Clinical trial NCT00763542: Combined Treatment for Patients With Comorbid Substance Use Disorders and Post-traumatic Stress Disorder (PTSD): an Integration of Cognitive-behavioral Treatment (CBT) and Trauma-focused Structured Writing Therapy
Official title: A Randomized Controlled Trial Comparing (1) a Combined Treatment of CBT for Substance Use Disorders (SUD) and Trauma-focused Structured Writing Therapy With (2) CBT for SUD Alone in Patients With Comorbid SUD and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Stress Disorders, Post-Traumatic
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
timeFrame: Pre-treatment, Post-treatment; 3 months follow-up; 6 months; 12 months follow-up
measure: PTSD symptom severity assessed with the Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
timeFrame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
measure: DSM-IV diagnoses of SUD and PTSD assessed with the Structured Clinical Interview for the DSM-IV (SCID)
timeFrame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
Secondary outcomes:
measure: Inventory of Drug Use Consequences (INDUC-2r)
timeFrame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
measure: Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)
timeFrame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
measure: Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)
timeFrame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
measure: Metacognitions concerning alcohol and/or drug-use assessed with the Positive Alcohol Metacognitions Scale (PAMS)
timeFrame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
measure: Difficulties in Emotion regulation (DERS)
timeFrame: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up
measure: Interpretation of PTSD-symptoms (PTSD-IPSI)
timeFrame: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: JellinekMentrum
Study officials:
affiliation: University of Amsterdam
name: Paul MG Emmelkamp, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Debora van Dam, MSc
role: STUDY_DIRECTOR
affiliation: JellinekMentrum
name: Ellen Vedel, PhD
role: STUDY_CHAIR
affiliation: University of Amsterdam
name: Thomas Ehring, PhD
role: STUDY_CHAIR
References: