Guided Internet Cognitive Behavior Therapy treatment of Posttraumatic Stress Disorder for Romanian population A study protocol of a randomized controlled trial

This study is a two-armed randomized controlled trial (RCT) with one active treatment condition (TC) and a waiting list control group (WL). The diagnostic interview is conducted before and after the treatment by clinicians blind to the treatment group. The psychologist will be blind according to the score and the evaluations of the participants. Participants will complete the PAXPTSD with guidance from a psychologist. After the evaluation process there is one kickoff meeting discussion of approximately 30 minutes, via Skype, videoconference or telephone to discuss the results of assessments and to discuss the next steps. Participants will receive one module per week. At the end of the program there will be another 30 minutes discussion for debriefing using Skype, videoconference or telephone. The duration and frequency of the intervention will be as follows: one kickoff meeting discussion of approximately 30 minutes; 15 minutes for Q & A for each module; 30 minutes debriefing discussion; the modules will be completed in a maximum of 40 minutes. The first module will explain the symptoms and the rationale for treatment. Modules 2 and 3 will cover relaxation techniques (breathing training and autogenic training). Module 4 will cover the progressive desensitization regarding the traumatic experience. Module 5 will cover the cognitive restructuration techniques. Module 6 will cover the confrontation of traumatic memory using expressive writing. Modules 7 and 8 will target the reduction of avoidance through both interoceptive exposure and exteroceptive exposure respectively. Module 9 will discuss trauma as an opportunity for growth. Module 10 will discuss about the development of positive emotions. Modules 11 will discuss relapse prevention. All participants will complete the standard program for general symptoms of PTSD and it is composed of 11 modules, but the intervention can be personalized according to the comorbidity of participants. We have 5 faculty modules for the comorbidity symptoms. Facultative modules are activated for every participant by his psychologist according to his comorbidities. The facultative modules will cover the reductions of depressive symptoms, shame, anger, and guilt associated with trauma through psychoeducation, cognitive restructuration, and behavioral activation. The total duration of the intervention is 11 weeks. Clinician interviewing and self-report assessments will take place at screening (T0), pre-treatment assessment (T1), post-assessment 11 weeks after randomization (T3), and 3 months follow-up (T4). There will be also weekly mood assessments. All self-report measures are administered through internet and the diagnostic interviews are conducted face to face or via telephone. In case of noncompliance participants will be contacted after 7 days (14, 21) to remind them of assessment completion. After 28 days a short message will be sent via text message. The entire communication between psychologists and participants will be inside the platform. The psychologists from the study will be either licensed psychologists or master students at clinical psychology and psychotherapy. They will support the participants’ adherence by providing reminders using the messaging application available in the platform or via telephone, offering feedback, and monitoring the progress as well as risk for deterioration. Any crisis or any other adverse events are reported to the research team. In cases when participants forget to complete one session, the psychologists will offer reminders and send messages to participants by using platform messages and telephone messages.