Frequency and type of adverse events associated with treating women with trauma in community...
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Frequency and type of adverse events associated with treating women with trauma in community substance abuse treatment programs T. KIlleen 1 , C. Brown 2 , A. Campbell 3 , H. Jiang 3 , R. Sampson 1 , E. Nunes 3 , D. Hien 3 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 abuse treatment have a history of trauma and meet criteria for Post Traumatic Stress Disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. The NIDA Clinical Trials Network (CTN) recently completed a national multi-site randomized controlled study with 353 women who met criteria for either full or threshold PTSD and a substance use disorder (SUD). Design: Eligible women who were enrolled in substance abuse treatment received either 12 sessions of Seeking Safety (SS), a PTSD specific intervention, or 12 sessions of a women’s health education intervention (WHE). All women were enrolled in treatment as usual at the community substance abuse programs. Both substance abuse and PTSD outcomes were assessed post intervention at 7 weeks and at 3, 6, and 12 months. Participants were monitored on a weekly basis throughout the study intervention for the occurrence of any adverse events (AEs). Analyses: Descriptive statistics were used to explore the frequency and type of AEs. Independent sample t-test for continuous variables and Chi-square for categorical variables were used to examine study safety across treatment groups. Results: Forty-nine (17%) of 291 women reported study related AEs throughout the study intervention and 7 week post intervention follow-up. There were no significant between group differences in the number of women who reported AEs (9% for SS, 7% for WHE; p = 0.3). The average number of study related AEs per participant reporting any AE was 1.5 (0.9) for the SS group and 2.0 (1.2) for the WHE group (p = 0.3). The most common study related AEs were worsening of PTSD and depressive symptoms, but differences were not significant between groups. Conclusion: Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms. Methods Acknowledgements ● Integrated PTSD and SUD treatments are increasingly being implemented in community treatment programs. The traditional prevailing thought that individuals with comorbid PTSD and SUD could not tolerate trauma treatment without relapse to drugs has been challenged. ● There is little information looking at the safety of integrated treatments such as Seeking Safety, a non-exposure treatment for women with trauma and SUD, within large randomized controlled studies. ● The present study evaluated data from the Clinical Trials Network to determine if women receiving an integrated treatment for trauma and SUD, Seeking Safety, experienced more adverse events than women receiving a women’s health education intervention, and whether or not these adverse events were associated with reduced session attendance and/or treatment attrition. The present study is a secondary analysis of a NIDA CTN study investigating the effectiveness of treatment for trauma and SUD in women presenting for treatment at community treatment programs across the United States. Participants Participants were female outpatients at seven psychosocial community treatment programs affiliated with the CTN. Participants were enrolled between 2004 and 2006. In total, 353 participants were randomized to receive 12 bi- weekly group sessions of either Seeking Safety or Women’s Health Education. Outcome Definitions Women were interviewed weekly regarding any new adverse events or change in severity of adverse events while enrolled in the intervention. Potential study-related adverse events were defined as any increase in PTSD symptoms, depression or substance use. Adverse advents reported throughout the intervention phase (after first session to one week past last session) of the study were included in this analysis. There were 291 women evaluated for adverse events during the intervention phase. Statistical Analysis The demographic and diagnostic characteristics at baseline, the number of participants experiencing new study related adverse events within the treatment and the severity of the new study related AEs were compared across two treatment groups with Chi-square test for categorical variables and t-test for continuous variables. Wilcoxon rank test was used to compare the number of new study- related adverse events per patient between two treatment arms. The association between the number of sessions attended and the number of new study- related adverse events within treatment