Aimee Campbell

Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis From a Randomized Clinical Trial in NIDA's Clinical Trials Network

OBJECTIVE The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. METHOD Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the studys treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. RESULTS Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. CONCLUSIONS PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.

Multisite Randomized Trial of Behavioral Interventions for Women With Co-Occurring PTSD and Substance Use Disorders

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Womens Health Education [WHE]) within the National Institute on Drug Abuses Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment 1 week and 3, 6, and 12 months posttreatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS), the PTSD Symptom Scale-Self Report (PSS-SR), and a substance use inventory (self-reported abstinence and percentage of days of use over 7 days). 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. Study results do not favor Seeking Safety over WHE as an adjunct to substance use disorder treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions.

Effectiveness of HIV/STD Sexual Risk Reduction Groups for Women in Substance Abuse Treatment Programs : Results of NIDA Clinical Trials Network Trial

Context:Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. Objective:To test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. Design:Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months. Participants:Women recruited from 12 methadone or psychosocial treatment programs in Clinical Trials Network of National Institute on Drug Abuse. Five hundred fifteen women with ≥1 unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. Interventions:In SSB, five 90-minute groups used problem solving and skills rehearsal to increase HIV/STD risk awareness, condom use, and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. Main Outcome:Number of USOs at follow-up. Results:A significant difference in mean USOs was obtained between SSB and HE over time (F = 67.2, P < 0.0001). At 3 months, significant decrements were observed in both conditions. At 6 months, SSB maintained the decrease and HE returned to baseline (P < 0.0377). Women in SSB had 29% fewer USOs than those in HE. Conclusions:Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.

Internet-Delivered Treatment for Substance Abuse: A Multisite Randomized Controlled Trial

OBJECTIVE Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. METHOD Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment. RESULTS Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68). CONCLUSIONS Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.

The Impact of Trauma-Focused Group Therapy upon HIV Sexual Risk Behaviors in the NIDA Clinical Trials Network “Women and Trauma” Multi-Site Study

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA’s Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women’s health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

The role of alcohol misuse in PTSD outcomes for women in community treatment: A secondary analysis of NIDA's Women and Trauma Study

BACKGROUND Individuals with comorbid substance use and posttraumatic stress disorder may differentially benefit from integrated trauma-focused interventions based on specific presenting characteristics such as substance use type and PTSD severity. The current study is a secondary analysis of a NIDA Clinical Trials Network study exploring the effectiveness of two interventions for women with comorbid PTSD and substance use disorders. METHOD Generalized estimating equations were used to examine the association of baseline alcohol misuse with PTSD outcome measures over time for all randomized participants. RESULTS Women entering treatment with baseline alcohol misuse had higher Post Traumatic Stress Disorder Symptom Scale (PSS-SR) total scores (t=2.43, p<.05), cluster C (avoidance/numbing) scores (t=2.63, p<.01), and cluster D (hyper-arousal) scores (t=2.31, p<.05). For women with alcohol misuse, after treatment week 1, PSS-SR scores were significantly lower in the Seeking Safety intervention during treatment (chi(2)(1)=4.00, p<.05) and follow-up (chi(2)(1)=4.87, p<.05) compared to those in the health education intervention. Alcohol misusers in the Seeking Safety group who had higher baseline hyper-arousal severity improved more quickly than those with lower baseline hyper-arousal severity during treatment (chi(2)(1)=4.06, p<.05). CONCLUSIONS These findings suggest that the type of substance abuse at treatment entry may inform treatment selection, predict treatment response among those with co-occurring PTSD and substance use disorders, and indicate a more severe clinical picture.

Relationship Power and Sexual Risk among Women in Community-Based Substance Abuse Treatment

Relationship power has been highlighted as a major factor influencing women’s safer sex practices. Little research, however, has specifically examined relationship power in drug-involved women, a population with increased risk for HIV transmission. Using baseline data from a National Institute on Drug Abuse Clinical Trials Network multisite trial of a women’s HIV prevention intervention in community-based drug treatment programs, this paper examined the association between sexual relationship power and unprotected vaginal or anal sex. The Sexual Relationship Power Scale, a measure of relationship control and decision-making dominance, was used to assess the association between power and unprotected sex in relationships with primary male partners. It was hypothesized that increased relationship power would be associated with decreased unprotected sexual occasions, after controlling for relevant empirical and theoretical covariates. Findings show a more complex picture of the association between power and sexual risk in this population, with a main effect in the hypothesized direction for decision-making dominance but not for relationship control. Possible explanations for these findings are discussed, and future research directions for examining power constructs and developing interventions targeting relationship power among drug-involved women are suggested.

Design and Methodological Considerations of an Effectiveness Trial of a Computer-assisted Intervention: An Example from the NIDA Clinical Trials Network

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuses (NIDAs) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.

Substance Use and High Risk Sexual Behaviors among Women in Psychosocial Outpatient and Methadone Maintenance Treatment Programs

Objectives: The purpose of the present study was to assess the association between substance use/diagnosis and sexual risk behaviors among women enrolled in both psychosocial outpatient (PS) and methadone maintenance (MM) treatment and involved in a HIV prevention intervention study within the National Institute for Drug Abuse Clinical Trials Network. Methods: 515 sexually active women reported on unprotected sexual occasions (USO), anal sex, sex trading, sex with drug occasions, and multiple male sex partners at the baseline assessment. Results: Within the PS sample, cocaine use diagnosis was associated with more than twice the risk of having multiple partners, trading sex for drugs, having anal sex, or having sex with drugs; alcohol or opioid use diagnosis was associated with fewer risk behaviors. Within the MM sample, cocaine use, alcohol use and opiate use diagnoses were each associated with one to two risk behaviors. Associations between sexual risk and substance using days were less frequent in both samples. Conclusions: These findings highlight the need for integration of HIV sexual prevention interventions that address the relationship between sexual risk behavior and substance use diagnoses into substance abuse treatment programs.

Intimate Partner Violence Outcomes in Women with PTSD and Substance Use: A Secondary Analysis of NIDA Clinical Trials Network “Women and Trauma” Multi-Site Study

Studies have shown strong associations between intimate partner violence (IPV) and both posttraumatic stress disorder (PTSD) and substance use disorders (SUD). Despite these linkages, research on the dual diagnosis of PTSD-SUD and its relationship to IPV is in an early stage, and little is known about how PTSD-SUD treatment might influence IPV outcomes. The current study is a secondary analysis of a larger NIDA Clinical Trials Network study exploring the effectiveness of two behavioral interventions for women with comorbid PTSD-SUD. Participants (n=288) were randomly assigned to Seeking Safety (SS), a cognitive-behavioral treatment that focuses on trauma and substance abuse symptoms, or to Womens 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. 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.