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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00763542
First received: September 30, 2008
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Behavioral: CBT for SUD
Behavioral: Structured writing therapy for PTSD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996) [ Time Frame: Pre-treatment, Post-treatment; 3 months follow-up; 6 months; 12 months follow-up ] [ Designated as safety issue: No ]
  • PTSD symptom severity assessed with the Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997) [ Time Frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up ] [ Designated as safety issue: No ]
  • DSM-IV diagnoses of SUD and PTSD assessed with the Structured Clinical Interview for the DSM-IV (SCID) [ Time Frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory of Drug Use Consequences (INDUC-2r) [ Time Frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up ] [ Designated as safety issue: No ]
  • Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up ] [ Designated as safety issue: No ]
  • Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ) [ Time Frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up ] [ Designated as safety issue: No ]
  • Metacognitions concerning alcohol and/or drug-use assessed with the Positive Alcohol Metacognitions Scale (PAMS) [ Time Frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up ] [ Designated as safety issue: No ]
  • Difficulties in Emotion regulation (DERS) [ Time Frame: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up ] [ Designated as safety issue: No ]
  • Interpretation of PTSD-symptoms (PTSD-IPSI) [ Time Frame: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: July 2008
Study Completion Date: May 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763542

Locations
Netherlands
JellinekMentrum
Amsterdam, Netherlands
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam, The Netherlands
Study Director: Debora van Dam, MSc University of Amsterdam, The Netherlands
Study Chair: Ellen Vedel, PhD JellinekMentrum
Study Chair: Thomas Ehring, PhD University of Amsterdam, The Netherlands
  More Information

No publications provided

Responsible Party: Paul M.G.Emmelkamp, Proffesor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT00763542     History of Changes
Other Study ID Numbers: 2008-KP-342
Study First Received: September 30, 2008
Last Updated: November 3, 2013
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014