Abstract
BackgroundTraumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population.Methods/DesignA randomized controlled trial (RCT) will be used to test the efficacy of Seeking Safety compared to Cognitive Behavioral Therapy (CBT) in a population of SUD outpatients. Each treatment will consist of 12 group sessions. The primary outcome measure will be substance use severity. Secondary outcome measures are PTSD and trauma symptoms, coping skills, functioning, and cognitions. Questionnaires will be administered at the start of treatment, at the end of treatment (three months after the start of treatment) and at follow-up (six months after the start of treatment).DiscussionThis study protocol presents a RCT in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to CBT. It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up. Furthermore, a lower drop-out rate is expected for the intervention group. If the intervention proves to be effective, it can be implemented. A cost-effectiveness analysis will be conducted to evaluate the two treatments.Trial registrationThe protocol for this study is registered with the Netherlands Trial Register with number NTR3084 and approved by the local medical ethical committee (METC\\11270.haa).
Highlights
Traumatic experiences and, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients
This study protocol presents a randomized controlled trial (RCT) in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to Cognitive Behavioral Therapy (CBT)
It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up
Summary
There may be instances where a patient is included in the study while his symptoms are primarily related to substance use, but we still expect this patients to benefit from Seeking Safety in alleviating his symptoms The aim of this RCT is to test the efficacy of Seeking Safety versus CBT in an outpatient population of SUD patients. If the intervention group is more successful in reducing substance use and PTSD symptoms, it can be argued that Seeking Safety should be offered for patients presenting with trauma issues. The results showed that the intervention modestly improved clinical outcomes, especially drug use and trauma outcomes, and that there were no differences in cost between the intervention and the comparison condition This provides support for the notion that integrated and traumafocused interventions can be effective treatments for SUD patients with traumatic experiences, with no significant extra cost.
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