Condition category
Mental and Behavioural Disorders
Date applied
01/12/2008
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hein de Haan

ORCID ID

Contact details

Keulenstraat 3
Deventer
7418 ET
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL24822.044.08

Study information

Scientific title

A study on the psychometric qualities of post-traumatic stress disorder (PTSD) screeners and the role of personality (measured by the NEO Five-Factor Inventory [NEO-FFI]) in patients with the comorbid diagnosis of PTSD and substance use disorder (SUD)

Acronym

Study hypothesis

1. What are the sensitivity and specificity of the Self Inventory List (Zelf inventarisatie lijst [ZIL]) and the post-traumatic stress disorder (PTSD) section of the Mini-International Neuropsychiatric Interview Plus (MINI-PLUS) as a screening instrument for PTSD in substance use disorder (SUD) patients?
2. What are the personality profiles for patients with the comorbid diagnosis of PTSD-SUD?

Ethics approval

Medical Ethical Testing Committee (METC) of Medisch Spectrum Twente, approved in November 2008 (ref: NL 24822.044.08).

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-traumatic stress disorder, substance use disorder

Intervention

This observational cross-sectional study examines whether patients in four addiction centres meet criteria for PTSD as well as criteria for SUD. Participants will be asked to complete the following assessments in two days:

Day 1:
1. Clinical Interview for PTSD (Klinische Interview voor PTSS [KIP])
2. ZIL
3. M.I.N.I. Plus (PTSD section)

Day 2:
4. Depression Anxiety Stress Scales (DASS)
5. Composite International Diagnostic Interview (CIDI) - Substance Abuse Module (CIDI-SAM)
6. Traumatic Experiences Questionnaire (Vragenlijst Belastende Ervaringen [VBE])
7. European Addiction Severity Index (EuropASI)
8. NEO Five-Factor Inventory (NEO-FFI)
9. Twenty-Item Toronto Alexithymia Scale (TAS-20)
10. Bermont-Vorst Alexithymia Questionnaire (BVAQ)
11. Pictorial Representation of Illness Measure (PRISM)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sensitivity and specificity of ZIL and MINI plus (PTSD section), with KIP as gold standard
2. Difference between the NEO FFI profiles of the group PTSD-SUD and the group SUD-PTSD

Secondary outcome measures

1. History of several kinds of trauma, severity and time-course are carefully traced by VBE. Comparison will be made between groups that differ in the order of onset of the comorbid disorders, with regard to various outcomes of VBE (nature of trauma, duration, severity, age at onset).
2. Psychometric qualities of DASS in detecting PTSD in relation to other instruments (KIP, ZIL, M.I.N.I.-plus)
3. Alexithymia, assessed by TAS-20 and BVAQ

Overall trial start date

15/11/2008

Overall trial end date

15/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who are at least 18 years old, both males and females
2. Patients of addiction treatment centres who are inpatient for at least 4 weeks
3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (with text revision) (DSM-IV-TR) criteria for Substance Use Disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Inadequate level of the Dutch language
2. Severe cognitive impairment or damage
3. Severe (self) destructive behaviour

If a practitioner declares the patient is incapable of participation, the patient will be excluded.

Recruitment start date

15/11/2008

Recruitment end date

15/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Keulenstraat 3
Deventer
7418 ET
Netherlands

Sponsor information

Organisation

Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands)

Sponsor details

Keulenstraat 3
Deventer
7418 ET
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://tactus.nl

Funders

Funder type

Hospital/treatment centre

Funder name

This study is funded by the following four addiction centres:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

IrisZorg (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GGZ Noord en Midden Limburg (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novadic Kentron (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes