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

NCT04429412 | Completed

• 1 other identifier: PI14/00044
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brief Psychotic Disorder; Psychosis; Episode

Outcome Measures

Primary Outcomes (3)

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

  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.

  baseline.

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

  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.

  immediately after the intervention

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

  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.

  6 months follow-up

Secondary Outcomes (16)

• Jumping to conclusions. (Brett-Jones et al. 1987).

  baseline

• Jumping to conclusions. (Brett-Jones et al. 1987).

  immediately after the intervention

• Jumping to conclusions. (Brett-Jones et al. 1987).

  6 months follow-up

• BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)

  baseline

• BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)

  immediately after the intervention

Other Outcomes (20)

• SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

  baseline

• SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

  immediately after the intervention

• SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).

  6 months follow-up

Study Arms (2)

Metacognitive Training (MCT+)

EXPERIMENTAL

MCT+ combines the process-oriented approach of metacognitive group training with elements of individual cognitive-behavioral therapy. The metacognitive training program is comprised of 10 modules targeting common cognitive errors in schizophrenia. (Moritz et al, 2013). The modules are: 1:Therapeutic alliance, 2: Introducyion to MCT+, 3:Disease model, 4: Attributional style, 5: Decision making, 6: Changing beliefs, 7: Empathizing, 8: Memory, 9: Depression and self-steem, 10: Relapse prevention. The treatment consist of 10 weekly sessions of 45-60 minutes.

Behavioral: MCT+

TAU

NO INTERVENTION

Treatment as usual.

Interventions

MCT+ BEHAVIORAL

Metacognitive training

Metacognitive Training (MCT+)

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:

• 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).

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Parc Sanitari Sant Joan de Déu: collaborator
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Servicio Andaluz Jaén y Málaga: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Parc de Salut Mar: collaborator
• Centre d'Higiene Mental Les Corts: collaborator
• Institut Pere Mata: collaborator
• Institut Assistència Sanitària Girona: collaborator
• Hospital Clínico Universitario de Valencia: collaborator

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blind to the group that owns the patients included.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 12, 2020
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2018
• Last Updated: June 12, 2020

Record last verified: 2020-05