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Motivatie Onderzoek.


- candidate number10016
- NTR NumberNTR2968
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jul-2011
- Secondary IDsNL28344.097.09 CCMO
- Public TitleMotivatie Onderzoek.
- Scientific TitleMotivation and Treatment Engagement Intervention Trial.
- ACRONYMMotivaTe-IT
- hypothesisWe want to study the effect of feedback to the clinician concerning the motivation of the patient to see if this feedback leads to a better motivation, compliance and treatment result because the clinician is more aware of the motivation (or the lack of motivation) of the patient and can take this into account in the treatment of the patient. Also we want to study what factors coincide with (changes in) the motivation for treatment. Our hypothesis is that our intervention, called Motivation Feedback, will lead to a better motivation, better compliance and better treatment results.
- Healt Condition(s) or Problem(s) studiedTreatment, Motivation, Compliance, Feedback
- Inclusion criteria1. The patient has a psychotic disorder or a personality disorder;
2. The patient is currently receiving individual outpatient care;
3. The patient is an adult (between 18 and 65 years old).
- Exclusion criteria1. The patient has an organic psychosyndrome;
2. The patient has insufficient command of the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mei-2011
- planned closingdate13-mei-2013
- Target number of participants350
- InterventionsMotivation feedback means that the clinician receives feedback concerning the motivation of the patient on several occasions. The clinician will provide oneself with feedback monthly during a session with the patient. The feedback begins in the first month after the baseline measurement and ends after 12 months. Two groups will be compared with each other. The first group will receive a treatment including motivation feedback en the second group will receive a treatment without motivation feedback.
- Primary outcome1. Motivation, as measured by the Treatment Entry Questionnaire (TEQ), the University of Rhode Island Change Assessment - Dutch version (URICA-D) and the Treatment Motivation Scale for forensic patients (TMS-f);
2. Compliance, as measured by the Service Engagement Scale (SES) and data from the patients´ medical record on the frequency of missed appointments and drop-out.
- Secondary outcome1. Psychosocial functioning, as measured by the Health of the Nations Outcome Scale (HoNOS);
2. Quality of life, as measured by the Manchester Short Assessment of Quality of Life (MANSA).
- TimepointsBaseline assessment (T0) and follow-up assessment after one year (T1). For the clinicians and patients in the Motivation Feedback arm, short monthly assessments will take place regarding the motivation of the patient.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Eline Jochems
- CONTACT for SCIENTIFIC QUERIES Eline Jochems
- Sponsor/Initiator GGZ
- Funding
(Source(s) of Monetary or Material Support)
GGZ West North Brabant
- PublicationsThe effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial. Jochems EC, van der Feltz-Cornelis CM, van Dam A, Duivenvoorden HJ, Mulder CL. Neuropsychiatr Dis Treat. 2015 Dec 11;11:3049-64. doi: 10.2147/NDT.S95190. eCollection 2015.
- Brief summaryBackground:
Currently there is a lot of unclarity about the way motivation influences the treatment of patients with severe mental illness, as well as what possibilities there are to positively influence the motivation. A better comprehension of the role of motivation is important because motivation problems coincide with dropout, a lack of compliance and thence a less favourable treatment result.

Objective of the study:
We want to study the effect of feedback to the clinician concerning the motivation of the patient to see if this feedback leads to a better motivation, compliance and treatment result because the clinician is more aware of the motivation (or the lack of motivation) of the patient and can take this into account in the treatment of the patient. Also we want to study what factors coincide with (changes in) the motivation for treatment.

Study design:
This study is a clustered randomised study that is meant to establish the influence of motivation feedback on the motivation and compliance.

Study population:
This study will be conducted with patients with psychotic disorders and personality disorders. These patients will be recruited from several treatment teams for severe mental illnesses.

Intervention:
Motivation feedback means that the clinician receives feedback concerning the motivation of the patient on several occasions. The clinician will provide oneself with feedback monthly during a session with the patient. The feedback by session begins in the first month after the baseline measurement and ends after 12 months. Two groups will be compared with each other. The first group will receive a treatment including motivation feedback en the second group will receive a treatment without motivation feedback.
- Main changes (audit trail)04-Jan-2013: Due to a peer review process, changes have been made to the protocol:
1. New enddate: 16-Sep-2013.
2. Primary outcome 'Motivation' will no longer be a primary outcome. Instead it will be a secondary outcome.
- RECORD5-jul-2011 - 22-jan-2017


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