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Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Cognitive-Behavioral Therapy
Online Supportive Therapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Post-Traumatic Stress Disorder, Post-Traumatic Stress Disorder symptoms, World Trade Center, 9/11, first responder, rescue/recovery/clean-up worker, trauma, 9/11 survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University
  • Boston University
  • James J. Peters VA Medical Center
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online Cognitive-Behavioral Therapy

Online Supportive Therapy

Arm Description

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.

Through guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Durability of PTSD symptom change on the PCL-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.
Change in PTSD symptom clusters on the PCL-5
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).
Durability of change in PTSD symptom clusters on the PCL-5
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).
Beck Depression Inventory II (BDI-II)
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).
Beck Depression Inventory II (BDI-II)
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).
GAD-7
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).
GAD-7
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).
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
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)
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
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)
Medical Outcomes Study Short Form 8 Health Survey
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.
Medical Outcomes Study Short Form 8 Health Survey
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.

Full Information

First Posted
May 12, 2017
Last Updated
January 8, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
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1. Study Identification

Unique Protocol Identification Number
NCT03154151
Brief Title
Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors
Official Title
Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Post-Traumatic Stress Disorder, Post-Traumatic Stress Disorder symptoms, World Trade Center, 9/11, first responder, rescue/recovery/clean-up worker, trauma, 9/11 survivor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Supportive Therapy
Arm Type
Active Comparator
Arm Description
Through guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing.
Intervention Type
Behavioral
Intervention Name(s)
Online Cognitive-Behavioral Therapy
Other Intervention Name(s)
Online Therapist-assisted Cognitive-Behavioral Therapy, Integrative Testimonial Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Supportive Therapy
Other Intervention Name(s)
Online Therapist-assisted Supportive Therapy, Modified Present-Centered Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptom change on the PTSD Checklist for DSM-5
Description
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.
Time Frame
Pre- to Post-treatment, average 9 weeks
Secondary Outcome Measure Information:
Title
Durability of PTSD symptom change on the PCL-5
Description
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.
Time Frame
3 months post-treatment
Title
Change in PTSD symptom clusters on the PCL-5
Description
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).
Time Frame
Pre- to Post-treatment, average 9 weeks
Title
Durability of change in PTSD symptom clusters on the PCL-5
Description
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).
Time Frame
3 months post-treatment
Title
Beck Depression Inventory II (BDI-II)
Description
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).
Time Frame
Pre- to Post-treatment, average 9 weeks
Title
Beck Depression Inventory II (BDI-II)
Description
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).
Time Frame
3 months post-treatment
Title
GAD-7
Description
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).
Time Frame
Pre- to Post-treatment, average 9 weeks
Title
GAD-7
Description
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).
Time Frame
3 months post-treatment
Title
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Description
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)
Time Frame
Pre- to Post-treatment, average 9 weeks
Title
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Description
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)
Time Frame
3 months post-treatment
Title
Medical Outcomes Study Short Form 8 Health Survey
Description
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.
Time Frame
Pre- to Post-treatment, average 9 weeks
Title
Medical Outcomes Study Short Form 8 Health Survey
Description
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.
Time Frame
3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Feder, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert H Pietrzak, PhD, MPH
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8064
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-1703
Country
United States
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors

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