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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

NCT00763542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-11-05

No results posted yet for this study

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.

Conditions

  • Substance-Related Disorders
  • Stress Disorders, Post-Traumatic

Interventions

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.

BEHAVIORAL

CBT for SUD

CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.

Sponsors & Collaborators

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Paul MG Emmelkamp, Professor · University of Amsterdam

  • Debora van Dam, MSc · University of Amsterdam

  • Ellen Vedel, PhD · JellinekMentrum

  • Thomas Ehring, PhD · University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-07-31
Completion
2013-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00763542 on ClinicalTrials.gov