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Ouderen met Gedragsmatige en Psychologische Symptomen van Dementie in de Geestelijke Gezondheidszorg


- candidate number26612
- NTR NumberNTR6665
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jan-2017
- Secondary IDs16-N-228  METC Zuyderland-Zuyd
- Public TitleOuderen met Gedragsmatige en Psychologische Symptomen van Dementie in de Geestelijke Gezondheidszorg
- Scientific TitleElderly with Behavioral and Psychological Symptoms of Dementia in Mental Healthcare Practices in the Netherlands: the Feasibility of Mediation Therapy based on Comorbid Maladaptive Personality Traits
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedOlder adults, Behavioral problems, Aged
- Inclusion criteriaBehavioral and psychological symptoms of dementia in combination with comorbid maladaptive personality traits in older patients.
- Exclusion criteriaBehavioral symptoms caused by delirium, current drug-related disorders, psychotic disorders, bipolar disorder, and behavioral symptoms without comorbid maladaptive personality traits
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate31-mei-2018
- Target number of participants54
- InterventionsFor all patients admitted between January 1, 2017 and May 31, 2018, the mental competence (for this study), will be assessed by the psychiatrist. In the case of mental competence, the patient will be given (written) information about current research. After the patient's informed consent, the first contact person will be approached to fill out three questionnaires to assess the (premorbid) personality of the patient. However, if the patient is mentally incompetent, the patient's representative will be asked for his/her permission for this study. If the patient (or the representative) wants to participate in this study the CMAI-D and NPI-Q will be filled out within 14 days after admission (by the First Responsible nurse) as a pre-measurement (T1) .

During the multidisciplinary consultation, the staff will formulate a diagnostic working hypothesis according to the DSM-5, core need(s), problem behavior, triggering event(s), consequences of the problem behavior, and the compensation for the triggering event. Based on this information, the staff will choose up to three nursing interventions which will be applied at least until the next multidisciplinary consultation. The effect of the intervention will be evaluated using the CMAI-D and NPI-Q. If the challenging behavior has not decreased, up to three new and/or previously tried interventions will be chosen again to apply until the next multidisciplinary consultation. This repeats until the challenging behavior does not occur, has decreased sufficiently or until the patient has been discharged.
- Primary outcomeChallenging behavior as assessed with the Cohen-Mansfield Agitation Inventory - Dutch (CMAI-D) and Neuropsychiatric Inventory - Questionnaire (NPI-Q)
- Secondary outcomeAnother main objective is to estimate important parameters needed to design a follow-up study, such as standard deviation of outcome measures, participant willingness to participate, follow-up ratios, response ratios on questionnaires, compliance, etc.
- TimepointsT1 is within 14 days after admission. Ten weeks after T1, a second measurement (T2) will take place. If a patient is discharged earlier than ten weeks, T2 follows within one week before discharge.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Erol Ekiz
- CONTACT for SCIENTIFIC QUERIES Erol Ekiz
- Sponsor/Initiator GGZ Breburg, Mondriaan GGZ
- Funding
(Source(s) of Monetary or Material Support)
GGZ Breburg, Mondriaan GGZ
- Publications
- Brief summaryBehavioral and Psychological Symptoms of Dementia (BPSD) are very common in geriatric psychiatry. BPSD can be experienced as challenging for patients, family and professional caregivers. There are indications that BPSD can be caused or maintained by comorbid maladaptive personality traits (CMPT). To date, cognitive-behavioral therapy, aimed at behavior change through the patient's environment (mediation therapy), has been studied extensively as a treatment for BPSD, with moderate effect sizes. However, no research has been conducted focusing specifically on mediation therapy in patients with BPSD and CMPT. Providing mediation therapy based at a cognitive behavioral model of personality disorders for BPSD (CGM) might improve quality of life, increase the sense of competence of the environment and decrease BPSD. CGM is based on a formulation that incorporates CMPT. The hypothesis of this study is that CGM, supplemented with nursing interventions from the Nursing Intervention Classification, is applicable to the treatment of challenging behavior in patients with BPSD and CMPT. To investigate this, elderly patients with BPSD and CMPT (from two Mental Healthcare clinics in the Netherlands) will receive mediation therapy according to CGM. The purpose of this study is to investigate the feasibility of CGM. We expect that patients treated with mediation therapy using CGM is associated with a significant decrease of BPSD.
- Main changes (audit trail)
- RECORD31-jan-2017 - 1-okt-2017


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