Sannibale 2013.
| Methods | Design: RCT | |
| Participants |
Setting: Participants were recruited from a range of services in metropolitan Sydney, Australia and seen on an outpatient basis. Inclusion criteria: Individuals were eligible if they were 18 years of age or older, consumed alcohol at hazardous levels (men 29 or more and women 15 or more 10 g ethanol drinks per week) and met DSM‐IV diagnostic criteria for PTSD, determined by the CAPS. AUD diagnosis was determined by the Structured Clinical Interview for DSM‐IV. Individuals on stable doses (for 2 months or longer) of pharmacotherapy for depression or alcohol dependence were eligible, as were individuals who needed and completed alcohol withdrawal. Exclusion criteria: People were excluded if they were 17 years or younger, had current psychosis, severe suicide risk, significant cognitive impairment, limited English comprehension, or severe substance dependence. Sample size: 154 individuals were screened and 90 assessed for eligibility; 62 were randomised, and all were included in the analyses. PTSD diagnosis: 58 (94%) of participants met full diagnosis for PTSD as measured by the CAPS. SUD type and diagnosis: All participants met criteria for AUD. Mean age: 41.18 (SD = 11.91) years Gender: 33 (53%) female Ethnicity: Not reported Country: Australia |
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| Interventions |
Group 1: Integrated CBT for PTSD and AUD: n = 33. Participants in both conditions received the same treatment targeting AUD. This consisted of motivational interviewing, intervention focused on coping with cravings, cognitive intervention related to drinking and management of negative moods. Participants in this arm also received cognitive behavioural intervention for PTSD, based on a prolonged exposure model with cognitive restructuring. Treatment in both the experimental and control condition was manualised, and consisted of 12, once‐weekly 90‐minute individual sessions with structured daily homework tasks. Group 2: CBT for AUD and supportive counselling: n = 29. In addition to the shared components described above, this group also received supportive counselling. Treatment in this arm targeted AUD symptoms only, not PTSD symptoms. Experimental intervention modality: Combined |
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| Outcomes |
PTSD: CAPS, PDS SUD: TLFB, SADQ Treatment acceptability: Median sessions attended, number attending 1 or more sessions, 6 or more sessions, 9 or more sessions. Other: Short Inventory of Problems, BDI, STAI Follow‐up: Post‐treatment and 5 and 9 months' post‐treatment |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was conducted according to a random number system by a person independent of the study ... " |
| Allocation concealment (selection bias) | Low risk | " ... and treatment was concealed." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Follow‐up assessments were conducted by independent clinicians who were unaware of the participants’ treatment condition and did not have access to participant clinical or supervision notes or treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All analyses were based on intent‐to‐treat, including all participants who entered the trial |
| Selective reporting (reporting bias) | Low risk | Outcomes were reported as specified in the methodology section |
| Other bias | Low risk | There were no differences between the groups on any demographic, diagnostic, or baseline measures or in the rates of follow‐up assessments |