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Abstract: Black women are at heightened risk for trauma exposure, post-traumatic stress disorder (PTSD), and substance use disorders (SUDs) compared to white women and the general population. However, disparities in treatment engagement and retention persist, particularly for Black women with co-occurring PTSD and SUD. Although therapeutic alliance is an important predictor and mediator of treatment retention and outcomes, we know little about predictors of alliance and the mediating role of alliance for PTSD+SUD outcomes among Black women. This study used data previously collected for the National Drug Abuse Treatment Clinical Trials Network (CTN) Women and Trauma Study (CTN-0015), which compared Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women’s Health Education (control). It includes 88 Black/African American women from both arms of the original trial. Measures included the Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale. Women in the intervention arm also completed the Seeking Safety Feedback Questionnaire. Stepwise, hierarchical linear regressions indicted that years of education and previous alcohol/drug treatment attempts significantly predicted early alliance in the second week of therapy, but not late alliance in the last week of therapy. Greater education and more treatment attempts were associated with higher early alliance. Alliance did not mediate relationships between these significant predictors and treatment outcomes (e.g., attendance, post-treatment PTSD and SUD symptoms) or treatment feedback in the Seeking Safety group. Conclusions: Education and prior treatment attempts predicted early alliance among Black/African American women in PTSD+SUD group treatment, and higher education level was associated with poorer Seeking Safety feedback topic ratings. Educational level and treatment history should be considered during alliance building in therapeutic interventions with Black women. Clinicians may consider the integration of pre-treatment alliance-building strategies with Black female patients who have lower levels of education. This study provides insight into the relative impact of several important factors that influence early alliance among Black women with co-occurring PTSD and SUD. Related protocols: CTN-0015

Abstract:

Despite advances toward integration of care for women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD), low abstinence rates following SUD/PTSD treatment remain the norm. The utility of investigating distinct substance use trajectories is a critical innovation in the detection and refining of effective interventions for this clinical population. The present study reanalyzed data from the largest randomized clinical trial to date for co-occurring SUD and PTSD in women (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders”). Randomized participants (n=353) received one of two interventions in addition to treatment as usual for SUD: 1) trauma-informed integrative treatment for PTSD/SUD (Seeking Safety); or 2) an active control psychoeducation course on women’s health (Women’s Health Education).

The present study utilized latent growth mixture models (LGMM) with multiple groups to estimate women’s substance use patterns during the 12-month follow-up period. Findings provided support for three different trajectories of substance use in the post-treatment year: 1) consistently low likelihood and use frequency; 2) consistently high likelihood and use frequency; and 3) high likelihood and moderate use frequency. Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not. Additionally, SUD severity, age, and after-care efforts were shown to be related to trajectory membership.

Conclusions: Findings highlight the necessity of accounting for heterogeneity in post-treatment substance use, relevance of trauma-informed care in SUD recovery, and benefits of incorporating methodologies like LGMM when evaluating SUD treatment outcomes. For women dually diagnosed with PTSD and SUD, the current study established the presence of several varied clinical presentations linked to substance use following treatment, each with potentially different needs, vulnerabilities, and strengths. Results of this study also point to opportunities for tailing interventions to the specific clinical presentation and potential impact of these choices on a woman’s trajectory of recovery.

Abstract:

This secondary analysis of data from National Drug Abuse Institute Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders,” investigated the impact of 12 sessions of Seeking Safety (SS) on reducing posttraumatic stress disorder (PTSD) symptoms in a sample of dually diagnosed women with physical disabilities versus nondisabled (ND) women. SS is an evidence-based and widely implemented manualized therapy for PTSD and/or substance use disorder. It is a present-focused model that promotes coping skills and psychoeducation. In CTN-0015, 353 participants with current PTSD and substance use disorder (SUD) were randomly assigned to partial-dose SS or Women’s Health Education (WHE) group therapy conducted in a community-based substance abuse treatment program. The women were categorized as participants with disabilities (PWD; n=20) or ND (n=333) based on the question, “Do you receive a pension for a physical disability?” PTSD was assessed with the Clinician-Administered PTSD Scale (CAPS) at baseline and follow-ups after treatment (1 week, 3 months, 6 months, and 12 months). PWD experienced sustained reductions in PTSD symptoms when treated with SS but not WHE. Indeed, PTSD symptoms of PWD in WHE returned to baseline levels of severity by 12-month follow-up. This pattern of results was not observed among ND women, who sustained improvements on PTSD in both treatment conditions.

