Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763542
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • Inventory of Drug Use Consequences (INDUC-2r) [ Time Frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up ]
  • Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up ]
  • 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 ]
  • 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 ]
  • Difficulties in Emotion regulation (DERS) [ Time Frame: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up ]
  • Interpretation of PTSD-symptoms (PTSD-IPSI) [ Time Frame: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance-Related Disorders
  • Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: I
    Combined treatment: CBT for SUD plus structured writing therapy for PTSD
    Interventions:
    • Behavioral: CBT for SUD
    • Behavioral: Structured writing therapy for PTSD
  • Active Comparator: II
    CBT for SUD only
    Intervention: Behavioral: CBT for SUD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2013)
130
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
90
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763542
Other Study ID Numbers  ICMJE 2008-KP-342
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul M.G.Emmelkamp, VU University of Amsterdam
Study Sponsor  ICMJE VU University of Amsterdam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam
Study Director: Debora van Dam, MSc University of Amsterdam
Study Chair: Ellen Vedel, PhD JellinekMentrum
Study Chair: Thomas Ehring, PhD University of Amsterdam
PRS Account VU University of Amsterdam
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP