Clinical trial NCT04429412: Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Official title: Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brief Psychotic Disorder
Psychosis; Episode
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Servicio Andaluz Jaén y Málaga
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Parc de Salut Mar
name: Centre d'Higiene Mental Les Corts
name: Institut Pere Mata
name: Institut Assistència Sanitària Girona
name: Hospital Clínico Universitario de Valencia
First posted: 2020-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
timeFrame: baseline.
measure: PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
timeFrame: immediately after the intervention
measure: PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Jumping to conclusions. (Brett-Jones et al. 1987).
timeFrame: baseline
measure: Jumping to conclusions. (Brett-Jones et al. 1987).
timeFrame: immediately after the intervention
measure: Jumping to conclusions. (Brett-Jones et al. 1987).
timeFrame: 6 months follow-up
measure: BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: baseline
measure: BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: immediately after the intervention
measure: BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: 6 months follow-up
measure: IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
timeFrame: baseline
measure: IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
timeFrame: immediately after the intervention
measure: IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
timeFrame: 6 months follow-up
measure: The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
timeFrame: baseline
measure: The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
timeFrame: immediately after the intervention
measure: The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
timeFrame: 6 months follow-up
measure: Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
timeFrame: baseline
measure: Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
timeFrame: immediately after the intervention
measure: Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
timeFrame: 6 months follow-up
measure: MASC. (Lahera et al.2014).
timeFrame: immediately after the intervention
Other outcomes:
measure: SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
timeFrame: baseline
measure: SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
timeFrame: immediately after the intervention
measure: SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
timeFrame: 6 months follow-up
measure: WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
timeFrame: baseline
measure: WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
timeFrame: immediately after the intervention
measure: WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
timeFrame: 6 months follow-up
measure: Test Stroop (Stroop, 1935)
timeFrame: baseline
measure: Test Stroop (Stroop, 1935)
timeFrame: immediately after the intervention
measure: Test Stroop (Stroop, 1935)
timeFrame: 6 months follow-up
measure: TMT A B (Trail Making Test, Reitan, 1993)
timeFrame: baseline
measure: TMT A B (Trail Making Test, Reitan, 1993)
timeFrame: immediately after the intervention
measure: TMT A B (Trail Making Test, Reitan, 1993)
timeFrame: 6 months follow-up
measure: CPT-IP (Continous Performance Test, Matrics)
timeFrame: baseline
measure: CPT-IP (Continous Performance Test, Matrics)
timeFrame: 6 months follow-up
measure: TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)
timeFrame: baseline
measure: TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)
timeFrame: 6 months follow-up
measure: WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
timeFrame: baseline
measure: WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
timeFrame: baseline
measure: WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
timeFrame: immediately after the intervention
measure: WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
timeFrame: 6 months follow-up
Locations:
Study officials:
References: