| Methods |
Randomised controlled trial |
| Participants |
34 refugees (in Germany) with a history of violence and persecution, suffering PTSD (15 women, 19 men) |
| Interventions |
12 sessions of Narrative Exposure Therapy (NET) (n = 16) vs waitlist control (n = 18) in parallel |
| Outcomes |
CAPS, HDRS, ssVEF |
| Notes |
Experienced therapists delivered therapy. Treatment adherence was not assessed, but monitored in supervision sessions. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Participants that fulfilled the inclusion criteria were randomized into the two groups using a computer‐generated list of random numbers". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: Allocation concealment was not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: " As this study focuses on brain changes through psychotherapy rather than examining the clinical efficacy of the treatment, we restricted all analyses to the sample of study completers". Drop‐out rates were one participant from treatment and two from waitlist, all due to deportation. Data for a further 4 participants were excluded from the treatment group, and another 8 from waitlist, due to no/poor‐quality MEG data. |
| Selective reporting (reporting bias) |
High risk |
www.clinicaltrials.gov‐/ct2/show/NCT00563888 specified the CAPS as primary outcome and ssVEFs as secondary. The paper is written in terms of ssVEF as primary outcome. The paper trials register also specifies a 4‐ and 9‐month follow‐up. |
| Other bias |
High risk |
There was a mean difference of 16 points in pretreatment CAPS scores between the two groups (NET being greater). |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: Participants were aware of their allocation. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Two independent female masters‐level psychologists, who were unaware of the patients’ treatment group, performed all assessments at pretreatment, posttreatment, and 3‐ and 6‐month follow‐up. The 12‐month follow‐up assessment was conducted via mail. Blindness was maintained by ensuring that the assessors had no access to group allocation and never talked with patients about which group they were in." |
