This study examines whether MCT is effective in patients with schizophrenia-spectrum disorder and comorbid GAD. It is expected that:a) MCT leads to a significant decrease in worryingb) MCT leads to significant reduction of psychotic symptomsc) The…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the Penn State Worry Questionnaire (PSWQ), a
reliable and valid self-report questionnaire to chart persistent, excessive and
uncontrollable worry. The list consists of 16 items that are scored on a
five-point Likert scale. The total score can vary from 16 to 80. This
questionnaire is administered at all measuring moments.
At group level, it is verified by means of paired t-tests whether worrying is
stable during the baseline period (measurement 1 and measurement 3). Effects of
MCT on worry, delusions and metacognitions are also examined by means of paired
t-tests (measurement 3 and measurement 4). In order to check whether the
effects found are maintained afterwards, paired t-tests are also performed
(measurement 4 and measurement 5). The size of the effects (effect sizes) is
calculated using Cohen's d (M1 - M2 / pooled SD, Cohen, 1992). All statistical
analyzes will be performed using SPSS, version 23.
At the individual level, two widely used methods are used in case series
research, the evaluation of the graphical representation of changes in symptoms
over time (Parsonson & Baer, **1992), and the more conservative method of
mapping the clinical significance. for the primary outcome measure, the PSWQ,
using the procedures described by Jacobson and Truax (1991). According to this
method, patients are considered recovered if a) their score on a particular
questionnaire after the end of the treatment falls within the normal range of
scores (ie below a set cut-off point), and b) the difference between the
starting and final score on that questionnaire reflects a statistically
reliable improvement (ie a difference score greater than a set Reliable Change
Index [RCI]). Based on the normative data of the Dutch version of the PSWQ, the
RCI was set at 7 and the cut-off point at 53 (Van der Heiden et al., 2012).
Secondary outcome
In addition to the primary outcome measures, the following questionnaires are
taken:
The PSYRATS is a semi-structured interview consisting of eleven items that
measure aspects of hallucinations and six items that map characteristics of
delusions. The items are scored on a 5-point Likert scale running from 0-4 and
cover the past week. Items related to preoccupation, duration, conviction and
disruption form the factor 'cognitive interpretation', items that deal with the
frequency and intensity of experienced distress constitute the second factor,
'emotional impact'.
The remission tool-PANNS is a semi-structured interview in which 7 areas,
corresponding to the characteristics of the schizophrenia-spectrum disorder,
are questioned. It concerns the areas Delusions and unusual thought content;
Conceptual disorganization; Hallucinations; Passive / apathetic withdrawal;
Lack of spontaneity; Feeling dulled; Mannerism and poses. This questionnaire is
part of the standard ROM and is not an extra list.
The MCQ-30 is a self-report questionnaire that maps out individual differences
in positive opinions about worrying, negative views about worrying, opinions
about the need to keep control over one's own thoughts, cognitive
self-awareness, and cognitive self-confidence. The list consists of 30
questions scored on a 4-point Likert scale, ranging from 'disagree' (1) to
'very strongly agree' (4). For this study only the subscales positive and
negative views on worrying will be used. The psychometric qualities of the
MCQ-30 are good (Hermans, Crombez, Van Rijsoort & Laeremans, 2002).
A final outcome measure is the already described GAD-7 (Spitzer et al., 2006),
which is taken before participation (for inclusion), at the start of the
treatment and then at the end of the treatment and at the follow-up
measurement.
Background summary
Worrying is an important comorbid problem in patients with
schizophrenia-spectrum disorder. Worrying is, in addition to insomnia, the
strongest predictor of a later psychosis, and is associated with the
maintenance of delusions. 68% of patients with delusions worries to an extent
comparable to patients with generalized anxiety disorder (GAD), a disorder of
which persistent uncontrollable worrying about various issues is the central
feature. In almost 11% of cases psychotic patients even meet the criteria of a
(comorbid) GAD. Although several studies have shown that treatment of worrying
with cognitive behavioral therapy leads to a decrease in both worrying and
delusions in patients with perspiration delusions, no research has yet been
done into the treatment of comorbid GAD in this target group.
In this study it will be investigated whether metacognitive therapy (MCT) for
GAD is effective in patients with schizophrenia-spectrum disorder. MCT is an
effective treatment for GAD and is one of the psychological treatments of first
preference for GAD (NHS, 2012). The interventions in this treatment are not
focused on the worrying itself, but on the views that someone has about his /
her worry, the so-called metacognitions. Positive opinions about worrying, such
as 'I'm well prepared for possible problems', are seen as a factor that
contributes to the maintenance of worrying. Negative views about worrying, such
as 'worrying is uncontrollable' and 'worrying makes me go crazy', are seen as
crucial for the development of GAD. They lead to 'worrying about worrying' and
an increase in feelings of fear, and counterproductive attempts to prevent or
control the worrying once it has started.
Interesting in this context is that such metacognitive views are associated
with psychotic experiences, the perceived stress as a result of these
experiences and with negative affect. It is possible that even transitions can
be prevented with MCT for GAD. Morrison, French and Wells (2007) found
indications that negative metacognitions make patients susceptible to anxiety,
but positive metacognitions (MCs) for psychoses. However, this can not be
determined within the current study.
No previous studies have been conducted on the treatment of GAD in this target
group.
Study objective
This study examines whether MCT is effective in patients with
schizophrenia-spectrum disorder and comorbid GAD. It is expected that:
a) MCT leads to a significant decrease in worrying
b) MCT leads to significant reduction of psychotic symptoms
c) The decrease in complaints is retained at follow-up after 3 months
Study design
The study was set up as a case-based time series design with baseline
measurement (a so-called ABA design). This design is ideally suited to verify
in clinical practice whether a proven effective treatment for a particular
disorder (ie GAD) is also suitable for patients with a different primary
disorder (ie, a schizophrenia-spectrum disorder with comorbid GAD), without
requiring large numbers of participants, control conditions and / or
randomisation procedures.
Intervention
After informed consent, patients are offered fourteen weekly MCT sessions for
GAD, cf. Van der Heiden's protocol (2017). This treatment takes place alongside
the regular treatment for psychotic complaints. The treatments are performed by
three registered cognitive-behavioral therapists from Parnassia The Hague, who
were trained and supervised by the principal investigator (CH) in the
application of the MCT protocol to GAD in some patients from their own caseload
who met the inclusion criteria. Each therapist treats three patients with MCT
within the study.
Study burden and risks
It is estimated that completing the questionnaires takes a maximum of 30
(measurements 1 and 2) to 90 minutes (measurement 3-5) per session. The patient
is asked to complete questionnaires at 5 moments, namely 2 and 1 week before
start of treatment, at start of treatment, at the end of treatment and 3 months
after completion of treatment (follow up).
The burden of research is relatively small, while, as far as we know, there are
no risks associated with participation in the research.
The treatment method to be investigated (metacognitive therapy) is part of the
cognitive behavioral therapy and is considered to be the treatment of first
preference in generalized anxiety disorder.
President Kennedylaan 15
Den Haag 2517JK
NL
President Kennedylaan 15
Den Haag 2517JK
NL
Listed location countries
Age
Inclusion criteria
1. Age between 18-65;
2. primary diagnosis of schizophrenia-spectrum disorder according to DSM-5
3. A score of 10 or higher on the GAD-7, a diagnostic screening list for GAD
4. A clinically significant degree of worrying, shown by a high score (* 49) on
the Penn State Worry Questionnaire
5. In case of intended radical changes in the field of pharmacotherapy,
patients can only enter the study if the dose is stable for at least one month.
Exclusion criteria
Patients are excluded when:
1. they are unable or seem unable to give informed consent;
2. they don't sufficiently master the dutch language to undergo treatment
without an interpreter
3. there is alcohol or drug abuse that interferes with treatment
4. they have an IQ of 70 or below
5. they have an organic disorder
Design
Recruitment
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 | NL67665.058.18 |