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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

Primary Purpose

Substance-Related Disorders, Stress Disorders, Post-Traumatic

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
CBT for SUD
Structured writing therapy for PTSD
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • JellinekMentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

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

CBT for SUD only

Outcomes

Primary Outcome Measures

Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
PTSD symptom severity assessed with the Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
DSM-IV diagnoses of SUD and PTSD assessed with the Structured Clinical Interview for the DSM-IV (SCID)

Secondary Outcome Measures

Inventory of Drug Use Consequences (INDUC-2r)
Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)
Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)
Metacognitions concerning alcohol and/or drug-use assessed with the Positive Alcohol Metacognitions Scale (PAMS)
Difficulties in Emotion regulation (DERS)
Interpretation of PTSD-symptoms (PTSD-IPSI)

Full Information

First Posted
September 30, 2008
Last Updated
November 3, 2013
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00763542
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Combined treatment: CBT for SUD plus structured writing therapy for PTSD
Arm Title
II
Arm Type
Active Comparator
Arm Description
CBT for SUD only
Intervention Type
Behavioral
Intervention Name(s)
CBT for SUD
Intervention Description
CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.
Intervention Type
Behavioral
Intervention Name(s)
Structured writing therapy for PTSD
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Inventory of Drug Use Consequences (INDUC-2r)
Time Frame
Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
Title
Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)
Time Frame
Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Title
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
Title
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
Title
Difficulties in Emotion regulation (DERS)
Time Frame
Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up
Title
Interpretation of PTSD-symptoms (PTSD-IPSI)
Time Frame
Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul MG Emmelkamp, Professor
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debora van Dam, MSc
Organizational Affiliation
University of Amsterdam
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ellen Vedel, PhD
Organizational Affiliation
JellinekMentrum
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Ehring, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
JellinekMentrum
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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