Stress Disorders, Post-Traumatic, Substance-Related Disorders
Conditions
Brief summary
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.
Interventions
BEHAVIORALCBT for SUD
CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.
BEHAVIORALStructured writing therapy for PTSD
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.
Sponsors
VU University of Amsterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of substance abuse or substance dependence according to DSM-IV * Diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (at least one re-experiencing symptom plus either three avoidance/numbing or two hyperarousal symptoms are present) * 18 years or older * Sufficient fluency in Dutch or English to complete treatment and research procedures
Exclusion criteria
* Severe psychiatric problems that may interfere with study participation or that require more intensive clinical care than can be offered in the present study (e.g., dementia, psychotic symptoms, depression with suicidal ideation, manic episode and borderline personality disorder) * Receiving concurrent psychotherapy * Participants using tranquilizers are required to terminate medication use before inclusion * Participants using anti-depressant medication are required to stabilize medication use before inclusion.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Inventory of Drug Use Consequences (INDUC-2r) | Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up |
| Interpretation of PTSD-symptoms (PTSD-IPSI) | 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 |
| Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI) | Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up |
| Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ) | Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up |
Countries
Netherlands
Outcome results
None listed