Asukai 2010.
Methods | Randomised controlled trial | |
Participants | 24 individuals (Japanese) with DSM‐IV PTSD after various traumas (21 women, 3 men) | |
Interventions | 8 ‐ 15 90‐minute sessions of Prolonged Exposre (TFCBT) (n = 12) sessions vs treatment as usual (TAU) (n = 12) | |
Outcomes | CAPS, IES‐R, CES‐D, GHQ‐28 | |
Notes | Therapists were masters level psychologists. TAU included pharmacotherapy. Baseline demographics were similar within both groups. The difference in scores between both groups was nonsignificant at baseline on any of the assessment scales. Treatment adherence was measured. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomized by the study site based on computer‐generated random digit numbers by permuted blocks between 4 and 8." |
Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment was not reported. Participants were randomised at the study site. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "intention‐to‐treat analysis was performed to determine the relative effect between the two treatment groups for each periodic posttreatment assessment, and those between pre‐PE (after the waiting period) and post‐PE treatment in the control group (CAPS total score, IES‐R, CES‐D, and GHQ‐28)." Comment: 3 dropped out from TFCBT, and one from TAU. A reason was only reported for one of these drop‐outs. |
Selective reporting (reporting bias) | Low risk | Comment: All specified and expected outcomes appear to have been reported. |
Other bias | Low risk | Comment: There were no other obvious sources of bias. |
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." |