|- candidate number||17000|
|- NTR Number||NTR4472|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2014|
|- Secondary IDs||NL46081.018.13 NWO|
|- Public Title||SOS-training: an intervention to reduce the risk of victimisation in addicted patients with chronic psychiatric disorders.|
|- Scientific Title||SOS-training, Social skills and Street skills: An intervention to reduce the risk of victimisation: a randomised controlled trial in patients with substance use disorders and chronic psychiatric disorders|
|- hypothesis||Substance use disorders and chronic psychiatric disorders often occur together. This vulnerable group of dually diagnosed patients has a higher risk of being victimised. Up until now there is only limited evidence of interventions proven to be effective for this target group. This research is aimed to develop and investigate an intervention to reduce
vulnerability, to improve social skills and assertiveness and therefore reduce the risk of being victimised.
The main hypothesis of this research is:
Social skills and Street skills (SOS-training) is an intervention that reduces the risk of being victimised. The intervention group will show a lower frequency of victimisation in the 12 months after following the training, compared to the control group.|
|- Healt Condition(s) or Problem(s) studied||Victimization, Psychiatric disorders, Schizophrenia, Dual diagnosis, Addiction, Abuse, Violence|
|- Inclusion criteria||- In treatment for substance use disorder(s) and chronic psychiatric disorder(s)
- Capable of giving informed consent and participating in the training
|- Exclusion criteria||- Acute psychosis, which could interfere with participating in the training
- Severe anti-social personality disorder, which could disturb the group training
- High level of psychopathic traits, which could disturb the group training
- Legally incapable|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-jun-2017|
|- Target number of participants||200|
|- Interventions||Intervention: SOS-training (Social skills and street skills). A twelve-session group-based intervention.
Control intervention: Treatment as usual.|
|- Primary outcome||Victimisation, measured with the Safety Monitos (Veiligheidsmonitor). Timepoint: 14 months after baseline.|
|- Secondary outcome||Victimisation, measured with the Safety Monitor (Veiligheidsmonitor). Timepoint: 8 months.
Alcoholuse and druguse, measured with the Timeline Followback (TLFB). Timepoint: 2 months, 8 months, 14 months.
Severity of substance use disorders, measured with the Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT). Timepoints: 2 months, 8 months, 14 months.
Psychopathology, measured with the Brief Psychiatric Rating Scale (BPRS). Timepoint: 14 months.
Psychological distress, measured with the Kessler Psychological distress scale (K10). Timepoints: 2 months, 8 months, 14 months.
Post-traumatic Stress Disorder symptoms, measured with the Posttraumatic Diagnostic Scale (PDS). Timepoint: 14 months.
Emotion dysregulation, measured with the Difficulties in Emotion Regulation Scale (DERS). Timepoints: 2 months, 8 months, 14 months.
Social skills/interpersonal functioning, measured with the Inventory of Interpersonal Problems (IIP-32). Timepoints: 2 months, 8 months, 14 months.
Social functioning, measured with the Personal and Social Performance scale (PSP). Timepoints: 2 months, 14 months.
Agressive and social behaviour, measured with the Observation Scale for Agressive Behaviour (OSAB). Timepoints: 2 months, 14 months.
Anger management, measured with the Dimesions of Anger Reactions (DAR). Timepoints: 2 months, 8 months, 14 months.
Self-esteem, measured with the Self Esteem Rating Scale (SERS-SF 20). Timepoints: 2 months, 8 months, 14 months.
Quality of life, measured with the Manchester short assessment of quality of life (MANSA) and the EuroQol (EQ5D). Timepoints: 2 months, 8 months, 14 months.
Cost-effectiveness, measured with the Trimbos/iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P) and the EuroQol (EQ5D). Timepoints: 14 months.
All-cause mortality. Timepoint: 14 months.
Total days of hospitalisation. Timepoints: 14 months.|
|- Timepoints||Baseline, 2 months, 8 months, 14 months.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M. Waal, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A. Goudriaan|
|- Sponsor/Initiator ||Arkin Institute for Mental Health|
(Source(s) of Monetary or Material Support)
|- Brief summary||Patients with substance use disorders and chronic psychiatric disorders have a higher risk of being victimised. This research aims to investigate a novel intervention to reduce the risk of victimisation in this target group.|
|- Main changes (audit trail)||12-sep-2014: "Timepoints primary and secondary outcome don't apply anymore.|
Addition of the following secondary outcomes:
- Cognitive impairment (MMSE), baseline
- Perpetration (questions added to Safety Monitor)
- Perception of the likelihood of being victimized (questions added to Safety Monitor)
- Perceived Control (questions added to Safety Monitor)
- GAF-score" - AB
|- RECORD||24-mrt-2014 - 12-sep-2014|