Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders

NCT06423651 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-05-23

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are:

* Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)?
* What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account?
* What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term?

Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery.

Participants will:

* Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy.
* Do 8 weekly sessions of 45-60 minutes (MCT group).
* Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group).
* Visit the clinic for checkups and tests.
* Answer self-administered tests.

Conditions

  • Schizophrenia
  • Schizophreniform Disorders
  • Delusional Disorder
  • Brief Psychotic Disorder
  • Schizoaffective Disorder
  • Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

BEHAVIORAL

Cognitive Remediation (REHACOP)

REHACOP is a structured neuropsychological rehabilitation program that covers most of the cognitive deficits present in psychotic disorder: attention, learning and memory, executive functions, language, social cognition, daily life activities, social skills and psychoeducation. The modules of language, social cognition and psychoeducation will not be used in the present clinical trial. Each module includes a hierarchy of exercises based on the cognitive subarea to be worked on and the grade of difficulty demanded for the performance of each task.The format of the sessions will be the same as MCT, that is, groups of 6-10 patients who will receive weekly sessions of 45-60 minutes in length. In this case, the duration of the intervention will be 12 sessions.

BEHAVIORAL

Metacognitive Training (MCT)

The MCT consists in 8 weekly sessions of 45-60 minutes in length. Each group of patients should be made up of 6-10 patients. The material of the training program is available online at: http://www.uke.de/mkt. The material contains 16 powerpoint presentations (2 per each module), one manual and 6 pamphlets of tasks to do at home. The modules are as follows: Module 1: Attribution; Module 2: Jumping to conclusions (1st part); Module 3: Changing beliefs; Module 4: To emphatise (1st part); Module 5: Memory; Module 6: To emphatise (2nd part); Module 7: Jumping to conclusions (2nd part); and Module 8: Self-esteem and mood.

Sponsors & Collaborators

  • Parc Sanitari Sant Joan de Déu

    collaborator OTHER
  • Consorci Sanitari de Terrassa

    collaborator OTHER
  • Hospital de Mataró

    collaborator OTHER
  • Centre d'Higiene Mental Les Corts

    collaborator OTHER
  • Fundació Els 3 Turons

    collaborator UNKNOWN
  • Hospital San Carlos, Madrid

    collaborator OTHER
  • Andaluz Health Service

    collaborator OTHER_GOV
  • Institut d'Assistència Sanitària

    collaborator OTHER
  • Ministerio de Ciencia, Innovación y Universidades

    collaborator UNKNOWN
  • Hospital Son Espases

    collaborator OTHER
  • Parc Taulí Hospital Universitari

    collaborator OTHER
  • Servicio Cántabro de Salud

    collaborator OTHER
  • Universitat Autonoma de Barcelona

    lead OTHER

Principal Investigators

  • Ana Barajas Velez · Universitat Autonoma de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423651 on ClinicalTrials.gov