Conclusions: These results suggest strong potential for using Seeking Safety to treat PTSD among women with physical disabilities, an intervention that may be particularly relevant for this population by providing a trauma focus without requiring clients to delve into painful traumatic memories and instead offering a present and optimistic focus on coping skills and education. This is a vulnerable population for whom trauma is bound up closely with disability; the finding here, that women with disabilities had better outcomes in the Seeking Safety group than the Women’s Health Education group, speaks to the genuine need to address trauma and PTSD more directly in those with disabilities.

Related protocols: CTN-0015

Abstract:

Given high drop-out rates and difficulties with retention among women in treatment for co-occurring post-traumatic stress disorder (PTSD) and substance use disorders (SUD), research to determine the specific conditions under which this population can best be engaged and benefit from treatment is important. This study examined the relationship between racial/ethnic match and treatment outcomes for 224 women who participated in a National Drug Abuse Treatment Clinical Trials Network (CTN) study of group treatments for posttraumatic stress disorder (PTSD) and substance use disorders, “Women’s Treatment for Trauma and Substance Use Disorders” (CTN-0015). Generalized estimating equations were used to examine the effect of client-therapist racial/ethnic match on outcomes.

Results revealed racial/ethnic match was not significantly associated with session attendance. There was a significant three-way interaction between client race/ethnicity, baseline level of PTSD symptoms, and racial/ethnic match on PTSD outcomes. White clients, with severe PTSD symptoms at baseline, who attended treatment groups where they were matched with their therapist, had greater reductions in PTSD symptoms at follow-up than their counterparts who were racially/ethnically mismatched with their group therapist. Racial/ethnic match did not confer additional benefits for black clients in terms of PTSD outcomes. Racial/ethnic match interacted with baseline substance use to differentially influence substance use outcomes at follow-up for all women.

Conclusions: Overall, these findings revealed the complexity of racial/ethnic matching between client and therapist and its impact, particularly within a group treatment context. While racial/ethnic matching may provide, in some circumstances, a context that facilitates understanding, enhances trust, and strengthens the alliance; under other conditions, racial/ethnic matching may not confer additional benefits. These findings highlight the need for further examinations into individual and subgroup differences in the benefits of racial/ethnic matching.

Related protocols: CTN-0015

Abstract:

This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015 (“Women’s Treatment for Trauma and Substance Use Disorders”) examined the associations between post-traumatic stress disorder (PTSD) symptoms, stimulant use, and treatment outcomes among dually diagnosed women. Participants were 141 women who participated in the original multisite clinical trial of group treatments for PTSD and addictions. Generalized linear models indicated Seeking Safety (SS, a cognitive-behavioral intervention) was significantly more effective than Women’s Health Education (WHE, a control group intervention) in reducing stimulant use at follow-up among women who were heavy stimulant users at pre-treatment and who showed improvements in PTSD symptoms. There were no significant differences between the interventions among women who were light stimulant users at treatment entry.

Conclusions: These findings add to the growing body of literature on the functional relationship between traumatic stress responses and substance use. Findings suggest that, among heavy stimulant users, integrated treatments that lead to PTSD symptom reductions can in turn improve stimulant use outcomes. This supports treatment models that address PTSD concurrently with substance use disorder treatment.

