The Effectiveness of the Meta-cognitive Training Among Patients With Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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 ).
    

Intervention name(s): MCT
Intervention type(s): Behavioral
Intervention description(s): The meta-cognitive training (the MCT) consists of eight structurized psychological therapy modules that provides basic knowledge about cognitive biases that are associated with schizophrenia and it provides the sklills how to overcome negative consequences of the biases. The MCT includes: Module 1 manages self-serving bias (i.e. external-personal attribution for failure, internal attribution for positive events); Module 2 and 7 target the jumping to conclusion; Module 3 and 7 concern beliefs flexibility and bias against disconfirmatory evidence; Module 4 and 6 target deficits in theory of mind; Module 5 is devote to ameliorate the cognitive over-confidence in false memories; Module 8 deals with depressive thinking style.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia;; meta-cognition;; general functioning;; positive symptoms;; insight;