Frequency and type of adverse events associated with treating women with trauma in community substance abuse treatment programs
T. KIlleen1, C. Brown2, A. Campbell3, H. Jiang3, R. Sampson1, E. Nunes3, D. Hien3
1 Medical University of South Carolina, Charleston, SC, USA.2 Charleston Center, Charleston, SC, USA.3 Columbia University, New York, NY, USA.
Abstract
Results
Conclusion
Background: A substantial number of women who enter substance abusetreatment have a history of trauma and meet criteria for Post TraumaticStress Disorder (PTSD). Fear regarding the extent to which PTSDtreatment can evoke negative consequences remains a researchquestion. The NIDA Clinical Trials Network (CTN) recently completed anational multi-site randomized controlled study with 353 women who metcriteria for either full or threshold PTSD and a substance use disorder(SUD). Design: Eligible women who were enrolled in substance abusetreatment received either 12 sessions of Seeking Safety (SS), a PTSDspecific intervention, or 12 sessions of a women’s health educationintervention (WHE). All women were enrolled in treatment as usual at thecommunity substance abuse programs. Both substance abuse and PTSDoutcomes were assessed post intervention at 7 weeks and at 3, 6, and 12months. Participants were monitored on a weekly basis throughout thestudy intervention for the occurrence of any adverse events (AEs).Analyses: Descriptive statistics were used to explore the frequency andtype of AEs. Independent sample t-test for continuous variables and Chi-square for categorical variables were used to examine study safety acrosstreatment groups. Results: Forty-nine (17%) of 291 women reported studyrelated AEs throughout the study intervention and 7 week postintervention follow-up. There were no significant between groupdifferences in the number of women who reported AEs (9% for SS, 7% forWHE; p = 0.3). The average number of study related AEs per participantreporting any AE was 1.5 (0.9) for the SS group and 2.0 (1.2) for the WHEgroup (p = 0.3). The most common study related AEs were worsening ofPTSD and depressive symptoms, but differences were not significantbetween groups. Conclusion: Implementing PTSD treatment in substanceabuse treatment programs appears to be safe, with minimal impact onintervention-related adverse psychiatric and substance abuse symptoms.
Methods
Acknowledgements
● Integrated PTSD and SUD treatments are increasingly beingimplemented in community treatment programs. The traditionalprevailing thought that individuals with comorbid PTSD and SUDcould not tolerate trauma treatment without relapse to drugs hasbeen challenged.
● There is little information looking at the safety of integratedtreatments such as Seeking Safety, a non-exposure treatment forwomen with trauma and SUD, within large randomized controlledstudies.
● The present study evaluated data from the Clinical TrialsNetwork to determine if women receiving an integrated treatmentfor trauma and SUD, Seeking Safety, experienced more adverseevents than women receiving a women’s health educationintervention, and whether or not these adverse events wereassociated with reduced session attendance and/or treatmentattrition.
The present study is a secondary analysis of a NIDA CTNstudy investigating the effectiveness of treatment for traumaand SUD in women presenting for treatment at communitytreatment programs across the United States.
Participants
Participants were female outpatients at seven psychosocialcommunity treatment programs affiliated with the CTN.Participants were enrolled between 2004 and 2006. In total,353 participants were randomized to receive 12 bi-weeklygroup sessions of either Seeking Safety or Women’s HealthEducation.
Outcome Definitions
Women were interviewed weekly regarding any new adverseevents or change in severity of adverse events while enrolled inthe intervention. Potential study-related adverse events weredefined as any increase in PTSD symptoms, depression orsubstance use. Adverse advents reported throughout theintervention phase (after first session to one week past lastsession) of the study were included in this analysis. There were291 women evaluated for adverse events during theintervention phase.
Statistical Analysis
The demographic and diagnostic characteristics at baseline,the number of participants experiencing new study relatedadverse events within the treatment and the severity of the newstudy related AEs were compared across two treatment groupswith Chi-square test for categorical variables and t-test forcontinuous variables. Wilcoxon rank test was used to comparethe number of new study-related adverse events per patientbetween two treatment arms. The association between thenumber of sessions attended and the number of new study-related adverse events within treatment was estimated andtested by fitting a log-linear model for the number of participantAEs with the number of sessions and treatment as predictors.All tests were two-sided and performed at the significance level=0.05.
Background and Rationale
● In this large randomized multi-site study, women withtrauma and substance use disorders receiving a traumafocused intervention did not experience any more treatment-related adverse events than women receiving a healtheducation intervention.
● Implementing a trauma focused intervention such asSeeking Safety also did not differentially affect interventionsession attendance and did not result in women leavingtreatment prematurely.
● The relatively small percentage of adverse eventsinvolving an increase in substance use suggests that womendid not necessarily use substances to cope with increases inPTSD/depressive symptoms.
● Validating safety concerns associated with integratedtreatments for trauma and substance use disorders will alsoincrease clinician acceptability of such interventions.
● The sample description is displayed in Table 1. Participants weremostly Caucasian, divorced or separated, unemployed and cocainedependence was the primary substance use disorder. There were nobetween group differences on demographics, substance usediagnoses or trauma symptom severity.
● Figure 1 displays adverse event descriptions. Over half of the studyrelated adverse events involved worsening of PTSD symptoms orincrease in depression. Only 10% of participants reported increase insubstance use.
● Table 2 displays the total new adverse events, serious adverseevents and study-related adverse events. Only 17% of the womenexperienced study-related adverse events. The percentage of womenexperiencing study-related adverse events was not different betweenthe two treatment groups (p = 0.3).
● There were no between group differences with regard to number ofadverse events experienced and length of time completing treatment(p = 0.3).
● There was a significant effect of the number of attended sessions onthe number of new study-related adverse events (N=83). The moresessions the participants attended, the more study-related adverseevents experienced (p = 0.01). However, there were no significantdifferences between the two treatment groups. Understandably,women attending more sessions have more opportunities to reportAEs.
Table 1 Demographic, Substance Use Diagnoses
and Trauma Information
NIDA Clinical Trials Network
Table 2 Adverse Events (AEs) Experienced During
Treatment Intervention Phase
Figure 1