was estimated and tested by fitting a log-linear model for the number of participant AEs 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 with trauma and substance use disorders receiving a trauma focused intervention did not experience any more treatment- related adverse events than women receiving a health education intervention. ● Implementing a trauma focused intervention such as Seeking Safety also did not differentially affect intervention session attendance and did not result in women leaving treatment prematurely. ● The relatively small percentage of adverse events involving an increase in substance use suggests that women did not necessarily use substances to cope with increases in PTSD/depressive symptoms. ● Validating safety concerns associated with integrated treatments for trauma and substance use disorders will also increase clinician acceptability of such interventions. ● The sample description is displayed in Table 1. Participants were mostly Caucasian, divorced or separated, unemployed and cocaine dependence was the primary substance use disorder. There were no between group differences on demographics, substance use diagnoses or trauma symptom severity. ● Figure 1 displays adverse event descriptions. Over half of the study related adverse events involved worsening of PTSD symptoms or increase in depression. Only 10% of participants reported increase in substance use. ● Table 2 displays the total new adverse events, serious adverse events and study-related adverse events. Only 17% of the women experienced study- related adverse events. The percentage of women experiencing study-related adverse events was not different between the two treatment groups (p = 0.3). ● There were no between group differences with regard to number of adverse events experienced and length of time completing treatment (p = 0.3). ● There was a significant effect of the number of attended sessions on the number of new study- related adverse events (N=83). The more sessions the participants attended, the more study-related adverse events experienced (p = 0.01). However, there were no significant differences between the two treatment groups. Understandably, women attending more sessions have more opportunities to report AEs. Table 1 Demographic, Substance Use Diagnoses and Trauma Information NIDA Clinical Trials Network Table 2 Adverse Events (AEs) Experienced During Treatment Intervention Phase A dverse EventD escriptions Other Depressive sym ptom s Anxiety/panic Increased substance use W orsening PTSD Frequency 40 30 20 10 0 6 25 13 8 31 A dverse EventD escriptions Figure 1 New AEs = A lladverse eventsregardlessofrelationship to study interventions N ew Serious A Es= A dverse eventsresulting in hospitalization orsignificantim pairm ent N ew Study R elated A Es= A dverse eventsrelated to the interventionsasdefined in the protocol Total S eeking Safety W omen's Health P value Total # 190 79 111 # distinctparticipants 110 51 59 0.4 New AEs Average # 1.73 1.55 1.88 0.2 Total # 35 12 23 # distinctparticipants 27 10 17 0.2 N ew S erious AEs Average # 1.3 1.2 1.35 0.6 Total # 83 42 41 # distinctparticipants 49 28 21 0.3 N ew S tudy- R elated AEs Average # 1.69 1.5 1.95 0.3 mild 22 14 8 moderate 60 28 32 S tudy-related AE S everity severe 1 0 1 0.2 Variables Total N =353 Seeking Safety N =176 W om en's Health N =177 P value A ge 39.2 (9.3) 39.4 (9.5) 39.0 (9.1) 0.7 Ethnicity 0.2 A frican Am erican 33.99% 32.95% 35.03% C aucasian 45.61% 47.16% 44.07% Latina 6.52% 3.98% 9.04% A frican Indian 0.28% 0.57% O ther 0.28% 0.56% M ulti_Racial 13.31% 15.34% 11.30% MaritalStatus 0.4 Married 17.56% 14.77% 20.34% Single 36.83% 37.50% 36.16% D iv/Sep 45.61% 47.73% 43.50% Education 12.5 (2.4) 12.7 (2.3) 12.4 (2.6) 0.4 Em ployment 0.9 Employed 40.23% 40.34% 40.11% Unem ployed 54.96% 54.55% 55.37% Student_R etired_D isabled 4.82% 5.11% 4.52% Substance U se D iagnosis (currentdependence) Cocaine 70.45% 72.73% 68.18% 0.3 Stimulants 7.65% 8.52% 6.78% 0.4 Opiates 25.57% 25.57% 25.57% 0.6 Marijuana 27.20% 27.84% 26.55% 0.4 A lcohol 56.09% 59.66% 52.54% 0.4 #days used in past30 Am phetamine_30day 0.45 (3.29) 0.61 (3.76) 0.29 (2.74) 0.4 H eroin_30day 0.19 (1.69) 0.23 (2.3) 0.14 (0.70) 0.6 O ther_O piate_30day 1.25 (4.55) 1.21 (4.18) 1.29 4.91) 0.9 A lcohol_30day 2.87 (6.56) 3.33 (6.95) 2.41 (6.13) 0.2 Marijuna_30day 2.65 (7.06) 2.85 (7.11) 2.44 (7.02) 0.6 C ocaine_30day 4.24 (8.1) 4.39 (8.09) 4.10 (8.12) 0.7 Total_C APS_Severity 62.87 (19.4) 61.56 (19.36) 64.16 (19.4) 0.8
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Transcript of Frequency and type of adverse events associated with treating women with trauma in community...
