Substance-Related DisordersPhase 2NCT00763542

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

A Phase 2 study testing CBT for SUD and Structured writing therapy for PTSD in people with Substance-Related Disorders and Stress Disorders, Post-Traumatic, run by VU University of Amsterdam at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Substance-Related Disorders, Stress Disorders, Post-Traumatic
What is being tested?: CBT for SUD and Structured writing therapy for PTSD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteNetherlands
Study dates: Jul 2008to May 2013
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

JellinekMentrum
Amsterdam

Other trials in Netherlands

About this study

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

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.

Conditions: Substance-Related Disorders, Stress Disorders, Post-Traumatic
Being tested: CBT for SUD, Structured writing therapy for PTSD
Medical subject headings: Substance-Related Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT for SUDBehavioural
CBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.
Structured writing therapy for PTSDBehavioural
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.

Study groups in NCT00763542
Study group	Role	What they receive
I	Experimental	Combined treatment: CBT for SUD plus structured writing therapy for PTSD Receives: Behavioral: CBT for SUD; Behavioral: Structured writing therapy for PTSD
II	Active comparator	CBT for SUD only Receives: Behavioral: CBT for SUD

What is being measured

The primary outcome is the main question the study is designed to answer.

Substance use assessed with the Time-Line Follow-Back Interview (TLFB; Sobell & Sobell, 1996)
Measured: 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)
Measured: 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)
Measured: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up

Secondary outcomes (6)

Inventory of Drug Use Consequences (INDUC-2r)
Measured: Pre-treatment, Post-treatment, 3 months follow-up, 6 months; 12 months follow-up
Trauma-related appraisals assessed with the Posttraumatic Cognitions Inventory (PTCI)
Measured: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Response to intrusions assessed with the Response to Intrusions Questionnaire (RIQ)
Measured: 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)
Measured: Pre-treatment, Post-treatment, 3 months, 6 months, 12 months follow-up
Difficulties in Emotion regulation (DERS)
Measured: Pre-treatment, Post-treatment, 3-months, 6 months; 12 months follow-up
Interpretation of PTSD-symptoms (PTSD-IPSI)
Measured: Pre-treatment, Post-treatment, 3 months; 6 months, 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008May 2013

First posted1 Oct 2008 (estimated)
Study startJul 2008
Primary completionJul 2011
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763542
Sponsor's protocol ID: 2008-KP-342
Status last verified: Nov 2013
First submitted: 30 Sep 2008
Last updated: 5 Nov 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00763542
Acronym / sponsor ID: 2008-KP-342
Conditions: Substance-Related Disorders, Stress Disorders, Post-Traumatic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: VU University of AmsterdamUniversity, hospital or other
Study start: Jul 2008
Primary completion: Jul 2011 (actual)
Study completion: May 2013 (actual)
First posted: 1 Oct 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
I	Experimental	Behavioral: CBT for SUD, Behavioral: Structured writing therapy for PTSDCombined treatment: CBT for SUD plus structured writing therapy for PTSD
II	Active comparator	Behavioral: CBT for SUDCBT for SUD only

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBT for SUDCBT for SUD focuses on patient-motivation, self-control strategies and relapse-prevention.	Behavioural	I, II
Structured writing therapy for PTSDPatients 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.	Behavioural	I

Primary outcome

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
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
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

6 secondary outcomes

Inventory of Drug Use Consequences (INDUC-2r)
Time frame: 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
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
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
Difficulties in Emotion regulation (DERS)
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.

Related trials for Substance-Related Disorders

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul MG Emmelkamp, Professor principal investigator

University of Amsterdam

Debora van Dam, MSc study director

University of Amsterdam

Ellen Vedel, PhD study chair

JellinekMentrum

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763542.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.