This study is a randomized controlled trial comparing two treatments for patients with comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted within two different routine clinical settings for the treatment of SUD, namely (a) a day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take place separately for each setting. It is expected that the combined treatment is significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3 months, 6 months and 12 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.
Patients progress through three stages, in which instructions for writing and feedback by therapists are successively aimed at achieving trauma processing, cognitive restructuring and social sharing of a traumatic event.
JellinekMentrum
Amsterdam, Netherlands
Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
Time frame: Pre-treatment, Post-treatment; 3 months follow-up; 6 months; 12 months follow-up
PTSD symptom severity assessed with the Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
Time frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
DSM-IV diagnoses of SUD and PTSD assessed with the Structured Clinical Interview for the DSM-IV (SCID)
Time frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
Inventory of Drug Use Consequences (INDUC-2r)
Time frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)
Time frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)
Time frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Metacognitions concerning alcohol and/or drug-use assessed with the Positive Alcohol Metacognitions Scale (PAMS)
Time frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Difficulties in Emotion regulation (DERS)
Time frame: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up
Interpretation of PTSD-symptoms (PTSD-IPSI)
Time frame: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up
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