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

Phase 2

Completed

• Conditions: Substance-Related Disorders; Stress Disorders, Post-Traumatic

• Registration Number: NCT00763542
• Lead Sponsor: VU University of Amsterdam

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2011-07
• Study Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-03
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Inventory of Drug Use Consequences (INDUC-2r)	Pre-treatment, Post-treatment, 3 months follow-up, 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
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
Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)	Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up

Trial Locations

Locations (1)

JellinekMentrum; 🇳🇱 Amsterdam, Netherlands