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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Combined treatment: CBT for SUD plus structured writing therapy for PTSD |
|
| II | Active Comparator | CBT for SUD only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT for SUD | Behavioral | CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996) | 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) | 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) | Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Drug Use Consequences (INDUC-2r) | Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up | |
| Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI) | Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul MG Emmelkamp, Professor | University of Amsterdam | Principal Investigator |
| Debora van Dam, MSc | University of Amsterdam | Study Director |
| Ellen Vedel, PhD | JellinekMentrum | Study Chair |
| Thomas Ehring, PhD | University of Amsterdam | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JellinekMentrum | Amsterdam | Netherlands |
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| Structured writing therapy for PTSD | Behavioral | 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. |
|
| Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ) | 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) | Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up |
| Difficulties in Emotion regulation (DERS) | Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up |
| Interpretation of PTSD-symptoms (PTSD-IPSI) | Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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