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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

NCT ID: NCT00763542

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Substance-Related Disorders Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

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

Group Type EXPERIMENTAL

CBT for SUD

Intervention Type BEHAVIORAL

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

Structured writing therapy for PTSD

Intervention Type 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.

II

CBT for SUD only

Group Type ACTIVE_COMPARATOR

CBT for SUD

Intervention Type BEHAVIORAL

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

Interventions

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CBT for SUD

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role lead

Responsible Party

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Paul M.G.Emmelkamp

Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul MG Emmelkamp, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Debora van Dam, MSc

Role: STUDY_DIRECTOR

University of Amsterdam

Ellen Vedel, PhD

Role: STUDY_CHAIR

JellinekMentrum

Thomas Ehring, PhD

Role: STUDY_CHAIR

University of Amsterdam

Locations

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JellinekMentrum

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2008-KP-342

Identifier Type: -

Identifier Source: org_study_id