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Treatment adherence therapy in non-adherent patients with psychotic disorders; a randomised trial.


- candidate number2933
- NTR NumberNTR1159
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-dec-2007
- Secondary IDs100-002  projectnumber of the financer: ZonMw
- Public TitleTreatment adherence therapy in non-adherent patients with psychotic disorders; a randomised trial.
- Scientific TitleTreatment adherence therapy in non-adherent patients with psychotic disorders; a randomised trial.
- ACRONYMTAT
- hypothesisTreatment Adherence Therapy + Treatment as Usual (TAT+TAU), as compared to TAU-only, has a beneficial effect on treatment adherence, as defined by no-show contacts, the degree of collaboration in managing the illness, help seeking behaviour in crisis situations, and medication compliance.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Psychosis
- Inclusion criteria1. A diagnosis of schizophrenia or related psychotic disorder;
2. non-adherence to treatment as defined by no-show contacts;
3. the degree of collaboration in managing the illness;
4. help seeking behaviour in crisis situations;
5. and medication compliance.
- Exclusion criteria1. Not speaking the Dutch language;
2. being admitted in a hospital;
3. court-ordered involuntary treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2005
- planned closingdate1-sep-2010
- Target number of participants120
- InterventionsThe Treatment Adherence Therapy (TAT) protocol is an intervention consisting of about ten sessions in which one or a combination of the three available modules get applied during about six months. Each module targets a specific cause for non-adherence in patients with schizophrenia. In the two arms of the study, TAT + Treatment as Usual (TAU) gets compared with TAU-only.
- Primary outcomeTreatment adherence, as defined by no-show contacts, the degree of collaboration in managing the illness, help seeking behaviour in crisis situations, and medication compliance.
- Secondary outcome1. Symptoms;
2. quality of life;
3. insight into illness;
4. relapse;
5. and readmission.
- TimepointsT0 at baseline, T1 directly after completion of the intervention, T2 at six month follow-up. Each of the outcome measures mentioned above are assessed at all three timepoints.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.B.P. Staring
- CONTACT for SCIENTIFIC QUERIESProf. Dr C.L. Mulder
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsStaring ABP, Mulder CL, van der Gaag M, Selten JP, Loonen AJM & Hengeveld MW (2006). Understanding and improving treatment adherence in patients with psychotic disorders; a review and a proposed intervention. Current Psychiatry Reviews, 2(4), p487-494.
- Brief summaryNon-adherence to treatment of patients with psychotic disorders is related to higher rates of relapse, hospitalization, and suicide. Attempts to improve adherence have shown that psychoeducation alone is not fully effective, and that motivational interviewing, behavioral strategies, and linking a patient’s personal goals to treatment may increase adherence. Based on the empirical data reviewed, we formed three clusters of possible causes of non-adherence, each of which can be targeted by a specific module of our developed Treatment Adherence Therapy (TAT). These three modules are: motivational interviewing, medication dosage trials, and behavioral training.
- Main changes (audit trail)
- RECORD7-dec-2007 - 9-apr-2008


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