Post-Traumatic Stress DisorderNCT03154151
Online Therapy for Posttraumatic Stress Symptoms in WTC Responders and Survivors
A study testing Online Cognitive-Behavioral Therapy and Online Supportive Therapy in people with Post-Traumatic Stress Disorder, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Online Cognitive-Behavioral Therapy and Online Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Aug 2017to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston University
Boston, Massachusetts, 02215-1703
Yale University
New Haven, Connecticut, 06520-8064
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Online Cognitive-Behavioral Therapy, Online Supportive Therapy
- 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
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive-Behavioral TherapyBehavioural
Also called Online Therapist-assisted Cognitive-Behavioral Therapy, Integrative Testimonial 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.
Online Supportive TherapyBehavioural
Also called Online Therapist-assisted Supportive Therapy, Modified Present-Centered 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.
| Study group | Role | What they receive |
|---|---|---|
| Online Cognitive-Behavioral Therapy | Experimental | 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. Receives: Behavioral: Online Cognitive-Behavioral Therapy |
| Online Supportive Therapy | Active comparator | Through guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing. Receives: Behavioral: Online Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- to Post-treatment, average 9 weeks
Secondary outcomes (11)
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.
Measured: 3 months post-treatment
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).
Measured: Pre- to Post-treatment, average 9 weeks
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).
Measured: 3 months post-treatment
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).
Measured: Pre- to Post-treatment, average 9 weeks
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).
Measured: 3 months post-treatment
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).
Measured: Pre- to Post-treatment, average 9 weeks
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).
Measured: 3 months post-treatment
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)
Measured: Pre- to Post-treatment, average 9 weeks
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)
Measured: 3 months post-treatment
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.
Measured: Pre- to Post-treatment, average 9 weeks
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.
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start21 Aug 2017
- Primary completion20 May 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Adriana Feder, Icahn School of Medicine at Mount Sinai
- Investigators
- Adriana Feder, MD, Principal investigator, Icahn School of Medicine at Mount SinaiRobert H Pietrzak, PhD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154151
- Sponsor's protocol ID
- GCO 13-1850
- Other IDs
- U01OH010729
- Status last verified
- Jan 2022
- First submitted
- 12 May 2017
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Psychotherapies for PTSD Symptoms in World Trade Center (WTC) Responders and Survivors
- ClinicalTrials.gov ID
- NCT03154151
- Acronym / sponsor ID
- GCO 13-1850
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Cognitive-Behavioral Therapy | Experimental | Behavioral: Online Cognitive-Behavioral TherapyThrough 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 comparator | Behavioral: Online Supportive TherapyThrough guided writing, Internet-based supportive therapy aims to help WTC responders and survivors work through any life problems they might currently be experiencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive-Behavioral TherapyAlso: Online Therapist-assisted Cognitive-Behavioral Therapy, Integrative Testimonial TherapyEach 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. | Behavioural | Online Cognitive-Behavioral Therapy |
| Online Supportive TherapyAlso: Online Therapist-assisted Supportive Therapy, Modified Present-Centered TherapyEach 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. | Behavioural | Online Supportive Therapy |
Primary outcome
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.
11 secondary outcomes
Durability of PTSD symptom change on the PCL-5
Time frame: 3 months post-treatment
Change in PTSD symptom clusters on the PCL-5
Time frame: Pre- to Post-treatment, average 9 weeks
Durability of change in PTSD symptom clusters on the PCL-5
Time frame: 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)
Time frame: 3 months post-treatment
GAD-7
Time frame: Pre- to Post-treatment, average 9 weeks
GAD-7
Time frame: 3 months post-treatment
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Time frame: Pre- to Post-treatment, average 9 weeks
Posttraumatic Growth Inventory - 10 Item Short Form (PTGI-SF)
Time frame: 3 months post-treatment
Medical Outcomes Study Short Form 8 Health Survey
Time frame: Pre- to Post-treatment, average 9 weeks
Medical Outcomes Study Short Form 8 Health Survey
Time frame: 3 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Feder, MD principal investigator
Icahn School of Medicine at Mount Sinai
Robert H Pietrzak, PhD, MPH principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive-Behavioral Therapy and Online Supportive Therapy in people with Post-Traumatic Stress Disorder, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom change on the PTSD Checklist for DSM-5 (time frame: Pre- to Post-treatment, average 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.