Screening and personality-aspects in post-traumatic stress disorder (PTSD) - substance use disorder patients

ISRCTN	ISRCTN42030125
DOI	https://doi.org/10.1186/ISRCTN42030125
Protocol serial number	NL24822.044.08
Sponsor	Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands)
Funders	This study is funded by the following four addiction centres:, Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands), IrisZorg (Netherlands), GGZ Noord en Midden Limburg (Netherlands), Novadic Kentron (Netherlands)

Submission date: 01/12/2008
Registration date: 27/02/2009
Last edited: 27/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Hein de Haan
Scientific

Keulenstraat 3
Deventer
7418 ET
Netherlands

Study information

Primary study design	Observational
Study design	Observational cross-sectional study
Secondary study design	Cross-section survey
Study type	Participant information sheet
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)
Study objectives	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(s)	Medical Ethical Testing Committee (METC) of Medisch Spectrum Twente, approved in November 2008 (ref: NL 24822.044.08).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key 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
Key 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.
Date of first enrolment	15/11/2008
Date of final enrolment	15/06/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Keulenstraat 3

Deventer
7418 ET
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes