Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesian PTSD patients: a study protocol for a randomized controlled trial

INTERVENTION: In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre‐intervention (T0) is conducted before he or she are randomised and introduced to the corresponding study arm (study arm 1 and 2). Participants are randomised to one of two groups. This study compares the EMDR condition with an exposure condition, which consists of a similar therapy protocol but excluding the eye movements. The time span between T0 and the first intervention session are kept to about one to two weeks. After four sessions in each condition, stress reactivity is measured again (T1) as well as symptoms of PTSD to monitor potential changes occurring during the process of treatment. Next, post‐intervention assessment are conducted (T2), including stress‐reactivity, brain activity and PTSD symptoms. Finally, at six months (T3) a follow‐up assessment is conducted to be able to evaluate longer‐term effectivity. The follow‐up assessment are performed in two steps. First, participants are contacted personally and motivated to complete the follow‐up instrument. In case participants refuse the telephone interview, they are offered an assessment of the primary outcome only. If participants still refuse, they are asked to provide reasons for their refusal, which is documented. EMDR therapy is given in six sessions, each session lasts 45‐60 minutes. The standard procedure of EMDR are followed: Client history and treatment planning, preparation, assessment, desensitization, installation, body scan, closure, and re‐evaluation. In session 1, all procedures steps are conducted and in the others sessions (session 2 to 7), the therapy can be given from the second stage (preparation) and continued to stage 7 (closure) following reevaluation stage, to see the progress of the individual. In the control group, there is no eye movement during exposure of desensitization and installation phases while all the other c CONDITION: Posttraumatic stress disorder ; Mental and Behavioural Disorders ; Posttraumatic stress disorder PRIMARY OUTCOME: 1. Heart Rate (HR)/Heart Rate Variability (HRV) is measured using the VU AMS device at baseline (T0), during intervention (T1), post‐treatment (T2) and six months follow up (T3); 2. Pre‐ejection period (PEP) is measured using the VU AMS device at baseline (T1), during intervention (T1), post‐treatment (T2) and 6 months follow up (T3) SECONDARY OUTCOME: 1. Cortisol level is measured using salivary samples using The Salimetrics Cortisol Enzyme Immunoassay Kit at baseline (T0), post‐treatment (T2) and six months follow up (T3); 2. PTSD symptom score is measured using CAPS (Clinican Administered PTSD Scale) at baseline (T0), post‐treatment (T2) and 6 months follow up (T3); 3. PTSD symptom score is measured using PTSD Checklist for DSM‐5 at baseline (T0), post‐treatment (T2) and six months follow up (T3) INCLUSION CRITERIA: 1. Individuals who were either diagnosed posttraumatic stress disorder (PTSD) by a professional, i.e., by a clinical psychologist and meet DSM‐V‐TR, the diagnostic rule which requires at least one criteria of A, B, and C and at least two criteria of D and E and with cut off 33 of PCL‐5 score 2. Suffering from posttraumatic stress symptoms on a subclinical level with one symptom in each criterion of PTSD symptoms and with cut off 20 of PCL‐5 score 3. Minimal age of 18 years