Acaturk 2016.
Methods | Single‐blind, parallel‐group, open‐label RCT | |
Participants | Refugees with PTSD symptoms forced to leave Syria owing to the war that started in 2011; living in Kilis Refugee Camp. The camp is located at the border between Turkey and Syria. Refugees, in addition to displacement and lack of shelter, have been exposed to traumatic events such as torture, serious injury to self or loved ones, death of family members, husband at war, and arrested family members The study was conducted between September 2013 and June 2014 Age range: 19‐63 years Inclusion criteria: diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM‐IV); 18 years of age and older Exclusion criteria: diagnosis of psychotic disorder or substance abuse according to DSM‐IV; pregnant; any psychotherapy during the trial; concurrent use of any psychotropic medication during the trial |
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Interventions | Eye movement desensitisation and reprocessing (EMDR) intervention: 49 participants EMDR given in different phases, including history taking, case formulation, and treatment planning; EMDR explanation; trauma memory selection; desensitisation; reporting of current emotions, sensations, and cognitions; and instillation of positive cognition. The closure phase is focused on relaxation Wait list control group: 49 participants Wait list participants did not receive any psychological or pharmacological treatment. They were informed that at the end of the study, they could receive psychological help from the research team |
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Outcomes | Exposure to traumatic events and PTSD symptoms measured with the Harvard Trauma Questionnaire (HTQ) and the Impact of Event Scale ‐ Revised (IES‐R); symptoms of depression were measured with the Beck Depression Inventory (BDI‐II) and the Hopkins Symptoms Checklist (HSCL‐25) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "After including the participants, another researcher, not involved in the current study, used a computer generated random‐number list for the allocation of participants to different treatment groups" |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The participants and the therapists were necessarily aware of the allocated arm" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The outcome assessors were kept blind to the allocation" |
Incomplete outcome data (attrition bias) All outcomes | High risk | The dropout rate was higher than 20%. Dropouts in intervention group: 12/49; in control group: 16/49 |
Selective reporting (reporting bias) | Low risk | All outcomes are reported |
Therapist qualification | Low risk | Trained psychologists |
Treatment fidelity | Low risk | Quote: "The supervisor checked whether the therapists were complying with the protocol during at least one live session of each therapist and conducted one‐to‐one and group supervision sessions" |
Therapist/investigator allegiance | High risk | Psychologists were trained in EMDR (level II) and R‐TEP (Recent Traumatic Episode Protocol) by the second trial author, who is an EMDR Institute‐accredited trainer. No further information provided |
Other bias | Low risk | The study appears to be free from other sources of bias |