Clinical trial NCT03154151: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2017-05-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD symptom change on the PTSD Checklist for DSM-5
timeFrame: Pre- to Post-treatment, average 9 weeks
Secondary outcomes:
measure: Durability of PTSD symptom change on the PCL-5
timeFrame: 3 months post-treatment
measure: Change in PTSD symptom clusters on the PCL-5
timeFrame: Pre- to Post-treatment, average 9 weeks
measure: Durability of change in PTSD symptom clusters on the PCL-5
timeFrame: 3 months post-treatment
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Pre- to Post-treatment, average 9 weeks
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 3 months post-treatment
measure: GAD-7
timeFrame: Pre- to Post-treatment, average 9 weeks
measure: GAD-7
timeFrame: 3 months post-treatment
measure: Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
timeFrame: Pre- to Post-treatment, average 9 weeks
measure: Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
timeFrame: 3 months post-treatment
measure: Medical Outcomes Study Short Form 8 Health Survey
timeFrame: Pre- to Post-treatment, average 9 weeks
measure: Medical Outcomes Study Short Form 8 Health Survey
timeFrame: 3 months post-treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Adriana Feder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Robert H Pietrzak, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: