To test the effectiveness of the psychotherapy "Seeking Safety" in a Dutch SUD sample.
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
middelenafhankelijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter for the inpatient study is the effect of Seeking
Safety on trauma related symptoms, as measured by the Self-report inventory for
PTSD (SRIP). For the outpatients the main outcome measure will be substance use
severity, as measured by the EuropASI.
Secondary outcome
Secundairy outcome measures will focus on abstinence, craving, self-efficacy,
coping-skills and quality of life. Also, the influence of personality on
treatment outcome will be measured, whether the effects last for a prolonged
period and whether the intervention has an influence on drop-out rates.
Background summary
The high comorbidity of substance use disorders and posttraumatic stress
disorder (PTSD) has been widely reported (e.g. Kessler et al., 2005). The
numbers vary between 11% and 61% (e.g. Triffleman et al., 1995; Najavits et
al., 1997; Brown et al., 1995). The problems that these patients might have as
a result of PTSD, such as sleeping problems, anxiety and hyperaroussel, can
interfere with the treatment they receive, aimed at their substance abuse
problems. Seeking Safety is a therapy for trauma and addiction that was
developped in the US. It uses cognitive behavioral therapy, attention for the
interpersonal domain and case-management. Seeking Safety is a treatment that
showed good results so far within substance use dependent samples in the US.
Therefore it might be a good treatment in addition to standard addiction
treatment. We are expecting a significant improvement in substance use and
trauma related symptoms in the patientgroup that receives "Seeking Safety"
compared to the group that does not.
Study objective
To test the effectiveness of the psychotherapy "Seeking Safety" in a Dutch SUD
sample.
Study design
The study will be conducted within two populations: inpatient and outpatient.
For the inpatients, the study will follow a controlled design. Within one
facility, two locations will participate, where in one facility Seeking Safety
will be added to the standard treatment program and in the other treatment as
usual will be offered. For the outpatients the study will be a multi-centre
randomized controlled trial. Within each facility patients will be randomly
assigned to one out of two groups: one will receive treatment as usual, the
other will receive Seeking Safety in addition to treatment as usual.The overall
goal of the study is to test the effect of a new integrated therapy for trauma
and substance use disorder, Seeking Safety. Self-report questionnaires will be
used to measure improvement at three points: at the start of the treatment
(t=0), at completion of the treatment (or after 3 months, t=1) and 3 months
after completion of the treatment (follow-up, t=2).
Intervention
Control group will receive 'Treatment as usual' (TAU). De experimental group
will receive twice a week sessions of Seeking Safety (the intervention) in
addition to TAU. Each session lasts 75-90 minutes.
Study burden and risks
In this study, questionnaires will be administered on three different
appointments: at the start, at the finish and at follow-up. Most of the
questionnaires are self-report, thereby minimizing strain for the participant.
The questionnaires will gather information about different subjects:
trauma-related symptoms, coping strategies, depression and anxiety, substance
use, quality of life and patient satisfaction with treatment. One questionnaire
might trigger stress for patients because of the fact that the questionnaire
might trigger memories of t traumatic experiences that happened in the past.
However, none of the questionnaires asks specificaly for exact events in order
to keep psychological strain at a minimum. Researchers and clinicians are well
informed on how to handle situations in which patients react in a stressful
way. Participation with the study is completely voluntary.
Keulenstraat 3
Deventer 7418 ET
NL
Keulenstraat 3
Deventer 7418 ET
NL
Listed location countries
Age
Inclusion criteria
- Criterium A of PTSD and score >39 on SRIP
- Minimum age of 18
- Speaks and understands Dutch language
- DSM-IV diagnosis SUD
- Given informed consent
Exclusion criteria
- Severe psychiatric disorders (bipolar disorder, schizophrenia) that impede participation
- Severe (self) destructive behavior
- Insufficient level of intelligence (estimated IQ<85)
- Active PTSD treatment in the last six months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33469.044.11 |