McGovern 2011.

Methods	Design: RCT
Participants	Setting: Participants were new admissions to a community addiction treatment program and recruited from 1 of 7 participating community intensive outpatient or methadone maintenance programs. Inclusion criteria: Participants were at least 18 years of age, were actively enrolled in outpatient addiction services, and met criteria for any substance use disorder. Participants were also required to have a diagnosis of PTSD verified by the CAPS with total symptom score equal to or greater than 44. Exclusion criteria: Acute psychotic symptoms (people with a psychotic disorder were eligible if their symptoms were stable and they were receiving appropriate mental health services); psychiatric hospitalisation or suicide attempt in the past month, unless the hospitalisation or attempt was directly related to substance intoxication or detoxification and the person was currently stable; or unstable medical and legal situations such that ability to participate in the full duration of the study seemed unlikely. Sample size: 77 individuals were assessed for eligibility; 53 were randomised, and 36 attended at least 1 treatment session. 53 were included in the analyses. PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS. SUD type and diagnosis: All participants met diagnosis for a substance use disorder. Type of substance use and the number meeting substance dependence were not specified. Mean age: Integrated CBT plus standard care group: 39.09 (SD = 11.32) years; individual addiction counselling plus standard care group: 35.48 (SD = 9.44) years Gender: 23 (43.4%) male; 30 (56.6%) female Ethnicity: 90.6% white; other ethnicities were not described Country: USA
Interventions	Group 1: Integrated cognitive behavioural therapy (ICBT) plus standard care: n = 32. ICBT is a manual‐guided individual‐based therapy focusing on PTSD symptoms and substance use. It was designed for integration into routine community addiction treatment programming. Participants were required to be active in either intensive outpatient or methadone maintenance services. ICBT consisted of 8 modules: introduction to treatment, crisis and relapse prevention planning, breathing retraining, psycho‐education about PTSD primary symptoms, psycho‐education about additional associated symptoms, two cognitive restructuring modules, and generalisation training. ICBT was delivered in an individual format, within a weekly 45‐ to 50‐minute session, over approximately 12 to 14 sessions. A client workbook was to be used in conjunction with the therapist manual with practice handout items for homework in between treatment sessions. Standard care occurred in either methadone maintenance or intensive outpatient clinics. 2 of the 7 recruiting programs were methadone maintenance, and 5 were intensive outpatient programs. Group 2: Individual addiction counselling (IAC) plus standard care: n = 21. IAC is a manual‐guided individual‐based therapy designed to be integrated into an addiction treatment or methadone maintenance program. IAC targeted substance use only and was considered complementary to a typical community addiction treatment program. IAC consisted of 5 modules: treatment initiation, early abstinence, maintaining abstinence, recovery, and termination. IAC was delivered in 10 to 12 weekly sessions. As with ICBT, individual addiction counselling had participant practice handouts for homework in between treatment sessions. Standard care was as described above. Experimental intervention modality: Integrated
Outcomes	PTSD: CAPS SUD: ASI alcohol and drug composites; toxicology: recent alcohol intake and drug metabolites for amphetamine, benzodiazepines, cannabis, cocaine, methamphetamine, and opiates were screened for using urine and breath samples gathered at each assessment period. Treatment acceptability: This was described in terms of initiation (number of participants attending at least 1 treatment session), engagement (number completing at least 2 sessions), and completion (number attending at least 75% of sessions). Other: BDI Follow‐up: 3 and 6 months postbaseline
Notes	It is unclear as to why there is such sizeable difference between the numbers of participants randomised to the 2 conditions
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported. It is reported that research interviewers were blinded to treatment assignment at randomisation, but other information about the randomisation process is not provided
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	High risk	Research interviewers were not blinded to treatment assignment at the follow‐up assessments
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Analysis was undertaken using generalised estimating equations analyses, which allowed analyses without excluding participants based on missing data points or drop‐out. However, the study only achieved a follow‐up rate of 53%, and as the authors acknowledge, this "reduces the power and the ability to detect differences between treatment conditions".
Selective reporting (reporting bias)	Low risk	Primary outcomes are specified in the protocol registered with ClinicalTrials.gov
Other bias	High risk	There were a number of minor differences between the 2 groups at baseline (e.g. PTSD severity). The effects of these differences are unclear. The number of treatment sessions provided to the intervention (12 to 14) was longer than that provided to the control intervention (10 to 12)