Foa 2005.
Methods | Randomised controlled trial | |
Participants | 171 female sexual assault survivors in the USA | |
Interventions | 9 ‐ 12 weekly 90‐ to 120‐minute sessions of prolonged exposure (n = 79) vs 9 ‐ 12 weekly 90‐ to 120‐minute sessions of prolonged exposure and cognitive restructuring (n = 74) vs waiting list (n = 26) (all interventions included in meta‐analyses). | |
Outcomes | PSS‐I, BDI, SAS | |
Notes | Experienced therapists delivered therapy and treatment adherence was assessed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The study statistician assigned participants who provided informed consent to one of the three conditions using a weighted randomizations procedure such that participants were assigned to one of the active treatment conditions at a greater rate than to WL." Comment: Although reported to be carried out by a statistician, the method of sequence generation is unclear. |
Allocation concealment (selection bias) | Low risk | Quote: "The study statistician assigned participants who provided informed consent to one of the three conditions using a weighted randomizations procedure such that participants were assigned to one of the active treatment conditions at a greater rate than to WL." Comment: Participants were assigned to a group by an external person. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: ITT analyses were performed. Reasons for drop‐out were not fully reported. There were many drop‐outs (1 from waiting list, 30 from PE/CR and 27 from PE). |
Selective reporting (reporting bias) | Low risk | Comment: All specified outcomes were 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: "All evaluations were conducted by trained doctoral or master’s level CTSA clinicians who were blind to study condition." "Participants were instructed by their therapists and the evaluators to not reveal any information that might unblind the evaluator to treatment condition." |