Transcript Open slide - CTN Dissemination Library

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
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 Chisquare 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.
Background and Rationale
● 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.
Methods
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 studyrelated 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.
● 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.
Figure 1
Adverse Event Descriptions
40
30
Frequency
● 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.
Results
20
31
25
10
● 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).
Table 2
Adverse Events (AEs) Experienced During
Treatment Intervention Phase
Total
Seeking
Safety
Women's
Health
Total #
# distinct participants
Average #
190
110
1.73
79
51
1.55
111
59
1.88
0.4
0.2
New Serious
AEs
Total #
# distinct participants
Average #
35
27
1.3
12
10
1.2
23
17
1.35
0.2
0.6
New StudyRelated AEs
Total #
# distinct participants
Average #
83
49
1.69
42
28
1.5
41
21
1.95
0.3
0.3
22
60
1
14
28
0
8
32
1
0.2
New AEs
Study-related
AE Severity
mild
moderate
severe
● 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
Variables
Age
Ethnicity
African American
Caucasian
Latina
African Indian
Other
Multi_Racial
Marital Status
Married
Single
Div/Sep
Education
Employment
Employed
Unemployed
Student_Retired_Disabled
Substance Use Diagnosis
(current dependence)
Cocaine
Stimulants
Opiates
Marijuana
Alcohol
#days used in past 30
Amphetamine_30day
Heroin_30day
Other_Opiate_30day
Alcohol_30day
Marijuna_30day
Cocaine_30day
Total
N=353
Seeking
Safety
N=176
Women's Health
N=177
39.2 (9.3)
39.4 (9.5)
39.0 (9.1)
33.99%
45.61%
6.52%
0.28%
0.28%
13.31%
32.95%
47.16%
3.98%
0.57%
35.03%
44.07%
9.04%
15.34%
P value
0.7
0.2
0.56%
11.30%
0.4
17.56%
36.83%
45.61%
12.5 (2.4)
14.77%
37.50%
47.73%
12.7 (2.3)
20.34%
36.16%
43.50%
12.4 (2.6)
40.23%
54.96%
4.82%
40.34%
54.55%
5.11%
40.11%
55.37%
4.52%
70.45%
7.65%
25.57%
27.20%
56.09%
72.73%
8.52%
25.57%
27.84%
59.66%
68.18%
6.78%
25.57%
26.55%
52.54%
0.3
0.4
0.6
0.4
0.4
0.45 (3.29)
0.19 (1.69)
1.25 (4.55)
2.87 (6.56)
2.65 (7.06)
4.24 (8.1)
0.61 (3.76)
0.23 (2.3)
1.21 (4.18)
3.33 (6.95)
2.85 (7.11)
4.39 (8.09)
0.29 (2.74)
0.14 (0.70)
1.29 4.91)
2.41 (6.13)
2.44 (7.02)
4.10 (8.12)
0.4
0.6
0.9
0.2
0.6
0.7
62.87 (19.4)
61.56 (19.36)
64.16 (19.4)
0.4
0.9
13
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
Conclusion
● In this large randomized multi-site study, women with
trauma and substance use disorders receiving a trauma
focused intervention did not experience any more treatmentrelated 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.
Acknowledgements
8
6
0
Worsening PTSD
Increased
substance use
Anxiety/panic
Depressive
symptoms
Adverse Event Descriptions
Other
P value
Total_CAPS_Severity
0.8
NIDA Clinical Trials Network