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 abuse treatment have a history of trauma and meet criteria for Post Traumatic Stress Disorder (PTSD). Fear regarding the extent to which PTSD treatment can evoke negative consequences remains a research question. The NIDA Clinical Trials Network (CTN) recently completed a national multi-site randomized controlled study with 353 women who met criteria for either full or threshold PTSD and a substance use disorder (SUD). Design: Eligible women who were enrolled in substance abuse treatment received either 12 sessions of Seeking Safety (SS), a PTSD specific intervention, or 12 sessions of a women’s health education intervention (WHE). All women were enrolled in treatment as usual at the community substance abuse programs. Both substance abuse and PTSD outcomes were assessed post intervention at 7 weeks and at 3, 6, and 12 months. Participants were monitored on a weekly basis throughout the study intervention for the occurrence of any adverse events (AEs). Analyses: Descriptive statistics were used to explore the frequency and type of AEs. Independent sample t-test for continuous variables and Chi-square for categorical variables were used to examine study safety across treatment groups. Results: Forty-nine (17%) of 291 women reported study related AEs throughout the study intervention and 7 week post intervention follow-up. There were no significant between group differences in the number of women who reported AEs (9% for SS, 7% for WHE; p = 0.3). The average number of study related AEs per participant reporting any AE was 1.5 (0.9) for the SS group and 2.0 (1.2) for the WHE group (p = 0.3). The most common study related AEs were worsening of PTSD and depressive symptoms, but differences were not significant between groups. Conclusion: Implementing PTSD treatment in substance abuse treatment programs appears to be safe, with minimal impact on intervention-related adverse psychiatric and substance abuse symptoms.
Methods
Acknowledgements
● Integrated PTSD and SUD treatments are increasingly being implemented in community treatment programs. The traditional prevailing thought that individuals with comorbid PTSD and SUD could not tolerate trauma treatment without relapse to drugs has been challenged.
● There is little information looking at the safety of integrated treatments such as Seeking Safety, a non-exposure treatment for women with trauma and SUD, within large randomized controlled studies.
● The present study evaluated data from the Clinical Trials Network to determine if women receiving an integrated treatment for trauma and SUD, Seeking Safety, experienced more adverse events than women receiving a women’s health education intervention, and whether or not these adverse events were associated with reduced session attendance and/or treatment attrition.
The present study is a secondary analysis of a NIDA CTN study investigating the effectiveness of treatment for trauma and SUD in women presenting for treatment at community treatment programs across the United States.
Participants
Participants were female outpatients at seven psychosocial community treatment programs affiliated with the CTN. Participants were enrolled between 2004 and 2006. In total, 353 participants were randomized to receive 12 bi-weekly group sessions of either Seeking Safety or Women’s Health Education.
Outcome Definitions
Women were interviewed weekly regarding any new adverse events or change in severity of adverse events while enrolled in the intervention. Potential study-related adverse events were defined as any increase in PTSD symptoms, depression or substance use. Adverse advents reported throughout the intervention phase (after first session to one week past last session) of the study were included in this analysis. There were 291 women evaluated for adverse events during the intervention phase.
Statistical Analysis
The demographic and diagnostic characteristics at baseline, the number of participants experiencing new study related adverse events within the treatment and the severity of the new study related AEs were compared across two treatment groups with Chi-square test for categorical variables and t-test for continuous variables. Wilcoxon rank test was used to compare the number of new study-related adverse events per patient between two treatment arms. The association between the number of sessions attended and the number of new study- related adverse events within treatment was estimated and tested by fitting a log-linear model for the number of participant AEs 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 with trauma and substance use disorders receiving a trauma focused intervention did not experience any more treatment- related adverse events than women receiving a health education intervention.
● Implementing a trauma focused intervention such as Seeking Safety also did not differentially affect intervention session attendance and did not result in women leaving treatment prematurely.
● The relatively small percentage of adverse events involving an increase in substance use suggests that women did not necessarily use substances to cope with increases in PTSD/depressive symptoms.
● Validating safety concerns associated with integrated treatments for trauma and substance use disorders will also increase clinician acceptability of such interventions.
