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Clinical Trials/NCT04429412
NCT04429412
Completed
Not Applicable

Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution

Fundació Sant Joan de Déu0 sites70 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brief Psychotic Disorder
Sponsor
Fundació Sant Joan de Déu
Enrollment
70
Primary Endpoint
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.

Detailed Description

This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.The evaluator will be blind to the group to which the patients belong. The sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score =\> 3 positive PANSS (last month) and treated in one of the participating institutions. The evaluation was performed at baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial and neuropsychological functioning were assessed. The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material available for the Individualized Metacognitive Training (EMC) program is made up of power-point presentations.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
September 1, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
  • Substance dependence.
  • Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).

Outcomes

Primary Outcomes

PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)

Time Frame: 6 months follow-up

The Positive and Negative Syndrome Scale (PANSS). This scale 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.Range: 7-112. Higher values represent a worse outcome.

Secondary Outcomes

  • BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)(6 months follow-up)
  • The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)(6 months follow-up)
  • Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)(6 months follow-up)
  • MASC. (Lahera et al.2014).(immediately after the intervention)
  • Jumping to conclusions. (Brett-Jones et al. 1987).(6 months follow-up)
  • IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)(6 months follow-up)

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