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Efficacy of Rational Rehabilitation (RR) in the treatment of patients with a Posttraumatic stress-disorder (PTSD) lasting longer than half a year.


- candidate number3102
- NTR NumberNTR1244
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2008
- Secondary IDsNL13920.097.06. CCMO
- Public TitleEfficacy of Rational Rehabilitation (RR) in the treatment of patients with a Posttraumatic stress-disorder (PTSD) lasting longer than half a year.
- Scientific TitleEfficacy of Rational Rehabilitation (RR;a cognitive behaviour therapy) in the treatment of patients with a Posttraumatic stress-disorder (PTSD) lasting longer than half a year.
- ACRONYMEfficacy of Rational Rehabilitation (RR; a cognitive behaviour therapy) in the treatment of patients with a Posttraumatic stress-disorder lasting longer than half a year.
- hypothesisRational Rehabilitation (RR) is effective in the treatment of patients with Posttraumatic stress-disorder.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD), Rational rehabilitation
- Inclusion criteria1. Diagnosis of PTSD (measured by the Klinische Interview voor PTSS, KIP; Hovens, 1994).
2. Symptoms of PTSD persisting for more than half a year.
3. Already been treated by an evidence based effective psychological treatment for PTSD.
4. Age older than eighteen.
5. Having mastered the Dutch language.
6. Free to participate treatment.
7. Written agreement of participation on the research.
- Exclusion criteria1. Still being treated for PTSD.
2. Unfinished primary school.
3. Acute danger for the self or the surroundings/involuntary treatment.
4. Diagnosis of:
Mania, psychotic disorder, high suicide risk, drugs abuse (measured by the M.I.N.I. International Neuropsychological Interview, Nederlandse versie 5.0.0. ,M.I.N.I. plus; van Vliet, Leroy & Van Megen, 2000).
5. Neuropsychiatric disorder (measured by the Mini Mental State Examination; Folstein, Folstein & Mc Hugh,1975).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate30-dec-2012
- Target number of participants42
- InterventionsRR is a cognitive behaviour therapy, consisting of nine sessions at most and lasting about three months.
Patients are recruited by therapists working for Lentis and/or PsyQ. By means of a lottery they’re assigned to the experimental- or control-condition. Patients in the experimental condition are treated with RR immediately; patients in the control condition have to wait three months before starting RR.
- Primary outcomeSymptoms of PTSD
( Measured by: A: The Dutch version of the PTSD Symptom Scale-Self-Report, PSS-SR; Foa, Riggs, Dancu & Rothbaum,1993.)
- Secondary outcomeB: General psychic complaints ( Measured by: Korte Klachten Lijst, KKL; Lange, Schrieken, Van der Ven & Blankers,2000; Lange & Appelo, in voorbereiding).
C: Quality of life ( Measured by: Dutch version of the WHO-Quality of Life Scale ; De Vries & Van Heck,1996).
D: Autonomy and social optimism (Measured by: Positieve Uitkomsten Lijst, PUL; Appelo & Schouten,2003; Appelo,2005).
E: Need for further treatment measured after completing therapy by asking the patient whether he still wants therapy. If so: what kind of treatment does the patient want and for what kind of complaints.
F: Implicit and explicit associations (measured respectively by: a computer test, the Implicit Association Test, IAT, Greenwald, McGhee & Schwarz, 1998 and self report visual analogue scale from 0 till 10 about the same items as the IAT).
- TimepointsExperimental condition:
Measurement before RR
(T1) : A,B,C,D,F
Measurement directly after finishing RR
(T2) : A,B,C,D,E,F
Measurement six months after T2
(T3) : A,B,C,D,E,F

Control condition:
Measurement at the beginning of a waiting time of three months
(T0): A,B,C,D,F
Measurement at the end of the waiting time
(T1): A,B,C,D,F
Measurement directly after finishing RR
(T2): A,B,C,D,E,F
Measurement six months after T2
(T3): A,B,C,D,E,F
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.T. Tomasoa
- CONTACT for SCIENTIFIC QUERIESDr. M.T. Appelo
- Sponsor/Initiator Wetenschappelijk Onderzoek Lentis
- Funding
(Source(s) of Monetary or Material Support)
Lentis
- PublicationsTomasoa, A.T., & Appelo, M.T. (2007). Rationele Rehabilitatie bij Posttraumatische stress-stoornis. Een pilotonderzoek. Tijdschrift voor Psychiatrie, 49,529-536.
- Brief summaryIn this trial the efficacy of Rational Rehabilitation (RR) in the treatment of patients with a Posttraumatic stress- disorder (PTSD) lasting longer than half a year, is studied.
PTSD is a serious common illness, often lasting for many years. Especially chronic PTSD is still in need of effective therapies. RR is a cognitive behaviour therapy, consisting of nine sessions at most and lasting about three months.
Efficacy of RR is primarily expressed in terms of symptoms of PTSD and secondary in terms of general psychic complaints, quality of life, autonomy, social support and need for further treatment.
- Main changes (audit trail)
- RECORD11-mrt-2008 - 27-mei-2008


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