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Mentalization Based Treatment for Psychosis


- candidate number19324
- NTR NumberNTR4747
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2014
- Secondary IDs13-3-066.5/ab MEC AZM / MU
- Public TitleMentalization Based Treatment for Psychosis
- Scientific TitleMentalization Based Treatment for Psychosis: A randomized controlled trial for outpatients with a nonaffective psychotic disorder
- ACRONYMMBT-P
- hypothesisPatients who receive treatment as usual (TAU) plus mentalization-based treatment for psychosis (MBT-P) will show a greater improvement in social functioning than patients who receive TAU only. This effect is mediated by an increase of social cognition and a decrease of social stress reactivity.
- Healt Condition(s) or Problem(s) studiedNon affective psychosis , Schizoaffective disorder, Schizophrenia, Schizophreniform disorder
- Inclusion criteria- Age 18-55
- Informed consent
- Diagnosis of a nonaffective psychotic disorder
- In treatment for at least a year, but no longer than 5 years
- Exclusion criteria- Intellectual disabilities and/or illiteracy.
- A lack of mastery of the Dutch language.
- Severe addiction to such an extent that inpatient detoxification is necessary. After detoxification the patient is still eligible for participation in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-aug-2014
- planned closingdate31-jul-2018
- Target number of participants90
- Interventions-Mentalization Based Treatment for Psychosis
-Treatment as usual for NAPD: psychiatric consults, supportive therapy, wellfare aid, case management.
- Primary outcomeSocial Functioning (Social Functioning Scale: average score), Timepoints: 0 months, 9 months, 18 months, 24 months.
- Secondary outcome-Quality of Life (MANSA), Timepoints: 0 months, 18 months, 24 months.
-Psychotic Symptom Severity (PANSS / Psymate), Timepoints: 0 months, 9 months (Psymate only), 18 months, 24 months.
-Negative Affect (Psymate), Timepoints: 0 months, 9 months, 18 months, 24 months.
-Positive Affect (Psymate), Timepoints: 0 months, 9 months, 18 months, 24 months.
-Social Stress (Psymate), Timepoints: 0 months, 9 months, 18 months, 24 months.
-Social Cognition (Thematic Apperception Test), Timepoints: 0 months, 18 months, 24 months.
-Theory of Mind (Hinting Task), Timepoints: 0 months, 18 months, 24 months.
-Disease Awareness (Item G12 of the PANSS), Timepoints: 0 months, 18 months, 24 months.
-Substance abuse (Psymate), Timepoints: 0 months, 9 months, 18 months, 24 months.
- Timepoints0 months: baseline measurement
9 months: halfway treatment measurment
18 months: end of treatment measurement
24 months: follow-up measurement
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES J.G. Weijers
- CONTACT for SCIENTIFIC QUERIES J.G. Weijers
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Rivierduinen, Leiden
- Publicationsnone yet
- Brief summaryMany patients with nonaffective psychotic disorders (NAPD) suffer impairments in social cognition and an emotional hyperreactivity to social stress, which often lead to decreased social functioning.
Mentalization Based Treatment for Psychosis (MBT-P) is developed to target impaired social cognition. It is a psychodynamic treatment rooted in attachment and cognitive theory developed for the treatment of NAPD. It is expected to improve social cognition and decrease social stress reactivity which in turn are expected to improve social functioning. MBT-P is further expected to increase quality of life and disease awareness, and to reduce substance abuse, positive, anxious and depressive symptoms.
- Main changes (audit trail)Inclusion criteria:
Old:
- Age 18-55
- Informed consent
- Diagnosis of a nonaffective psychotic disorder
- In treatment for at least a year, but no longer than 5 years

New:
- Age 18-55
- Informed consent
- Diagnosis of a nonaffective psychotic disorder
- In treatment for at least a year, but no longer than 10 years
- RECORD19-aug-2014 - 3-nov-2016


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