Mueser 2008.
| Methods | Design: RCT | |
| Participants |
Setting: Individuals with severe mental illness were recruited from community mental health centres. Inclusion criteria: Minimum age 18 years; designation by the states of New Hampshire or Vermont as having a severe mental illness, defined as a DSM–IV Axis I disorder and persistent impairment in the areas of work, school, or ability to care for oneself; DSM–IV diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia; current DSM–IV diagnosis of PTSD; and legal ability and willingness to provide informed consent to participate in the study. Exclusion criteria: Psychiatric hospitalisation or suicide attempt within the past 3 months; current DSM–IV substance dependence. Sample size: 270 individuals were assessed for eligibility; 108 were randomised, and all were included in the analyses. PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS. SUD type and diagnosis: Nature of substance abuse was not specified. 44 (40.7%) of participants met diagnosis for substance use disorder. Outcome data are available for this subgroup. Mean age: 44.21 (SD = 10.64) years Gender: 35/44 (79.5%) female Ethnicity: 38 (86.4%) white; (4.5%) African American; (4.5%) American Indian/Alaska Native; (2.3%) Hispanic; (2.3%) Asian‐Pacific Islander Country: USA |
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| Interventions |
Group 1: Individual CBT for PTSD: n = 17. Sessions included an introduction to the programme; crisis plan review; psycho‐education on core and associated symptoms of PTSD; cognitive restructuring; generalisation training; and termination. Participants were offered 12 to 16 sessions over 4 to 6 months. Group 2: Treatment as usual: n = 27. Participants assigned to TAU continued to receive the usual services they had been receiving before enrolment in the program. None of the mental health centres offered either cognitive restructuring or exposure therapy treatments for PTSD, although supportive counselling for trauma‐related problems was available. Experimental intervention modality: Treatment of PTSD only |
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| Outcomes |
PTSD: CAPS SUD: ‐ Treatment acceptability: Data are reported for number of participants in the experimental condition attending at least 6 treatment sessions. Other: PTCI; PTSD Knowledge Test; Brief Psychiatric Rating Scale; BDI‐II; BAI; 12‐Item Short Form Health Survey; client version of the Working Alliance Inventory Follow‐up: End of treatment and at 3 and 6 months' post‐treatment |
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| Notes | This study did not specifically aim to treat individuals meeting diagnosis for SUD. A subset of participants met SUD diagnosis, and study authors provided data for these individuals. These participants only met criteria for substance abuse; individuals meeting diagnosis for substance dependence were excluded | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was conducted by a computer‐based randomisation program |
| Allocation concealment (selection bias) | Low risk | Randomisation was conducted at a central location in a research centre. Assignments were not known in advance by either clinical or research staff |
| 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 | Assessments were conducted by blinded interviewers at all assessment points. Participants were instructed at the beginning of interviews not to talk about any treatments for trauma‐related problems they may have received. Interviewers were requested to inform the project co‐ordinator if the client broke the blind during an interview. Interviewers were not asked to guess clients’ treatment assignments, to avoid directly encouraging them to formulate hypotheses about how treatment may have affected clients’ symptoms, which could have influenced subsequent ratings. No specific instances of blind breaking were noted in the study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals are thoroughly described. ITT analysis was conducted to determine the effects of primary outcomes |
| Selective reporting (reporting bias) | Unclear risk | Outcomes were reported as specified in the methodology section, but we were not able to identify a previously published protocol |
| 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 |