NCT02187692

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

October 14, 2013

Last Update Submit

July 10, 2014

Conditions

Keywords

schizophrenia;meta-cognition;general functioning;positive symptoms;insight;

Outcome Measures

Primary Outcomes (2)

  • 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.

    week 0

  • [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.

    week 4-5

Secondary Outcomes (2)

  • Cognitive Biases Questionnairre for Psychosis (CBQp)

    week 0

  • [Change] Cognitive Biases Questionnairre for Psychosis (CBQp)

    week 4-5

Other Outcomes (2)

  • Neurocognition

    week 0

  • [Change] Neurocognition

    week 4-5

Study Arms (2)

TAU

NO INTERVENTION

Treatment 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.

MCT

EXPERIMENTAL

Treatment 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.

Behavioral: MCT

Interventions

MCTBEHAVIORAL

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.

MCT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • neurological diseases
  • substance abuse
  • severe psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

II Department of Psychiatry, Medical University of Warsaw

Warsaw, 02-243, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Łukasz Gawęda, PhD

    II Department of Psychiatry, Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 14, 2013

First Posted

July 11, 2014

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

July 11, 2014

Record last verified: 2013-10

Locations