None listed
Conditions
Brief summary
Background: Soldiers of the German Armed Forces are regularly confronted with intense physical and mental demands. Up to three percent develop PTSD but a significant proportion of soldiers with PTSD does not make use of conventional mental health services. Reasons include limited treatment capacities, concerns and barriers on the soldiers’ side and illness-related impairments. Internet-based interventions are less affected by these barriers and well established as an effective treatment approach for PTSD. This study seeks to investigate the acceptance, efficacy and the mechanisms of change of an online PTSD-intervention for military personnel. Intervention: The treatment protocol is a modified version of “Interapy” originally developed by Lange and colleagues. It is based upon the well-established cognitive behavioural intervention approaches of exposure and cognitive restructuring. Within this therapist-guided online writing therapy the patient receives structured writing tasks and individual feedback by a personal therapist. The first 3 sessions consist of written biographical reconstruction. The next 4 writing assignments contain trauma exposure. The last 3 tasks aim at cognitive reappraisal of trauma-related dysfunctional beliefs. Method: Both treatment groups (intervention group and wait list/intervention group) are compared with regard to the primary and secondary outcomes (e.g. symptoms of PTSD, life satisfaction), predictors of treatment-success (e.g. social support, therapy expectations and therapeutic relationship) and indicators of mechanisms of change (e.g. hormone levels, attention bias, biomarkers and heart rate during exposure). The healthy control group acts as baseline comparison group and neither receives treatment nor follow-up assessments. Questions of research Quantitative: (1) Efficacy of the intervention (quantitative outcome measures) (2) Change of diagnosis (categorical outcome) (3) Changes in psychophysiological markers and biomarkers over the course of treatment Qualitative: (1) Potential side effects of the intervention
Interventions
Type of intervention: Therapist-guided internet-based intervention. The intervention is delivered via an online platform. Duration and general information: Intervention and treatment procedure: The internet-based intervention lasts 5 weeks and includes 10 structured writing assignments. Patients complete two assignments per week. Each assignment requires approximately 45 minutes of writing time. Communication between patient and therapist takes place within a secure messaging system that is part of the online intervention platform. Participants receive standardized instructions for each of the writing tasks and written feedback after one working day from a trained psychotherapist (personally assigned) after eight of the ten writing tasks. Participants do not receive feedback after session 2 (biographical reconstruction) and after session 5 (moderate exposure). The feedback consists of generic parts that are complemented by individual feedback tailored to the participants’ specific needs (e.g. recognition for disclosing experiences, encouragement for exposure to traumatic event, reinforcement and motivation). Additionally, participants are able to contact the intervention team if technical support is required. For questions related to the treatment, patients can contact their personal therapist via e-mail (additional contact on demand). Requests will be answered within one working day. Adherence: Login of participants is monitored and participants are asked to determine a specific date at which they plan to work through the next assignment. If participants miss an intended date, the therapist receives an automatic notification and contacts the client via e-mail. Assessment and evaluation: Before and after the treatment, patients are invited for 3 (treatment group, n=50) or 4 (wait list control group, n=50) face-to-face diagnostic and assessment sessions at the German Army Hospital in Berlin. Trained research staff conducts structured clinical interviews (CAPS, M.I.N.I. and Mini-ICF-APP) with all patients before onset of the treatment. Furthermore, the diagnostic assessments include self-report questionnaires (e.g. PCL-5), psychophysiological measures (e.g. eye-tracking, heart rate) and an assessment of biomarkers (e.g. HPA-axis markers, cytokines and oxytocin). In addition, patients are asked to collect saliva samples for two consecutive weekdays after each assessment session. Saliva samples for cortisol analysis as well as heart rate measurements are also included in two of four exposure sessions (see below) and are guided by instructions via the online-platform. Training of research staff and psychotherapists: The research staff consists of four psychologists that receive practical training for conducting clinical interviews and all assessment procedures prior to the study onset. Specifically, training takes 3 days (8 hours each) and includes performance of clinical interviews (M.I.N.I., CAPS) and concrete instructions on how to apply assessments (heart rate, sleep EEG, eyetracking assessment). Two experienced psychotherapists receive a 2-day-training (8 hours each) on how to use the online intervention platform and on how to implement the intervention protocol and to interact with participants. The study team is accompanied by a military study physician who provides additional training for critical situations and population specific demands. Supervision is scheduled weekly. Contents, aims and methods of the intervention in detail: Biographical reconstruction (Session 1-3) Topic: Essays on three life phases: 1) from birth to age of 10, 2) age of 11 to 18, 3) age of 18 until occurrence of the traumatic event(s) Aim: Narrative reconstruction of own biography; identification of resources Method: Written biographical reconstruction Moderate Exposure (Session 4-7) Topic: Repeated detailed description of the traumatic event(s) Aim: Alteration of trauma memory Method: Written trauma exposure Cognitive Reappraisal (Session 8-10) Topic: Supportive letter to younger self, coping with events in the future Aim: Integration of traumatic event in biography, to gain a new perspective on the event (e.g., challenging dysfunctional automatic thinking, correction of unrealistic assumptions) Method: Written cognitive restructuring
Sponsors
Study design
Eligibility
Inclusion criteria
Treatment group/Waitlist control group: German-speaking soldiers (active and out of duty) of the German Armed Forces suffering from Posttraumatic Stress Disorder (PTSD). Participants need to have access to the internet. Healthy control group: German-speaking soldiers of the German Armed Forces who have experienced a potentially traumatic event or who have never experienced a potentially traumatic event.
Exclusion criteria
Treatment group/Waitlist control group: Patients with schizophrenia, schizotypal and delusional disorders (ICD-10: F20-F29) Suicidal patients Patients with acute manic episode Patients with acute substance abuse or dependence Patients in concurrent psychotherapeutic treatment Healthy controls group: Subjects fulfill criteria of PTSD or any other mental disorder