The following hypotheses are tested in the current study: 1) Metacognitive training is more effective than the standard treatment (TAU) for changing paranoid thinking in patients with psychotic disorders. Subhypothesis: 1a) Metacognitive training is…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes: The GPTS was chosen as primary outcome. The GPTS is a
questionnaire that measures paranoid ideas and ideas of social reference with
32 items on a 5-point Likert-scale. The internal consistency is good, with a
Crohnbach alpha > 0.70 and the test is consider valid.
Secondary outcome
Secondary outcomes: The EQ-5D is a standardized measure of health status
developed by the EuroQoL Group in order to provide a simple, generic measure of
health for clinical and economic appraisal. Applicable to a wide range of
health conditions and treatments, it provides a simple descriptive profile and
a single index value for health status that can be used in the clinical and
economic evaluation of health care as well as in population health surveys
[25]. The Davos Assessment of Cognitive Bias Scale (DACOBS) [26] is a
questionnaire thath measures the subjective experience of cognitive bias using
42 items on a 7-point Likert-scale. The following cognitive biases are
measured: the jumping-to-conclusions bias, dogmatism bias, slective attention
bias and the self-as-target bias. In addition, there are questions regarding
cognitive limitations and safety behaviors. The psychometric qualities of this
questionnaire are currently being investigated. The Beck Cognitive Insight
Scale (BCIS) [18] is a 15-item self-report scale measuring 2 constructs: the
ability to acknowledge fallibility, labeled self-reflectiveness and certainty
about belief and judgments, labeled self-certainty. A composite score
reflecting cognitive insight is calculated by subtracting the self-certainty
scale from the self-reflectiveness scale. The BCIS has demonstrated good
convergent, discriminant, and construct validity with inpatients. The PSYRATS
DRS [23] is a semi-structured interview whichs measures qualitative and
quantitative aspects of delusions. The Metacognitions Questionnaire 30 (MCQ30)
[27] is a questionnaire that measures metacognitions via 30 items on a 4-point
Likert-scale. The manual distinguishes between cognitive self-confidence,
positive views, cognitive self-awareness, uncontrollability and danger and
need-for-control. The Beads Task [28] is used to measure the tendency to jump
to conclusions. In the beads task, participants are shown two jars of coloured
beads, informed of the relative proportions of beads in each, then told that
they will be shown a series of beads drawn from one of the jars. They are then
asked, on the basis of the observed sequence, to judge which jar is the source
of the beads, and to be *as certain as possible*, but it is never possible to
be completely certain as to which jar the beads have been drawn from. The
Hinting Task [29] measures wether the participants have an understanding of the
real meaning behind indirect language use. The task consists of ten short
stories about interactions between two people. If the participant makes an
error, a hint is given. If another error is made, another hint is given. The
Beck Depression Inventory(BDI) [30] is a series of questions developed to
measure the intensity, severity and depth of depression in patients with
psychiatric diagnoses. Its long form is composed of 21 questions, each designed
to assess a specific symptom common among people with depression. In the Memory
Task [31] participants get time to look at a picture and are then asked to
recall as many details about it as possible. They are also asked to estimate
the degree of certainty they have about the recalls.
Background summary
In the Netherlands, the yearly incidence of schizophrenia and schizophrenic
psychoses is approximately 1 per 10,000 inhabitants. The prevalence has been
estimated to be 60 per 10,000 inhabitants. In many cases, the course of
schizophrenia is unfavourable and relapse is a common problem. In particular,
hallucinations and delusions are more common than has previously been thought.
The current study focuses on patients with clinically relevant delusions.
State-of-the-art treatment of psychoses and delusions consists of antipsychotic
medication prescribed by a psychiatrist, with or without therapist-administered
cognitive-behavioral therapy (CBT). The multidisciplinary guidelines for the
treatment of schizophrenia states that, *cognitive behavioural therapy is
indicated for patients with persistent positive symptoms*.Such therapy should
also be considered for patients with limited insight into their condition, or
with a lack of faith in medication.* CBT is known to have a small to medium
effect-size and it does not influence the chance of relapse.
