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SchizophreniaNCT02187692

The Effectiveness of the Meta-cognitive Training Among Patients With Chronic Schizophrenia

A study testing MCT in people with Schizophrenia, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
MCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePoland
Study dates
Aug 2012to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • schizophrenia diagnosis accotding to the ICD-10 criteria
  • attending local community support groups for psychitatric patients

Who cannot join

  • neurological diseases
  • substance abuse
  • severe psychotic symptoms

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • II Department of Psychiatry, Medical University of Warsaw

    Warsaw, 02-243

Other trials in Poland

About this study

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).

Read the 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.

  1. 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.

  1. 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 ).

Conditions
Schizophrenia
Being tested
MCT
Keywords
schizophrenia;, meta-cognition;, general functioning;, positive symptoms;, insight;
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MCTBehavioural

    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.

Study groups in NCT02187692
Study groupRoleWhat they receive
TAUNo interventionTreatment as Usual (TAU) vs meta-cogntive training (MCT) condition will be contrasted. In the TAU patients attend regular day programm that includes psychoeducation, social training, vocational rehabilitation, psychotherapy. The MCT condition is an active condition that includes structuralized therapy modules twice a week for four weeks (eight modules in total). There will be no additional differences in the interventions between two groups. Participants will be randomized from patients from the same population into two conditions.
MCTExperimentalTreatment as Usual (TAU) vs meta-cogntive training (MCT) condition will be contrasted. In the TAU patients attend regular day programm that includes psychoeducation, social training, vocational rehabilitation, psychotherapy. The MCT condition is an active condition that includes structuralized therapy modules twice a week for four weeks (eight modules in total). There will be no additional differences in the interventions between two groups. Participants will be randomized from patients from the same population into two conditions.
Receives: Behavioral: MCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychotic Symptom Rating Scale (The PSYRATS)

    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 comprises hallucination and delusions subscale, each design to assess psychological aspects of the symptoms on a five point scale from 0 to 4.

    Measured: week 0

  2. [change] Psychotic Symptom Rating Scale (The PSYRATS)

    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 comprises hallucination and delusions subscale, each design to assess psychological aspects of the symptoms on a five point scale from 0 to 4.

    Measured: week 4-5

Secondary outcomes (2)
  1. Cognitive Biases Questionnairre for Psychosis (CBQp)

    Cognitive Biases Questionnaire for Psychosis (CBQp) 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).

    Measured: week 0

  2. [Change] Cognitive Biases Questionnairre for Psychosis (CBQp)

    Cognitive Biases Questionnaire for Psychosis (CBQp) 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).

    Measured: week 4-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2014 (estimated)
  2. Study startAug 2012
  3. Primary completionApr 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187692
Sponsor's protocol ID
MCTPOLAND
Status last verified
Oct 2013
First submitted
14 Oct 2013
Last updated
11 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Gaweda L, Krezolek M, Olbrys J, Turska A, Kokoszka A. Decreasing self-reported cognitive biases and increasing clinical insight through meta-cognitive training in patients with chronic schizophrenia. J Behav Ther Exp Psychiatry. 2015 Sep;48:98-104. doi: 10.1016/j.jbtep.2015.02.002. Epub 2015 Mar 5.

    PubMed 25775947

Questions about this trial

What is this clinical trial studying?

A study testing MCT in people with Schizophrenia, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychotic Symptom Rating Scale (The PSYRATS) (time frame: week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187692, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.

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