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

Substance-Related Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763542
• Other study ID #: 2008-KP-342
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2008
• Last updated: November 3, 2013
• Start date: July 2008
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Netherlands	JellinekMentrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Inventory of Drug Use Consequences (INDUC-2r)		Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up	No
Secondary	Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)		Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up	No
Secondary	Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)		Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up	No
Secondary	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	No
Secondary	Difficulties in Emotion regulation (DERS)		Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up	No
Secondary	Interpretation of PTSD-symptoms (PTSD-IPSI)		Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up	No