Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders.

Abstract

We compared the effectiveness of Seeking Safety (SS), an integrated cognitive behavioral treatment for substance use disorder (SUD) and post-traumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within NIDA's Clinical Trials Network. We randomized 353 women to receive 12 sessions of SS (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment at post-treatment and 3-, 6-, and 12-months post-treatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS) and PTSD Symptom Scale-Self Report (PSS-SR), and substance use (self-reported abstinence in the prior 7 days and days per week of any substance use). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively), but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline, when 46% of participants were abstinent. Study results do not favor SS over WHE as an adjunct to SUD treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript in community based drug treatment, revealing a significant need for therapeutic approaches that can address adverse psychiatric consequences (e.g., Shore, Vollmer, & Tatum, 1989;Breslau, Davis, Andreski, & Peterson, 1991;Resnick, Kilpatrick, Dansky, Saunders, & Best, 1993). Yet, treatment research in this area remains limited.Quasi-experimental and small controlled studies (i.e., Finkelstein et al., 2004) suggest that a services model integrating cognitive behavioral treatment for trauma with substance abuse services can result in modest improvements in outcome (e.g., Amaro et al., 2007;Morrissey et al., 2005). For PTSD without co-occurring substance abuse, cognitive behavioral approaches have shown evidence of efficacy (e.g., Cloitre, Koenen, Cohen, & Han, 2002;Foa, Rothbaum, & Riggs, 1991). There has been concern, however, that discomfort aroused by focusing on the trauma could be harmful in substance dependent patients, who might escalate substance use or flee treatment. At the same time, the demand for specific interventions for patients with trauma and substance abuse has been mounting in community-based treatment systems (Cohen, Dickow, Horner, Zweben, & Balabis, 2003;Morrissey et al.).To address this need, Najavits (2002) developed Seeking Safety (SS), anintegrated cognitive behavioral treatment of PTSD and substance use disorder. Thus far, SS has been researched in various studies including a multisite controlled trial with homeless women veterans (Desai, Harpaz-Rotem, Najavits, & Rosenheck, 2008); two randomized control trials with low-income urban women and adolescent girls (Hien, Cohen, Miele, Litt & Capstick, 2004;Najavits, Gallop, & Weiss, 2006);...

Review of group treatment for PTSD

“…The majority of the group treatment studies we reviewed are consistent with this recommendation; they tended to include six to eight participants per group [9,16,24]. However, there are some notable exceptions with somewhat smaller (e.g., 2 members [25]) and larger (e.g., 10-11 members [11,15]) groups represented in the literature. The type of group that is being conducted should be the primary factor in deciding the number of group members to allow.…”

“…One possible direction is to focus future research efforts on the treatments that have the largest effects. In Sloan et al's meta-analysis [27], the studies that had within-group effect sizes larger than 1.0 were Beck et al [25]. Of these, only Krupnick et al had a between-group effect size (d = 0.91) defined as large according to Cohen [44], but it was based on a wait list comparison condition and was substantially smaller than effect sizes reported for evidence-based individual treatments for PTSD when wait list comparison conditions are used [37].…”

“…All but one of these studies [12] found no significant between-group difference in PTSD symptom severity following treatment. However, most of these studies did find that PTSD symptom severity significantly decreased following treatment for both the therapeutic group and the nonspecific comparison condition [9,16,25,36]. Nonspecific comparison groups in combination with a wait list comparison group are helpful for interpreting the results of studies in which the treatments being compared do not differ from one another.…”

“…Of the 17 studies listed in Tables 1 and 2, 8 used a nonspecific comparison design. Typical nonspecific treatments in these studies included relaxation [12], psychoeducation [25,28], present-centered therapy [9,16], and treatment as usual [36]. All but one of these studies [12] found no significant between-group difference in PTSD symptom severity following treatment.…”

“…The studies reviewed were heterogeneous in terms of target therapy, comparison condition, PTSD outcome measure, and trauma sample. Of the 17 RCTs, 6 did not require a PTSD diagnosis for inclusion in the study and 2 examined a treatment that targeted symptoms other than PTSD [28][29] or focused on comorbid diagnoses such as human immunodeficiency virus diagnosis and substance abuse [25,[35][36]. We discuss these 17 studies next, with a focus on the methodological considerations that affect the interpretation of the findings.…”