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Completed

NCT Number: NCT00763542

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

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

JellinekMentrum

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT for SUD

Behavioral

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Inventory of Drug Use Consequences (INDUC-2r)

    Time frame: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up

  2. Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)

    Time frame: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up

  3. 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

  4. 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

  5. Difficulties in Emotion regulation (DERS)

    Time frame: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up

  6. Interpretation of PTSD-symptoms (PTSD-IPSI)

    Time frame: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Oct 1, 2008
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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