In CBT, delusions are examined and challenged in order to bring about a
reduction of symptoms and to improve interpersonal relationships. Behavioral
experiments are also directed toward testing concepts and towards the
adaptation of beliefs based on the outcome of behavioral experimentation. This
is the case for all DSM Axis I disorders. However, a delusion is not simply an
incorrect interpretation such as occurs with anxiety and mood disorders.
Psychosis also involves cognitive deficits. These deficits are associated with
negative symptoms and limitations in the ability to fulfill social roles such
as student, parent, or employee. On the other hand, cognitive biases are
associated with positive symptoms such as delusions and hallucinations and play
a role in the development and persistence of delusions and hallucinations.
Recent theories related to the development and persistence of psychoses refer
to both the content of delusional thoughts and the cognitive biases as
fundamental to psychopathology. Experimental studies have shown that patients
who suffer from schizophrenia, in particular those with positive symptoms, have
several cognitive biases. Examples include the tendency to
jump-to-conclusions, source monitoring, a tendency to place too much faith in
false memories, problems with mentalization and the *bias against
disconfirmatory information*. The associations between cognitive biases and
psychotic symptoms have been demonstrated in experimental research. Recently,
Moritz and Woodward developed the Metacognitive training (MCT) that will be
tested in this study. The purpose of MCT is two-fold: 1) to educate the patient
about these cognitive biases and 2) to highlight the negative consequences of
these cognitive biases. So this study translates theoretical findings into
clinical practice. Only one feasability study has been published about this
training. That study demonstrated that patients enjoy the training and that
there were no drop-outs. A pilot study has been completed by us in eight mental
health institutions in the Netherlands. This pilot with 34 patients in an open
trial confirmed the low drop-out and enjoyment of the training. The results
were modest and showed only tendencies because of the low power. The module
'changing opinions*, significantly improved flexibility of thinking immediately
after the training-module. The study in this proposal will investigate the
efficacy and cost-effectiveness of MCT. The training is culture-free. Both men
and woman in the age range of 18-65 will be included in this study.
Study objective
The following hypotheses are tested in the current study: 1) Metacognitive
training is more effective than the standard treatment (TAU) for changing
paranoid thinking in patients with psychotic disorders.
Subhypothesis: 1a) Metacognitive training is more effective than the standard
treatment (TAU) for changing attributional style in patients with psychotic
disorders. 1b) Metacognitive training is more effective than the standard
treatment (TAU) for changing the jumping-to-conclusion-bias in patients with
psychotic disorders. 1c) Metacognitive training is more effective than the
standard treatment (TAU) for changing memory-bias in patients with psychotic
disorders. 1d) Metacognitive training is more effective than the standard
treatment (TAU) for changing point of view in patients with psychotic
disorders. 1e) Metacognitive training is more effective than the standard
treatment (TAU) for changing quality of life in patients with psychotic
disorders. 1f) Metacognitive training is more effective than the standard
treatment (TAU) for changing ideas of social inference in patients with
psychotic disorders. 1g) Metacognitive training is more effective than the
standard treatment (TAU) for changing subjective cognitive functioning in
patients with psychotic disorders. 1h) Metacognitive training is more effective
than the standard treatment (TAU) for changing cognitive insight in patients
with psychotic disorders. 1i) Metacognitive training is more effective than the
standard treatment (TAU) for changing metacognitions in patients with psychotic
disorders. 1j) Metacognitive training is more effective than the standard
treatment (TAU) for changing depressive symptoms in patients with psychotic
disorders.
In addition, the impact of the presence and severity of the symptom hearing
voices will be investigated. Furthermore, predictors for treatment success will
be sought and an analysis of cost-effectiveness will be made.
