrative Testimonial Therapy
Active Comparator: Online Supportive Therapy
Through guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing.
Behavioral: Online Supportive Therapy
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.
Other Names:
  • Online Therapist-assisted Supportive Therapy
  • Modified Present-Centered Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PTSD symptom change on the PTSD Checklist for DSM-5
Time Frame: Pre- to Post-treatment, average 9 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Durability of PTSD symptom change on the PCL-5
Time Frame: 3 months post-treatment
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.
3 months post-treatment
Change in PTSD symptom clusters on the PCL-5
Time Frame: Pre- to Post-treatment, average 9 weeks
PTSD symptom dimensions (DSM-5 criteria B, C, D, and E), assessed using PCL-5 subscale scores. (B) Intrusion symptoms subscale scores range from 0-20, (C) Avoidance subscale scores range from 0-8, (D) Negative alterations in cognitions and mood subscale scores range from 0-28, and (E) Alterations in arousal and reactivity subscale scores range from 0-24).
Pre- to Post-treatment, average 9 weeks
Durability of change in PTSD symptom clusters on the PCL-5
Time Frame: 3 months post-treatment
PTSD symptom dimensions (DSM-5 criteria B, C, D, and E), assessed using PCL-5 subscale scores. (B) Intrusion symptoms subscale scores range from 0-20, (C) Avoidance subscale scores range from 0-8, (D) Negative alterations in cognitions and mood subscale scores range from 0-28, and (E) Alterations in arousal and reactivity subscale scores range from 0-24).
3 months post-treatment
Beck Depression Inventory II (BDI-II)
Time Frame: Pre- to Post-treatment, average 9 weeks
Beck Depression Inventory II (BDI-II) is a 21-item scale for measuring the severity of depression, each item scored 0 (not present) to 3 (severe) with total from 0 (minimal depression) to 63 (severe depression).
Pre- to Post-treatment, average 9 weeks
Beck Depression Inventory II (BDI-II)
Time Frame: 3 months post-treatment
Beck Depression Inventory II (BDI-II) is a 21-item scale for measuring the severity of depression, each item scored 0 (not present) to 3 (severe) with total from 0 (minimal depression) to 63 (severe depression).
3 months post-treatment
GAD-7
Time Frame: Pre- to Post-treatment, average 9 weeks
Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7 item scale for measuring the severity of anxiety, each item scored 0 (Not at all) to 3 (Nearly every day), with total from 0 (minimal anxiety) to 21 (severe anxiety).
Pre- to Post-treatment, average 9 weeks
GAD-7
Time Frame: 3 months post-treatment
Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7 item scale for measuring the severity of anxiety, each item scored 0 (Not at all) to 3 (Nearly every day), with total from 0 (minimal anxiety) to 21 (severe anxiety).
3 months post-treatment
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Time Frame: Pre- to Post-treatment, average 9 weeks
Psychological growth following a traumatic experience is assessed with the PTGI-SF. PTGI-SF is a 10-item scale for assessing positive outcomes reported by persons who have experienced traumatic events. Each item is scored 0 (did not experience) to 5 (experienced change to a great degree) with total from 0 (minimal change) to 50 (much change towards positive outcomes)
Pre- to Post-treatment, average 9 weeks
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Time Frame: 3 months post-treatment
Psychological growth following a traumatic experience is assessed with the PTGI-SF. PTGI-SF is a 10-item scale for assessing positive outcomes reported by persons who have experienced traumatic events. Each item is scored 0 (did not experience) to 5 (experienced change to a great degree) with total from 0 (minimal change) to 50 (much change towards positive outcomes)
3 months post-treatment
Medical Outcomes Study Short Form 8 Health Survey
Time Frame: Pre- to Post-treatment, average 9 weeks
Mental and physical functioning is assessed by the Medical Outcomes Study Short Form 8 (SF-8) Health Survey. The questions in the SF-8 target eight dimensions of health and are weighted and summed to provide two composite measures, the Physical Composite Scale and Mental Composite Scale (PCS and MCS). The PCS and MCS are scored to range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.
Pre- to Post-treatment, average 9 weeks
Medical Outcomes Study Short Form 8 Health Survey
Time Frame: 3 months post-treatment
Mental and physical functioning is assessed by the Medical Outcomes Study Short Form 8 (SF-8) Health Survey. The questions in the SF-8 target eight dimensions of health and are weighted and summed to provide two composite measures, the Physical Composite Scale and Mental Composite Scale (PCS and MCS). The PCS and MCS are scored to range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.
3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert H Pietrzak, PhD, MPH, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 13-1850
  • U01OH010729 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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