Related protocols: CTN-0015

Abstract:

This study examined in- and post-treatment mediation effects of a 12-session dose of Seeking Safety (SS) — an integrative cognitive behavioral treatment for comorbid PTSD and SUDs — on alcohol and cocaine outcomes in comparison to Women’s Health Education (WHE) in a seven-site randomized controlled effectiveness trial, CTN protocol 0015, “Women’s Treatment for Trauma and Substance Abuse.” Women (n=353) enrolled in outpatient substance abuse treatment, who had experienced multiple traumas in childhood and/or adulthood and who had comorbid PTSD, were randomly assigned to receive SS or WHE delivered in open enrollment groups for 12 sessions in 6 weeks (unlike the full 25-topic SS protocol). Data were analyzed under two forms of longitudinal mediation analysis, each accounting for changes over time in group membership and group context, respectively. Women in SS, compared to WHE, showed significantly steeper decreases in PTSD frequency and severity, which in turn showed significant impact in reducing both cocaine and alcohol use. This pattern was strongest for those who completed most of the treatment sessions, which was the majority of patients in the trial; these patterns only emerged during the in-treatment phase.

Conclusions: Use of an integrated approach to PTSD/SUD such as Seeking Safety can be helpful in more rapidly reducing PTSD, which consequently reduces SUD symptoms, particularly for those who attend most of the available treatment sessions. This is one of the first studies to illustrate such effects in treating comorbid PTSD and SUD in the context of a highly impaired population delivered by community-based providers.

Related protocols: CTN-0015

Abstract:

Epidemiologic studies have found that trauma-related disorders are ubiquitous among women in treatment for addictions. Evidence-based practices (EBP) for trauma among those with addictions have brought the field to an important stage: examining mechanistic questions such as how, for whom and when EBPs work best and learning how to implement EBPs in community treatment settings. The National Drug Abuse Treatment Clinical Trials Network “Women and Trauma” study, protocol CTN-0015, has contributed to this body of knowledge. With over 15 publications, none has yet provided an integrative overview of the findings. This presentation examines the contribution of this landmark multi-site psychotherapy trial through a review of primary and secondary analyses that highlight important aspects of patient centered outcomes.

From 2004-2005 in seven treatment programs, the study randomized 353 women into one of two 6-week treatment groups in addiction to treatment-as-usual: 1) Seeking Safety, a treatment for substance abuse and trauma, or 2) Women’s Health Education curriculum comparison group. Assessments were administered at baseline, weekly in treatment, and 3-, 6-, and 12-months post-treatment. In addition to primary and secondary findings, important mediators (e.g., therapeutic alliance, PTSD severity), moderators (e.g., participation in self-help recovery), individual characteristics (e.g., recovery management) and implementation issues (e.g., safety, racial/ethnic client-counselor matching, treatment participation) are discussed from both research and clinical perspectives.

Conclusions: In an era of patient-centered outcomes, new methods and creative analytic techniques are essential to maximize findings from clinical trials. Synthesizing the analyses from the Women and Trauma studies is presented as a model for how to approach interpreting research outcomes relevant to personalized medicine.

Related protocols: CTN-0015

Abstract:

Studies have shown strong associations between intimate partner violence (IPV) and both posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Despite these linkages, little is known about how PTSD-SUD treatment might influence IPV outcomes. The current study is a secondary analysis of a larger National Drug Abuse Treatment Clinical Trials Network (CTN) study exploring the effectiveness of two behavioral interventions for women with comorbid PTSD-SUD (protocol CTN-0015). Participants (n=288) were randomly assigned to Seeking Safety (SS), a cognitive-behavioral treatment that focuses on trauma and substance abuse symptoms, or to Women’s Health Education, a psychoeducational group. Logistic regressions were used to examine how treatment condition, identified risk factors, and their interactions were related to IPV. Results showed that participants who were abstinent at baseline were significantly less likely to experience IPV over the 12-month follow-up period, whereas participants living with someone with an alcohol problem were significantly more likely to experience IPV over follow-up. Findings also showed that at a trend level, participants with recent interpersonal trauma at baseline and higher total of lifetime trauma exposures were more likely to report IPV during follow-up. Although there was no main effect for treatment condition, a significant interaction between treatment condition and baseline abstinence was found. Participants who were abstinent at baseline and in the SS condition were significantly less likely to report IPV over follow-up.

