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

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

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 Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: CBT for SUD; Behavioral: Structured writing therapy for PTSD

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • JellinekMentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I; Combined treatment: CBT for SUD plus structured writing therapy for PTSD	Behavioral: CBT for SUD; CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.; Behavioral: Structured 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.
Active Comparator: II; CBT for SUD only	Behavioral: CBT for SUD; CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Investigators: Study Chair: Thomas Ehring, PhD, University of Amsterdam; Study Director: Debora van Dam, MSc, University of Amsterdam; Study Chair: Ellen Vedel, PhD, JellinekMentrum

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 3, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Substance-Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2008-KP-342