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Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors

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ClinicalTrials.gov Identifier: NCT03154151
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
Adriana Feder, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Online Cognitive-Behavioral Therapy Behavioral: Online Supportive Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online Cognitive-Behavioral Therapy
Through guided writing, Internet-based cognitive therapy aims to help WTC responders process any traumatic experiences they lived through during their WTC recovery work.
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 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
  • Supportive Psychotherapy




Primary Outcome Measures :
  1. PTSD symptom improvement on the PTSD Checklist for DSM-5 [ Time Frame: up to 3 months ]
    WTC-related PTSD symptoms, assessed using total PTSD Checklist-5 (PCL-5) and subscale scores.


Secondary Outcome Measures :
  1. Treatment response [ Time Frame: up to 3 months ]
    Treatment response assessed using a categorical response variable indicating clinically significant PTSD caseness (i.e., meet vs. do not meet criteria for full or partial WTC-related PTSD).

  2. PHQ-9 [ Time Frame: up to 3 months ]
    Patient Health Questionnaire (PHQ-9) is a 9-item scale for measuring the severity of depression, each item scored 0 (not at all) to 3 (nearly every day) with total from 0 (minimal depression) to 27 (severe depression).

  3. GAD-7 [ Time Frame: up to 3 months ]
    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).

  4. Posttraumatic Growth Inventory (PTGI) [ Time Frame: up to 3 months ]
    Psychological growth following a traumatic experience is assessed with the PTGI. PTGI is a 21-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 105 (much change towards positive outcomes)

  5. Medical Outcomes Study Short Form 12 Health Survey [ Time Frame: up to 3 months ]
    Mental and physical functioning is assessed by the Medical Outcomes Study Short Form 12 (SF-12) Health Survey. The questions in the SF-12 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154151


Contacts
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Contact: Hannah Brinkman, BA 212-241-6163 hannah.brinkman@mssm.edu
Contact: Olivia Diab, BA 212-659-9279 olivia.diab@mssm.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8064
Contact: Robert H Pietrzak, PhD    203-785-2117    robert.pietrzak@yale.edu   
Principal Investigator: Robert H Pietrzak, Phd         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215-1703
Contact: Charla Rhodes       Charla.Rhodes@va.gov   
Principal Investigator: Brett Litz, PhD         
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Heaher Bader    718-741-4000 ext 5209    heather.bader@va.gov   
Principal Investigator: Rachel Yehuda, PhD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Hannah Brinkman, BA    212-241-6163    hannah.brinkman@mssm.edu   
Contact: Olivia Diab, BA    212-659-9279    olivia.diab@mssm.edu   
Principal Investigator: Adriana Feder, MD         
Principal Investigator: Robert H. Pietrzak, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
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Principal Investigator: Adriana Feder, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Robert H Pietrzak, PhD, MPH Yale School of Medicine

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Responsible Party: Adriana Feder, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03154151     History of Changes
Other Study ID Numbers: GCO 13-1850
U01OH010729 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adriana Feder, Icahn School of Medicine at Mount Sinai:
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

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders