Objective: primary hypothesis: The level of complaints drops more in patients who have completed module schemafocused mindfulness than in patients who have completed the module self-image. Secondary hypotheses: The Personality Severity Index (PSI)…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main Parameter: The main parameter in this study is the score of the SCL-90.
The expectation is that patients with personality problems benefit more from
schemafocused mindfulness training group than in the module self-image training
group. The score on the SCL-90 would have to decrease more in the module
schemafocused mindfulness training group than in the module self-image group
training. This is considered to be a moderate effect: 0.25.
Secondary outcome
Secondary outcome measures:
scores on the YSQ, SMI I, MAAS and RSES.
The Personality Severity Index (PSI) (part of the SCL-90) during decreases more
during module schemafocused mindfulness than during module self-image.
The intensity of the schema modes and schemas decreasesmore during module
schemafocused mindfulness than during module self-image.
The degree of mindfulness increases stronger during module schemafocused
mindfulness than during module self-image.
The self-image enhances more during module self-image than during module
schemafocused mindfulness
Background summary
Rationale: It seems important to develop short treatment modules for
personality disorders that can be used in a stepped care model. In addition to
develop these modules is also important to investigate the effectiveness of
these modules. So far there haven't been done researches. This pilot study is
the first step of researching the effectiveness of schemafocused mindfulness
for patients with personality problems or personality disorders. Clinical
experience with this module has already been gained and the results appear
favorable for patients. This module will be compared with self-image module
that has already been researched with very beneficial effects. The main
hypothesis of this research proposal is that schemafocused mindfulness group
training has a broader and deeper effect on symptoms than the module self-image
group training, since the latter module is focused on the self-image based on
the doing-mode and the module schemafocused mindfulness learns patients to
adopt a different attitude towards complaints by the mindfulness aspect and
thus the being-mode allowing changes in self-image to come from acceptance and
not from changes orientation. Because this research is a pilot study, the
conclusions about the outcome must be interpreted with care.
Study objective
Objective: primary hypothesis:
The level of complaints drops more in patients who have completed module
schemafocused mindfulness than in patients who have completed the module
self-image.
Secondary hypotheses:
The Personality Severity Index (PSI) for the module schemafocused mindfulness
will drop more than during the module self-image.
The intensity of the schema modes and schemas decreases more during module
schemafocused mindfulness than during module self-image.
The degree of mindfulness increases stronger during module schemafocused
mindfulness than during module self-image.
The self-image enhances more during module self-image than during module
schemafocused mindfulness.
Study design
Study design: In this RCT there will be used a mixed design. We will look for
in and between group variables with an ANOVA with repeated measures. The
duration of the study covers three years. The module schemafocused mindfulness
group training and module self-image group training will be offered via GGZ
Delfland to patients with personality problems.
Intervention
Intervention: Patients are randomly attached to the module schemafocused
mindfulness training group or to the module self-image training group. Prior to
the module, patients will complete test material, namely SCL-90, SMI I, YSQ,
MAAS and RSES. After the group training, patients will re-fill test material. A
month after the modules have been completed, patients will re-fill again test
material.
Study burden and risks
The degree to which subjects are exposed to hazards, risks or burden: The risk
of SAE (serious adverse events) is small because the test material used, is
regular. During the diagnostic phase, patients may be confronted with their
sensitive strings. This will be discussed afterwards with the patient.
Reinier de Graafweg 7a
Delft 2625 AD
NL
Reinier de Graafweg 7a
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Patients need to have as primary diagnosis on axis II a personality disorder. Features of a personality disorder instead of a fullblown personality disorder will also be included.
Exclusion criteria
psychotic features, substance abuse, untreated ADHD, bipolar I disorder, IQ lower then 80 points.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37067.098.11 |