Meffert 2014.
Methods | Pilot RCT | |
Participants | Sudanese refugees living in Cairo, Egypt. Darfurians have been attacked by government‐backed militias and have fled to Egypt. They have undergone intense traumatic exposure, including rape, murder of family members, and narrow escape from death. The trial was conducted from April to August 2008 Patients were screened according to the following selection criteria: absence of cognitive dysfunction that required a higher level of care or interfered with the ability to participate in IPT, absence of severe thought or mood disorder symptoms that required a higher level of care or interfered with the ability to participate in IPT, absence of drug and alcohol dependence, HTQ score of 2.3 or greater, ability to attend twice‐weekly therapy sessions for 3 weeks and return for regular screening, and ability to give verbal informed consent Age: 21‐42 years |
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Interventions | Interpersonal psychotherapy (IPT): 13 participants Wait list control: 9 participants |
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Outcomes | PTSD (Harvard Trauma Questionnaire ‐ HTQ); depression (Beck Depression Inventory‐II ‐ BDI–II); family violence (Conflict Tactics Scale ‐ CTS); anger expression (State‐Trait Anger Expression Inventory ‐ STAXI) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Eligible participants were randomly assigned using a computer‐generated random allocation sequence" |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants were not blinded to group status" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Therapists were not blind to group status" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% of participants abandoned the study prematurely Study endpoint: 2/13 missing from IPT group; 1/9 missing from WL group |
Selective reporting (reporting bias) | Low risk | The study protocol is not available, but it is clear that published reports include all expected outcomes |
Therapist qualification | Unclear risk | Quote: "Sudanese mental health professionals were not available in Cairo, so community members without previous mental health education were trained to deliver the care" |
Treatment fidelity | Unclear risk | No information provided |
Therapist/investigator allegiance | Unclear risk | No information provided |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out |