Hien 2004.
| Methods | Design: Partial RCT described as a "quasi‐experimental clinical trial" | |
| Participants |
Setting: Participants were recruited through advertisements and referred through substance use treatment programmes. Participants were treated on an outpatient basis. Inclusion criteria: Current or subthreshold PTSD (defined as DSM‐IV criteria A, B, and E and the presence of either C or D) and current DSM‐IV substance dependence; if they reported using substances at least 3 times a week on the Substance Use Inventory; Mini‐Mental State Examination score greater than 21; age 18 to 55 years; female; and English‐speaking. Exclusion criteria: Advanced‐stage medical disease (e.g. AIDS, tuberculosis) as indicated by global physical deterioration and incapacitation, organic mental syndrome (associated with chronic drug abuse), and psychiatric exclusions (current active suicidality; current Axis I diagnoses other than atypical bipolar, depressive, or anxiety disorders; and history of psychosis). Sample size: 207 individuals were assessed for eligibility; 128 met full study eligibility criteria, 115 agreed to participate, and 96 of these were randomised. 32 of the 128 women became a non‐randomised community care comparison group. 75 of the 96 women who were randomised attended at least 1 treatment session and were included in the ITT analyses. PTSD diagnosis: 88% of women met full diagnosis for PTSD as measured by the CAPS. The other 12% met criteria for subthreshold PTSD. SUD type and diagnosis: Women were included on the basis that they met criteria for substance dependence. Women were polydrug users. Mean age: 38.2 (SD = 9.1) for Seeking Safety; 33.8 (SD = 8.3) for relapse prevention. The difference in age was statistically significant. Gender: 128 (100%) female Ethnicity: 42.7% African American; 36% white; 20% Hispanic; 13.3% multiracial; 1.3% other Country: USA |
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| Interventions |
Group 1: Individual‐based Seeking Safety plus standard care: n = 41. The intervention is not fully described but is introduced as a short‐term, manualised cognitive behavioural treatment that simultaneously addresses trauma and substance abuse. Women were offered two 1‐hour treatment sessions weekly over 12 weeks. Group 2: Individual‐based relapse prevention plus standard care: n = 34. The intervention is not fully described but is introduced as an empirically validated cognitive behavioural therapy focusing on the identification of triggers and coping strategies for managing substance cravings and relapse. Group 3: Standard community treatment: n = 32. The intervention is not described. Women in this arm were not randomised. Experimental intervention modality: Integrated |
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| Outcomes |
PTSD: The primary PTSD outcome was a composite score from scores on the CAPS, IES‐R, and CGI Scale. SUD: The primary SUD outcome was a composite score from scores on the Substance Use Inventory and CGI Scale. Treatment acceptability: Data are reported for number of participants attending at least 25% of treatment sessions. Other: Items from CGI Scale were used to assess global severity of psychiatric symptoms; Global Assessment Scale and the HDRS were also used. Follow‐up: 3, 6, and 9 months postbaseline |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to be able to assess |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to be able to assess |
| 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 | Unclear risk | Insufficient information to be able to assess |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Treatment dropouts and withdrawals were clearly reported. An ITT approach was used, using last observation carried forward. However, ITT was based on participants attending at least 1 treatment session. It was unclear if those who were randomised but who did not attend any sessions were aware of their allocation (Fergusson 2002) |
| Selective reporting (reporting bias) | Unclear risk | Composite outcome scores for both PTSD and SUD were used as primary outcomes. The authors state that this was done to reduce the possibility of Type I error. It is unclear how composite scores were generated. Raw scores are reported for PTSD measures but not for SUD measures |
| Other bias | Unclear risk | Insufficient information to be able to assess |