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 | Completed Phase 2

• 1 other identifier: 2008-KP-342
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

I

EXPERIMENTAL

Combined treatment: CBT for SUD plus structured writing therapy for PTSD

Behavioral: CBT for SUD; Behavioral: Structured writing therapy for PTSD

II

ACTIVE COMPARATOR

CBT for SUD only

Behavioral: CBT for SUD

Interventions

CBT for SUD BEHAVIORAL

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

I; II

Structured writing therapy for PTSD BEHAVIORAL

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.

I

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older
• Sufficient fluency in Dutch or English to complete treatment and research procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

JellinekMentrum

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Paul MG Emmelkamp, Professor

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Debora van Dam, MSc

  University of Amsterdam

  STUDY DIRECTOR

• Ellen Vedel, PhD

  JellinekMentrum

  STUDY CHAIR

• Thomas Ehring, PhD

  University of Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: May 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

NL (1)