Conclusions: These findings indicate that an integrated treatment for PTSD and SUD was associated with significantly better IPV outcomes for a subset of individuals. The possibility that women with PTSD-SUD may differentially benefit from SS has important clinical implications. Further research examining the intersection of PTSD, SUD, and IPV, and the impact of treatment on a range of outcomes is needed.

Related protocols: CTN-0015

Abstract:

Individuals with comorbid post-traumatic stress disorder (PTSD) and substance use disorders (SUD) are at greater risks for chronic health problems and report worse physical function than individuals with SUD alone. It is unknown if treatment that addresses PTSD and/or SUD can impact these health concerns. This poster reports on a secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network (CTN) study CTN-0015, exploring the impact of two treatments for women with trauma and SUD on health status perception.

Women meeting criteria for PTSD and alcohol and/or SUD (N=353) were randomized to either 12 biweekly group sessions of Seeking Safety, a trauma focused integrated SUD/PTSD treatment, or 12 biweekly group sessions of Women’s Health Education, an intervention focusing on gender-specific health issues. Women were assessed at baseline, 1, 12, 24, and 52 weeks post-intervention on questions from the medical subscale of the Addiction Severity Index and five questions inquiring about health status perception. Analysis found that 46% of women reported a chronic medical problem at baseline and 39% reported taking a prescribed medication for a medical problem. There were no main effects of time, group, or time-by-group interaction on measures of perceived health or number of days experiencing medical problems. Across the follow-up visits, women who experienced re-victimization (25%) reported having significantly more days of medical problems and worse perceived health than those women who did not report trauma during the follow-up.

Conclusions: Women with PTSD and SUD have physical health concerns that were not differentially affected by study treatments. Treatment for SUD and PTSD may be improved by addressing health concerns, particularly in women who experience re-victimization post-treatment.

Related protocols: CTN-0015

Abstract:

The co-occurrence of post-traumatic stress disorder (PTSD) with substance use disorder (SUD) is a challenging clinical presentation with a complicated etiologic pathway. Women’s reproductive history, especially adverse reproductive events, may represent an important set of factors predicting current health and health perceptions. In the National Drug Abuse Treatment Clinical Trials Network “Women and Trauma” study (protocol CTN-0015), 353 women (ages 18-65) with co-occurring PTSD and SUD were enrolled into a randomized controlled trial of 12 biweekly group sessions of either Seeking Safety, an integrated SUD/PTSD treatment, or Women’s Health Education. Women were assessed at baseline, 1, 12, 24, and 52 weeks post intervention on measures of perceived health. Researchers sought to characterize reproductive history in these women, and to examine its association with current health problems. Generalized estimating equations (GEE) were employed to account for the repeated health assessments.

Of 328 women providing baseline reproductive history, 93% had ever been pregnant. Of these, 32 (10.5%) reported giving birth to a child who died, 154 (50.5%) reported an abortion, 119 (39%) reported a miscarriage, 13 (4.3%) reported stillbirth, and 71 (23.4%) reported a premature infant who survived. Overall, 206 (62.8%) reported at least one of these events, and 177 (54%) reported at least one other than miscarriage. At follow-up visits, these 177 reported 3.1 more average days of medical problems in the last month, were more trouble by medical problems, were more likely to report that they had been feeling bad lately, and rated current health status more poorly than other women.

Conclusions: These findings suggest that women with a history of adverse reproductive events may be at increased risk for poor perceived health status. Treatment of PTSD and SUD in these women may be improved by consideration of adverse reproductive history.

Related protocols: CTN-0015

Abstract:

In this secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015 (“Women’s Treatment for Trauma and Substance Use Disorders”), researchers examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women’s Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions. Alliance was not related to substance use outcomes. In all, this study demonstrates that this typically challenging group of women can develop a strong therapeutic alliance within a relatively brief treatment episode in a group format, facilitating reductions in PTSD symptoms and leading to treatment retention.

Related protocols: CTN-0015

Abstract:

This study uses data from the largest effectiveness trial to date on treatment of co-occurring posttraumatic stress and substance use disorders (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015), applying advances in statistical methodology to model treatment attendance and membership turnover in rolling groups. Women receiving outpatient substance abuse treatment (N=353) were randomized to 12 sessions of Seeking Safety of a health education control condition (Women’s Health Education). Assessments were completed at baseline and at 1 week, 3, 6, and 12 months post-treatment. Outcome measures were alcohol and cocaine use in the prior 30 days captured using the Addiction Severity Index. Latent class pattern mixture modeling (LCPMM) was used to estimate attendance patterns and to test for treatment effects within and across latent attendance patterns and group membership turnover. Across LCPMM analyses for alcohol and cocaine use, similar treatment attendance patterns emerged: Completers never decreased below an 80% probability of attendance, droppers never exceeded a 41% probability of attendance, and titrators demonstrated a 50% to 80% probability of attendance. Among completers, there were significant decreases in alcohol use from baseline to 1-week post-treatment, followed by nonsignificant increases in alcohol during follow-up. No differences between treatment conditions were detected. Titrators in Seeking Safety had lower rates of alcohol use from 1-week through 12-month follow-up compared with control participants. Droppers had nonsignificant increases in alcohol during both study phases. Cocaine use findings were similar but did not reach significant levels.

Conclusions: The impact of client self-modulation of treatment dosage and group membership composition may influence behavioral treatment outcomes among this population. Providers should consider that female patients with comorbid PTSD and SUD may be in the best position to determine when, how often, or which sessions to attend; such perspectives might not only be empowering to patients but more efficacious as well.

Related protocols: CTN-0015

Abstract:

Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorders trials has received little attention. This paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. In the National Drug Abuse Treatment Clinical Trials Network study, protocol CTN-0015, a multi-site trial evaluating Seeking Safety (SS) relative to Women’s Health Education (WHE) for women with co-occurring PTSD and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106) which recruited participants from newspaper advertising and clinic intakes, were analyzed. Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase.

In conclusion, recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants.

Related protocols: CTN-0015

Abstract:

The results of protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders,” found that the intervention, “Seeking Safety,” a structured cognitive-behavioral treatment that addresses trauma/post-traumatic stress disorder and substance abuse, was no more effective at reducing PTSD symptom severity than Women’s Health Education, the control curriculum (which did not specifically address PTSD). There were also no significant changes in baseline to one-year follow-up for either group in terms of substance use.

These results were contrary to prior research and difficult to interpret. This commentary article offers several possible explanations. One possible conclusion is that Seeking Safety does not have specific elements that address PTSD any more effectively than Women’s Health Education, which supposedly had none. As such, the study conclusions are consisted with a large literature where failures to differentiate active psychotherapy interventions are common. A second possibility is that Women’s Health Education contains as-yet-unidentified active ingredients as effective as those in Seeking Safety at treating symptoms of PTSD. Additional research is required to determine the effectiveness of Seeking Safety and other trauma/PTSD interventions in treating co-occurring PTSD and substance abuse within the primary substance abuse treatment system.

Related protocols: CTN-0015

Abstract:

Post-traumatic stress disorder (PTSD) is a common co-morbidity in the substance use disorder (SUD) population. It is estimated that 80% of women in treatment for SUD have suffered physical, emotional, or sexual trauma, and that they present special needs that affect their success in achieving the goals of addictions treatment.

Protocol CTN-0015 compared a trauma-directed behavioral therapy, Seeking Safety (SS), to a more general behavioral intervention, Women’s Health Education. Both treatments reduced PTSD symptoms and drug use; however, secondary analyses are beginning to reveal differences among subtypes of participants in the effectiveness of the two approaches, which have significant clinical implications. This presentation features a comprehensive overview to the best approaches for treating women with co-occurring PTSD and SUD.

Related protocols: CTN-0015