|- candidate number||27805|
|- NTR Number||NTR6668|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-aug-2017|
|- Secondary IDs||NL58284.101.16 |
|- Public Title||How does clients' empathy and mental flexibility relate to treatment outcome? |
A longitudinal study of group psychotherapy and group cohesion in personality disorders.
|- Scientific Title||A longitudinal study of group psychotherapy and group cohesion in personality disorders|
|- hypothesis||The main objective is to assess the association of group cohesion, empathy, mental flexibility and treatment outcome in group psychotherapy for clients with personality disorders. It is expected that the level of client’s empathy and mental flexibility is a predictor of the level of treatment outcome and that this effect is partly explained by the mediator group cohesion. It is expected that the level of client’s empathy and mental flexibility increases over time of treatment and this effect is partly explained by the mediator group cohesion.|
|- Healt Condition(s) or Problem(s) studied||Personality disorder, Empathy, Group psychotherapy, Group cohesion|
|- Inclusion criteria||The participants will have been signed up and indicated by their therapists for group psychotherapy for personality disorders. |
|- Exclusion criteria||Because the participants will already have been indicated for group psychotherapy, the contra-indications of the institution will be used: an IQ below 80, presence of a psychotic disorder, severe axis I clinical diagnosis, paranoid personality disorder, lack of motivation, severe lack of self-reflection or no fixed abode.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jan-2019|
|- Target number of participants||80|
|- Interventions||Since the study has an observational design, no interventions are done. |
|- Primary outcome||Mental flexibility, which will be computed by the aggregated scores of Perseverative errors on the Wisconsin Card Sorting Test (WCST) and Percentile score on the TMT (by comparing the score on part B and part A while corrected for level of education and age). |
Empathy will be computed by the scores on the domains Perspective taking and Empathic concern of the Individual Reactivity Index.
Group cohesion will be computed by the total score on the Group Cohesion Questionnaire (GCQ-23).
Verbal intelligence will be computed by the IQ-score on the Nederlandse Leestest voor Volwassenen.
The secondary outcome measure will be defined as scores on the following questionnaires: the total score on the Symptom Checklist (SCL-90), the total score on the Outcome Questionnaire (OQ-45) and the total score on the World Organization Quality of Life Questionnaire (WHOQOL-Bref).
|- Secondary outcome||Post hoc comparisons will be done with the Time score on part B of the Trail Making Test (TMT), the scores on the four domains of the GCQ-23 and the score on the five domains of the SIPP-SF. Sex, age, level of education level, experience with group psychotherapy, current treatment orientation, current treatment group, number of groupmembers and kind of medication use. |
|- Timepoints||There will be four different test moments for this research. The first and last one will be six months apart. |
|- Trial web site||Not applicable|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Albert Matil|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Albert Matil|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||With this study we aim to research the association between client’s factors and treatment outcome of group psychotherapy for clients with personality disorders in order to aid in (contra-)indication and allocation of clients for types of treatment. The central question that the research is intended to answer is “How is treatment outcome associated with group cohesion, client’s empathy and client’s mental flexibility?” |
|- Main changes (audit trail)|
|- RECORD||30-aug-2017 - 10-sep-2017|