Study design
Design: The proposed study will employ a multi-center randomized controlled
trial. We expect the MCT+TAU group to do better than the TAU only group
(control group). Data collection for the pre-test will take place prior to the
intervention (t0), the post-test data will be collected immediately following
the intervention (t1) and follow-up data will be collected at 4 months after
the intervention (t2). All data collection will be blinded.
Interventions:
Metacognitive Training (MCT): MT is a group intervention intended for 3-10
patients. Sessions are typically conducted either by a clinical psychologist,
psychiatrist, occupational therapist or psychiatric nurse. Each of the eight
sessions lasts 45-60 minutes and deals with specific cognitive bias. In each
module, patients are first familiarized with the target domain (e.g.,
attributional style, jumping to conclusions, theory of mind) by means of a
number of everyday examples and illustrations. To emphasize the relevance of
the modules for psychosis and to ensure a lasting impact on patients, the
linkage of these biases with psychosis formation/maintenance is repeated at the
end of each session an eventually elucidated with anecdotal accounts of
psychosis. Excercises form the core of the modules. Patients practice to
counteract cognitive biases such as jumping to conclusions. Leaflets with
homework and discussions about symptoms of the participants personalize and
generalize the practiced skills into the daily life of the patients. Patients
will participate in two sessions per week. After four weeks six different kinds
of cognitive bias have been discussed and trained: attribution, jumping to
conclusions (2x), memory, to empathize (2x), changing beliefs and self-esteem
and mood.
Treatment as usual (TAU): concerns standard treatment for psychotic patients,
which consist of medication prescribed by a psychiatrist and outpatient
treatment by a social-psychiatrist nurse and/or psychologist.
Intervention
MCT is a group intervention intended for 3-10 patients. Sessions are typically
conducted either by a clinical psychologist, psychiatrist, occupational
therapist or psychiatric nurse. Each of the eight sessions lasts 45-60 minutes
and deals with specific cognitive aberration. In each module, patients are
first familiarized with the target domain (e.g., attributional style, jumping
to conclusions, theory of mind) by means of a num-ber of everyday examples and
illustrations. To emphasize the relevance of the modules for psychosis and to
ensure a lasting impact on patients, the linkage of these biases with psychosis
formation/maintenance is repeated at the end of each session an eventually
elucidated with anecdotal accounts of psychosis. Excercises form the core of
the modules. Patients practice to counteract cognitive biases such as jumping
to conclusions. Leaflets with homework and discussions about symptoms of the
participants personalize and generalize the practiced skills into the daily
life of the patients. Treatment as usual (TAU): concerns standard treatment for
psychotic patients, which consist of medication prescribed by a psychiatrist
and outpatient treatment by a social-psychiatrist nurse and/or psychologist
Study burden and risks
Patient will make 12 visits to their local mental health institution. Four of
the visits consist of screening and measurements and will take about 90
minutes. The other 8 visits consist of the MCT-sessions en will take a maximum
of 90 minutes.
Ethical issues are also considered:
-first of all we agreed that treatment as usual should be continued during the
length of the study. Also medical treatment will be continued.
-We also conducted a pilot study testing the feasibility and patients agreed
that the training was fun and it was not too heavy.
-patients are informed about the fact that they can withdraw from the study at
any given point without any further explanation.
-Decent time-management should garantuee that patients won't have to visit the
institution too often.
-because of negative symptoms the training will take place in the second part
of the day.
Postbus 70058
5201 DZ 's-Hertogenbosch
NL
Postbus 70058
5201 DZ 's-Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
-patients with schizophrenia and/or another psychotic disorder (established with SCAN)
-With delusional symptoms (established with PANNS, PSYRATS and GPTS)
-age between 18-65
Exclusion criteria
-primairy addiction
-insufficient understanding of the dutch language
-IQ<70
Design
Recruitment
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 | NL28883.097.09 |