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
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: Online Cognitive-Behavioral Therapy Behavioral: Online Supportive Therapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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).
- 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).
- 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).
- 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)
- 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.
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
|Contact: Hannah Brinkman, BAfirstname.lastname@example.org|
|Contact: Olivia Diab, BAemail@example.com|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520-8064|
|Contact: Robert H Pietrzak, PhD 203-785-2117 firstname.lastname@example.org|
|Principal Investigator: Robert H Pietrzak, Phd|
|United States, Massachusetts|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Olivia Diab, BA 212-659-9279 email@example.com|
|Principal Investigator: Adriana Feder, MD|
|Principal Investigator: Robert H. Pietrzak, PhD|
|Principal Investigator:||Adriana Feder, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Robert H Pietrzak, PhD, MPH||Yale School of Medicine|