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Internet-Delivered Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in International Humanitarian Aid Workers: Study Protocol


- candidate number27069
- NTR NumberNTR6525
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-apr-2017
- Secondary IDsNL49966.029.14 METC VUMC
- Public TitleInternet-Delivered Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in International Humanitarian Aid Workers: Study Protocol
- Scientific TitleInternet-Delivered Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in International Humanitarian Aid Workers: Study Protocol
- ACRONYM
- hypothesis1) The intervention (TELLUS) is credible to international humanitarian aid workers, 2) the intervention is significantly reduces symptoms of PTSD from pre- to post-test, and 3) the intervention significantly reduces symptoms of comorbid depression, anxiety, suicidality, and functional disability from pre- to pos-test.
- Healt Condition(s) or Problem(s) studiedCognitive behavior therapy, Post-traumatic stress disorder,
- Inclusion criteria1) currently a staff member of an international humanitarian organization, 2) a full diagnosis of PTSD according to DSM-IV (APA, 1994), or subclinical PTSD with one intrusion, one avoidance and one hyperarousal symptom according to DSM-IV (APA, 1994), as established with the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998), 3) fluency in the English language, 4) access to the Internet and telephone/ Skype, 5) being on a current stable dose of psychiatric medication or medication-free.
- Exclusion criteria1) organic or psychotic disorders, substance dependence or imminent suicide risk as established with the MINI, 2) a diagnosis of PTSD as a result of childhood trauma, 3) receiving psychological treatment at the time of inclusion, 4) being under severe current threat.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate31-dec-2018
- Target number of participants20
- InterventionsTELLUS is an Internet-delivered program based on trauma-focused CBT components for PTSD (Ivarsson et al., 2014). The treatment program contains eight text-based modules, where each module is expected to be completed within one week. The modules have homework assignments related to their content, which are communicated online with a supervised psychologist on a weekly basis.
- Primary outcome1) Credibility/ expectancy, 2) Significant reductions in symptoms of PTSD from pre- to post-test.
- Secondary outcome1) Significant reductions in symptoms of comorbid depression, anxiety, suicidality, and functional disability from pre- to pos-test, 2) Treatment completion rates.
- TimepointsThe treatment is expected to last eight weeks and assessments are done: 1) before beginning of treatment (pre-treatment), 2) after four modules of the treatment (mid-treatment), 3) after completion of all eight modules of the treatment (post-treatment).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Marit Sijbrandij
- CONTACT for SCIENTIFIC QUERIESDr. Marit Sijbrandij
- Sponsor/Initiator VU University Medical Center, Department of Clinical Psychology
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIntroduction: Humanitarian aid workers are likely to be exposed or witness complex emergencies. Posttraumatic stress disorder (PTSD) is one of the most widespread and most commonly studied mental health problems after exposure to adversities and trauma. However, face-to-face treatment has limited utilization in the resource-constrained settings where humanitarian aid workers often operate. Internet-delivered cognitive behavioral therapy (iCBT) is a treatment option with the potential to improve the access to evidence-based care for humanitarian aid workers. Until now, only a few studies have evaluated iCBT in the treatment of PTSD. No studies have yet explored the feasibility of iCBT for humanitarian aid workers with PTSD. The aim of this study is to determine completion rates, self-reported treatment credibility/expectancy, and decrease in symptoms (PTSD, anxiety, depression, and functional disability) of the TELLUS program in humanitarian aid workers with PTSD. Methods: A pilot feasibility study will be conducted with 20 humanitarian aid workers with a full or subclinical PTSD diagnosis according to DSM-IV criteria. The intervention used is TELLUS, which is a therapist-assisted Internet-delivered treatment program based on trauma-focused CBT components for individuals with PTSD. It contains eight text-based modules, where each module is expected to be completed within one week.
Discussion: This study may set the ground for a large-scale randomized control trial that would test the effectiveness and cost-effectiveness of the program. The study may contribute to the better understanding of PTSD treatment and increase the availability of evidence-based treatments in resource-constrained settings.
- Main changes (audit trail)
- RECORD10-apr-2017 - 14-jul-2017


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