● The sample description is displayed in Table 1. Participants were mostly Caucasian, divorced or separated, unemployed and cocaine dependence was the primary substance use disorder. There were no between group differences on demographics, substance use diagnoses or trauma symptom severity.
● Figure 1 displays adverse event descriptions. Over half of the study related adverse events involved worsening of PTSD symptoms or increase in depression. Only 10% of participants reported increase in substance use.
● Table 2 displays the total new adverse events, serious adverse events and study-related adverse events. Only 17% of the women experienced study-related adverse events. The percentage of women experiencing study-related adverse events was not different between the two treatment groups (p = 0.3).
● There were no between group differences with regard to number of adverse events experienced and length of time completing treatment (p = 0.3).
● There was a significant effect of the number of attended sessions on the number of new study-related adverse events (N=83). The more sessions the participants attended, the more study-related adverse events experienced (p = 0.01). However, there were no significant differences between the two treatment groups. Understandably, women attending more sessions have more opportunities to report AEs.
Table 1 Demographic, Substance Use Diagnoses and Trauma Information
NIDA Clinical Trials Network
Table 2 Adverse Events (AEs) Experienced During Treatment Intervention Phase
Adverse Event Descriptions
OtherDepressive symptoms
Anxiety/panicIncreased substance use
Worsening PTSD
Fre
qu
en
cy
40
30
20
10
0
6
25
13
8
31
Adverse Event DescriptionsFigure 1
New AEs = All adverse events regardless of relationship to study interventions New Serious AEs = Adverse events resulting in hospitalization or significant impairment New Study Related AEs = Adverse events related to the interventions as defined in the protocol
Total Seeking Safety
Women's Health
P value
Total #
190
79
111
# distinct participants 110 51 59 0.4
New AEs
Average # 1.73 1.55 1.88 0.2
Total #
35
12
23
# distinct participants 27 10 17 0.2
New Serious
AEs Average # 1.3 1.2 1.35 0.6
Total #
83
42
41
# distinct participants 49 28 21 0.3
New Study- Related AEs
Average # 1.69 1.5 1.95 0.3
mild 22 14 8 moderate 60 28 32
Study-related
AE Severity
severe 1 0 1 0.2
Variables Total N=353
Seeking Safety N=176
Women's Health N=177
P value
Age 39.2 (9.3) 39.4 (9.5) 39.0 (9.1) 0.7 Ethnicity 0.2 African American 33.99% 32.95% 35.03% Caucasian 45.61% 47.16% 44.07% Latina 6.52% 3.98% 9.04% African Indian 0.28% 0.57% Other 0.28% 0.56% Multi_Racial 13.31% 15.34% 11.30% Marital Status 0.4 Married 17.56% 14.77% 20.34% Single 36.83% 37.50% 36.16% Div/Sep 45.61% 47.73% 43.50% Education 12.5 (2.4) 12.7 (2.3) 12.4 (2.6) 0.4 Employment 0.9 Employed 40.23% 40.34% 40.11% Unemployed 54.96% 54.55% 55.37% Student_Retired_Disabled 4.82% 5.11% 4.52% Substance Use Diagnosis (current dependence) Cocaine 70.45% 72.73% 68.18% 0.3 Stimulants 7.65% 8.52% 6.78% 0.4 Opiates 25.57% 25.57% 25.57% 0.6 Marijuana 27.20% 27.84% 26.55% 0.4 Alcohol 56.09% 59.66% 52.54% 0.4 #days used in past 30 Amphetamine_30day 0.45 (3.29) 0.61 (3.76) 0.29 (2.74) 0.4 Heroin_30day 0.19 (1.69) 0.23 (2.3) 0.14 (0.70) 0.6 Other_Opiate_30day 1.25 (4.55) 1.21 (4.18) 1.29 4.91) 0.9 Alcohol_30day 2.87 (6.56) 3.33 (6.95) 2.41 (6.13) 0.2 Marijuna_30day 2.65 (7.06) 2.85 (7.11) 2.44 (7.02) 0.6 Cocaine_30day 4.24 (8.1) 4.39 (8.09) 4.10 (8.12) 0.7
Total_CAPS_Severity
62.87 (19.4)
61.56 (19.36)
64.16 (19.4)
0.8
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