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. 2016 Apr 4;2016(4):CD010204. doi: 10.1002/14651858.CD010204.pub2

Coffey submitted.

Methods Design: RCT
Participants Setting: Participants were recruited from an unlocked residential SUD treatment facility.
Inclusion criteria: DSM‐IV diagnosis of both PTSD related to a non‐combat trauma and alcohol dependence; 1 heavy drinking day in the past 60 days, as defined by consumption of 4 standard drinks for women and 5 standard drinks for men; and age between 18 and 60.
Exclusion criteria: The presence of an acute psychotic disorder, bipolar disorder with an active manic episode (but not the presence of bipolar disorder, per se), imminent risk for suicide, prescription of craving‐reducing medications (e.g. naltrexone) or medications to reduce alcohol use (e.g. disulphiram), self reported use, or urine drug screen indicating use, of a benzodiazapine, judged to have a medical condition that might limit co‐operation or compromise the integrity of the data (e.g. organic brain syndrome, dementia, head injury, neuropathy, etc.), illiteracy in English, and being in an ongoing abusive relationship that resulted in a PTSD Criterion A event (but not a history of intimate partner violence, per se).
Sample size: 222 individuals were assessed for eligibility; 148 were randomised, but 28 were subsequently excluded. Reasons for exclusion included cognitive impairment, psychosis, medical issues, drug screening, moved away, refusal to participate, and in one case for unknown reasons. The remaining 120 participants attended at least 1 treatment session and were included in analyses.
PTSD diagnosis: All participants met full diagnosis for PTSD as measured by the CAPS.
SUD type and diagnosis: All participants met diagnosis for alcohol dependence and 98.3% met criteria for other drug dependence, as measured by the CDIS‐IV.
Mean age: 33.72 (SD = 10.25) years
Gender: 64 (53.3%) male; 56 (46.7%) female
Ethnicity: 18.3% African American; 80.0% white; 0.8% other
Country: USA
Interventions Group 1: Trauma‐focused exposure therapy (EXP) + TAU: n = 82. EXP is a well‐described cognitive behavioural therapy that utilises imaginal and in vivo exposure techniques, either singly or in combination, to reduce the symptoms of PTSD resulting from a range of traumas. In addition to imaginal and in vivo exposure techniques, in the current study participants were provided psycho‐education about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. The imaginal exposures were audiotaped, and participants were instructed to listen to the tapes daily. 9 sessions of exposure were offered initially; if PTSD symptom severity did not decrease by at least 70%, an additional 3 sessions of EXP were offered. A number of adaptations were made to conventional exposure. Traditionally, exposure sessions are 90 minutes. The current study utilised 60‐min EXP sessions. Additionally, protocol contained added psycho‐education about the relationship between trauma and SUD symptoms and weekly check‐ins about SUD treatment progress. Finally, the protocol provides integration of care at the team level, rather than the individual provider level. All participants received standard TAU for substance abuse. TAU consisted of daily group therapy for approximately 3 hours each day, daily recreation therapy, AA and NA meetings, individual drug counselling sessions, and completion of drug counselling homework. The 6‐week TAU was provided by drug and alcohol counsellors unaffiliated with the current study.
Group 2: Healthy Lifestyles Sessions (HLS) + TAU: n = 38. HLS is a structured 9‐ to 12‐session intervention that provides education about a variety of health‐related topics. HLS was designed to involve a similar amount of therapist contact and between‐session homework as exposure. Topics covered included an introduction to treatment; sleep hygiene; progressive muscle relaxation; starting/maintaining an exercise programme; personal role identification; healthy eating and nutrition (2 sessions); diabetes (prevention or diabetes treatment adherence, depending on diabetes status); monitoring goals and values; cancer (a focus on breast cancer for women and colon cancer for men); HIV (reducing HIV risk or adhering to HIV treatment, depending on HIV status); and a final review session. Sessions included the provision of information, discussing participants’ understanding of information, and answering questions about the information provided.
Experimental intervention modality: Combined
Outcomes PTSD: CAPS; IES‐R
SUD: TLFB, the primary outcome was per cent days abstinent; ACQ‐Now
Treatment acceptability: Number completing at least 8 treatment sessions
Other: BDI; BAI
Follow‐up: End of treatment; 3 and 6 months post‐treatment
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence generation was undertaken by urn randomisation
Allocation concealment (selection bias) Unclear risk Not reported
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 Assessors were blind to treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Treatment dropouts and withdrawals were clearly reported. An ITT approach was used to analyse data based on participants who attended at least 1 treatment session. A number of other participants were also excluded from the study postrandomisation, and it was unclear if some of these exclusions might have been due to intervention‐related factors
Selective reporting (reporting bias) Unclear risk All outcomes that were described were reported, but we were not able to identify a previously published protocol
Other bias Unclear risk 28 individuals who were randomised were removed from the study. It is unclear whether this may have caused additional bias. Approximately half of the participants receiving the experimental intervention were also provided a session of motivational enhancement therapy for PTSD prior to beginning intervention. The other half of the experimental group and all of the HLS participants were provided a 60‐minute relaxation session prior to the first scheduled treatment session. No significant differences were found between the 2 experimental groups, and they were therefore collapsed into a single experimental condition