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A study on the effectiveness of the cognitive behavioral therapy "Seeking Safety" in reducing trauma and addiction related symptoms in a Dutch substance-use disorder population.


- candidate number10349
- NTR NumberNTR3084
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2011
- Secondary IDs33469 METC Twente
- Public TitleA study on the effectiveness of the cognitive behavioral therapy "Seeking Safety" in reducing trauma and addiction related symptoms in a Dutch substance-use disorder population.
- Scientific TitleA study on the effectiveness of the cognitive behavioral therapy "Seeking Safety" in reducing trauma and addiction related symptoms in a Dutch substance-use disorder population.
- ACRONYM
- hypothesisIntervention group will show more improvement on substance use and trauma-related symptoms than control group.
- Healt Condition(s) or Problem(s) studiedTrauma , Alcohol abuse, Posttraumatic stress symptoms, Substance abuse
- Inclusion criteria1. Patient is indicated for clinical, day time or outpatient treatment within Tactus Addiction Treatment during the research period;
2. Age 18 years or older;
3. Speaks and understands Dutch language;
4. Signed informed consent;
5. Criterium A of PTSD and a score of 29 on the SRIP.
- Exclusion criteria1. Severe psychiatric disorders that impede participation such as a severe bipolar or psychotic disorder;
2. Severe (self) destructive behavior;
3. Insufficient level of intelligence to participate in the study (estimated IQ below 85);
4. Active PTSD treatment within the last six months.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate31-dec-2013
- Target number of participants130
- InterventionsSeeking Safety. A cognitive behavioral therapy focused on integrated treatment of substance use and PTSD, through coping-skillstraining, psycho-education and learning to obtain safety in all areas of life. It consists of 25 sessions of 75 minutes which will be offered twice a week for a duration of three months. This treatment will be offered in addition to treatment as usual, which is cognitive behavioral based relapse prevention. This treatment consists of weekly sessions of 2 hours for three months. The control group will only receive TAU.
- Primary outcomeSeverity of substance use as measured with the EuropASI at the start of treatment, the end of treatment and follow-up after three months.
- Secondary outcomeTraumatic symptoms, as measured with the Self-report Inventory for PTSD at the start of treatment, the end of treatment and follow-up after three months.
- TimepointsStart of treatment, end of treatment (three months after start) and three months after end of treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Tim Kok
- CONTACT for SCIENTIFIC QUERIES Tim Kok
- Sponsor/Initiator Tactus Addiction Treatment
- Funding
(Source(s) of Monetary or Material Support)
Tactus Addiction Treatment
- PublicationsN/A
- Brief summaryA randomized controlled trial in outpatient substance use patients and a controlled trial in an inpatient SUD population, to test the efficacy of Seeking Safety in addition to TAU, compared to TAU. It is expected that the intervention group will improve more on substance use severity and trauma symptoms (as measured with the EuropASI and the SRIP) than the control group.
- Main changes (audit trail)
- RECORD15-sep-2011 - 18-okt-2011


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