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

November 3, 2013 updated by: Paul M.G.Emmelkamp, VU University of Amsterdam

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Inventory of Drug Use Consequences (INDUC-2r)
Time Frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
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
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
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
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
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
Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VU University of Amsterdam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Thomas Ehring, PhD, University of Amsterdam
  • Study Director: Debora van Dam, MSc, University of Amsterdam
  • Study Chair: Ellen Vedel, PhD, JellinekMentrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-KP-342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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