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

NCT02340559 | Completed

• 1 other identifier: PI11/01347
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psychosis

Keywords

meta-cognition; positive symptoms; early phases; schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Jumping to conclusions

  baseline, 2 months (post-treatment) and 6 months of follow-up

• BCIS. Beck Cognitive and Insight Scale

  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

• IPSAQ. Internal, Personal and Situational Attribution Questionnaire.

  baseline, 2 months (post-treatment) and 6 months of follow-up.

• Hinking Task

  baseline, 2 months (post-treatment) and 6 months of follow-up.

• TCI scale "Test de Creencias Irracionales"

  baseline, 2 months (post-treatment) and 6 months of follow-up.

Other Outcomes (2)

• SFS "Social Functioning Scale"

  baseline, 2 months (post-treatment) and 6 months of follow-up.

• Neuropsychological battery

  baseline and 6 months of follow-up.

Study Arms (2)

Meta-cognitive Training

EXPERIMENTAL

The metacognitive training program is comprised of eight modules targeting common cognitive errors in schizophrenia. The modules are : attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8). The treatment group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.

Behavioral: Psychoeducational group

Psychoeducational group

ACTIVE COMPARATOR

In the control group the modules worked were: 1. Healthy Habits, 2. Risk Behaviors, 3. Prevention of relapse, 4 and 5.Videoforum, 6. Resources of work and development of curriculum vitae 7. Leisure activities, and 8. Resources of the community. The psychoeducational group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.

Behavioral: Meta-cognitive Training

Interventions

Meta-cognitive Training BEHAVIORAL

Psychoeducational group

Psychoeducational group BEHAVIORAL

Meta-cognitive Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Related Publications (1)

• Salas-Sender M, Lopez-Carrilero R, Barajas A, Lorente-Rovira E, Pousa E, Barrigon ML, Grasa E, Ruiz-Delgado I, Gonzalez-Higueras F, Cid J, Aznar A, Pelaez T, Birules I, Moritz S, The Spanish Metacognition Study Group, Ochoa S. Gender differences in response to metacognitive training in people with first-episode psychosis. J Consult Clin Psychol. 2020 Jun;88(6):516-525. doi: 10.1037/ccp0000468. Epub 2019 Dec 19.

  PMID: 31855037 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Susana Ochoa, PhD

  Parc Sanitari Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

• Marisa Barrigón, PhD

  Servicio Andaluz de Salud. Granada

  STUDY CHAIR

• Fermín González

  Servicio Andaluz de Salud. Jaen

  STUDY CHAIR

• Isabel Ruiz

  Servicio Andaluz de Salud. Málaga

  STUDY CHAIR

• Eva Grasa

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY CHAIR

• Esther Pousa, PhD

  Corporacion Parc Tauli

  STUDY CHAIR

• Esther Lorente, PhD

  Hospital Clínic de València

  STUDY CHAIR

• Ana Barajas

  Centre d'Higiene Mental de les Corts

  STUDY CHAIR

• Jordi Cid

  Institut d'Assistència Sanitària de Girona

  STUDY CHAIR

• Raquel López, MS

  Parc Sanitari Sant Joan de Déu

  STUDY CHAIR

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: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01