Screening and personality-aspects in post-traumatic stress disorder (PTSD) - substance use disorder patients
| ISRCTN | ISRCTN42030125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42030125 |
| Secondary identifying numbers | NL24822.044.08 |
- 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
Scientific
Keulenstraat 3
Deventer
7418 ET
Netherlands
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 15/11/2008 |
| Completion date | 15/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
7418 ET
Netherlands
Sponsor information
Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Keulenstraat 3
Deventer
7418 ET
Netherlands
| Website | http://tactus.nl |
|---|---|
"ROR" |
https://ror.org/00v0vvh64 |
Funders
Funder type
Hospital/treatment centre
This study is funded by the following four addiction centres:
No information available
Tactus Addiction Care Centre (Tactus Verslavingszorg) (Netherlands)
No information available
IrisZorg (Netherlands)
No information available
GGZ Noord en Midden Limburg (Netherlands)
No information available
Novadic Kentron (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
