Schizophrenia Clinical Trial
Official title:
The Effectiveness of The Meta-cognitive Training Among Chronic Schizophrenia Patients Treated Within Community Support Groups in Poland.
The aim of the study is to compare the effectiveness of the meta-cognitive training (MCT) for schizophrenia against treatment as usual (TAU) among patients who attends community support groups. 4 weeks of MCT will be administered for patients two times per week. MCT consists of well structured cognitive behavioral therapy interventions. MCT will be administered according authors recommendations. All participants will be assessed at baseline (T0) and up to one week after the MCT intervention (T1, 4-5 week of the study).
50 patients with established schizophrenia diagnosis will be included and randomized into
two conditions: MCT (n= 25) and TAU (n=25). Exclusion criteria are: neurological diseases,
substance dependence (alcohol and drugs).
A broad outcome measures will be provided including symptoms severity, cognitive biases,
neurocognition, insight and social functioning. Changes in variable after the intervention
will be compared between two condition.
Only patients with established schizophrenia with no neurological diseases will be included.
All patients will be assessed at two time points: T0 - at baseline, up to one week before
the intervention starts and T1 up to one week after the intervention is finished. T1
assessment will be at 4-5 weeks after the study begun.
Measures
1. General functioning General Assessment of Functioning was used as a measure of the
severity of patients' functional disabilities.
2. Insigh A questionnaire of insight into schizophrenia consists of six items targeting
insight. The scale has a good reliability with Cronbach's alpha 0.8.
3. The subjective sense of influence on the course of schizophrenia The Brief Measure to
Assess Perception of the Self-influence on the Disease Course - Version for
Schizophrenia consists of five items targeting different aspects of subjective sense of
influence on the course of schizophrenia. The scale has satisfactory psychometric
properties (Cronbach's alpha= 0.78).
4, Psychotic symptoms The severity of delusions and hallucinations were assessed at the
baseline and after the intervention with the semi-structured Psychotic Symptom Rating Scale
(The PSYRATS). The PSYRATS comprises hallucination and delusions subscale, each design to
assess psychological aspects of the symptoms on a five point scale from 0 to 4. The items
for the hallucination scale are: frequency (PH1); duration (PH2); location (PH3); loudness
(PH4); beliefs regarding the origin of voices (PH5); amount of negative content of voices
(PH6); degree of negative content (PH7); amount of distress (PH8); intensity of distress
(PH9); disruption to life caused by voices (PH10); controlability of voices (PH11). The
delusion subscale consists of six items: amount of preoccupation with delusions (PD1);
duration of preoccupation with delusions (PD2); conviction (PD3); amount of distress (PD4);
intensity of distress (PD5); disruption to life caused by beliefs (PD6). The PSYRATS has
good psychometric properties and have been reported being sensitive to symptoms change over
time. In addition the Paranoia Checklist which comprises 18 items, each rated on 5 point
scale for frequency, distress and degree of conviction, was used in order to assess
delusional ideations. The participants were asked to state if they experience different
delusional ideation during the last week before filling out the questionnaire.
5. Cognitive Biases. Cognitive Biases Questionnaire for Psychosis consists of 30 vignettes
of everyday life scenarios. Participants are asked to imagine themselves as being in the
situation and then choose one out of four cognitive responses indicating specific cognitive
biases. CBQp comprises of seven subscales: anomalous perceptions (AP); threatening events
(TE); intentionalising (I); catastrophising (C); dichotomous thinking (DT); jumping to
conclusion (JTC); emotion based reasoning (ER).
In addition two behavioral tasks were used in order to assess the most prominent cognitive
biases in schizophrenia, that is to say jumping to conclusion and theory of mind deficits.
In the Fish Task the participants are presented with two lakes with different proportion of
grey and orange fishes. In the first lake (lake A) there is 80% grey and 20% of orange
fishes. The proportion of fishes in the lake B is reversed. Participants are presented with
the fisherman who stands between lakes to catch fishes, but he is allowed to do that only
from one lake during the entire experiment. Participants on the computer screen were
presented with fishes. Two responses were gathered: 1) the participant should make the
confidence judgment by indicating from 0-100% how confident they are regarding the fish is
from lake A or lake B; 2) whether the participant has enough evidences for the final
decision on the fish is from lake A or B. Two alternative versions of the Fish Task were
used for pre- and post-test. We analyzed a number of fishes that were considered by
participants for the final decision. The less fishes were considered the more the
participant has jumping to conclusions tendencies.
Reading the Mind from Eyes Test (RMET,) was used in order to assess the deficits in the
theory of mind. The test consists of 36 different faces pictures restricted to eyes area
only. Based on the face expression participant is asked to infer the emotional state of the
person presented on the picture. We split the original 36 pictures test into two separate
tests for the pre- and post-test. In addition to original test we included the conviction
question in which participants responded how confident they are in their decisions (100%
sure). The RMET test has good psychometric properties and has been used often in
schizophrenia.
6. Global neurocognitive functioning Trial making test (TMT) A and B was used to assess
global cognitive flexibility. TMT A test is design to test psychomotor speed and attention.
TMT B test targets the data on the cognitive flexibility.
All tests will be administered at T0 (baseline assessment up to one week before
intervention) and T1 (up to one week after the intervention ).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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