Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.

Psychosis Clinical Trial

Official title:

Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340559
• Other study ID #: PI11/01347
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 20, 2015
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms.

The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by EMC in the insight of each session and the maintenance of the effects of EMC program at six months of treatment.

Description:

The study is a randomized clinical trial in which a group will receive the Meta-Cognitive Training (EMC) and a control group will receive a journal workshop.

The evaluator will be blind to the group that owns the patients included. The total simple will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score at or above 3 on the PANSS during the last year. Patients should be attended in one of the next services: Parc Sanitari Sant Joan de Déu, Corporació Sanitària Parc Taulí, Hospital de la Santa Creu i Sant Pau, Hospital Clínic de Valencia, Centre d´Higiene Mental de les Corts, Institut d´Assitència Sanitària Girona, Servicio Andaluz de Granada, Málaga y Jaén. The assessment was performed at baseline, at the end of treatment and six month follow-up.

The assessment includes: psychopathology and insight ( PANSS, PSYRATS, PDI, GAF, BDI, BCIS, Sumd), meta-cognition (jumping to conclusions, IPSAQ, TCI), neuropsychology (WCST, TMT, CPT-II, TAVEC, WAIS) and social functioning and quality of life (EFS, DAS-SV, SLDS). The insight will be assessed at the final of each session (BCIS). The treatment and control group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. The EMC group material is translated and validated in Spanish by investigators of the team.

The primary analysis variable is the difference between the scores of experimental and control group in the symptoms scales (especially positive). Secondary outcomes will change in other assessments of social functioning, metacognition (cognitive distortions and theory of mind) and neuropsychological variables. Were analyzed using regression and ANCOVA methods with SPSS 19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.

• Less than 5 years of evolution.

• Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).

Exclusion Criteria:

• Neurological disorder which impairs cognition.

• Intellectual Disability.

• Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Meta-cognitive Training

• Psychoeducational group

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Centro de Higiene Mental Les Corts, Corporacion Parc Tauli, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Fundación para la Investigación del Hospital Clínico de Valencia, Institut d´Assistència Sanitària Girona, Parc Sanitari Sant Joan de Déu, Servicio Andaluz de Salud de Granada, Málaga y Jaén

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SFS "Social Functioning Scale"	This scale assess social functioning in people with psychotic disorders (Birchwood et al, 1990; Torres y Olivares, 2000).	baseline, 2 months (post-treatment) and 6 months of follow-up.	No
Other	Neuropsychological battery	A neuropsychological battery was included. The test included were WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)measure of executive function; Test Stroop (Stroop, 1935) flexibility and inhibition of automatic responses; TMTA-B (Trail Making Test, Reitan, 1993) visual attention and task switching; CPT (Continous Performance Test, Conners 2000) this scale asses inattentiveness and impulsivity; TAVEC (Test Aprendizaje Verbal España Complutense, Benedet and Aleixandre 1998) this scale asses memory; WAIS (Weschler Adults Intelligence Scale, Wechsler 1955)subscales of digits and vocabulary.	baseline and 6 months of follow-up.	No
Primary	PANSS. Positive and Negative Syndrome Scale	The Positive and Negative Syndrome Scale (PANSS)(Kay et al., 1987; Peralta and Cuesta, 1994) measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.	baseline, 2 months (post-treatment) and 6 months of follow-up	No
Primary	PSYRATS. Psychotic Symptoms Rating Scale	The PSYRATS (Haddock et al, 1999; Gonzalez et al, 2003). This scale assess delusions in 6 items.	baseline, 2 months (post-treatment) and 6 months of follow-up	No
Secondary	Jumping to conclusions	Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.	baseline, 2 months (post-treatment) and 6 months of follow-up	No
Secondary	BCIS. Beck Cognitive and Insight Scale	The Beck Cognitive Insight Scale (BCSI; Beck et al., 2004; Gutierrez-Zotes et al., 2012) is a self-registering measure of 15 items which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).	baseline, 2 months (post-treatment) and 6 months of follow-up. Moreover in the intervention group this scale was assessed at the end of each session	No
Secondary	IPSAQ. Internal, Personal and Situational Attribution Questionnaire.	The scale assess the attributional style in 32 situations.	baseline, 2 months (post-treatment) and 6 months of follow-up.	No
Secondary	Hinking Task	The Scale assess Theory of Mind. For the porpouse of the study we selected 3 different situations in each assessment	baseline, 2 months (post-treatment) and 6 months of follow-up.	No
Secondary	TCI scale "Test de Creencias Irracionales"	This scale assess irrational beliefs in ten subscales:Need for acceptance by others, High self-expectations, blame, Intolerance to frustration, Worry and anxiety, Emotional irresponsibility, Avoidance of problems, dependency, helplessness, perfectionism.	baseline, 2 months (post-treatment) and 6 months of follow-up.	No