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

NCT06423651 | Recruiting DMC

• 1 other identifier: PID2020-118907RA-I00
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metacognitive Training; MCT; Cognitive Remediation; Psychotic disorder; Psychosis; Cognitive functions; Cognitive biases; Neurocognitive improvement

Outcome Measures

Primary Outcomes (2)

• CLINICAL RECOVERY

  Includes: a) CLINICAL REMISSION: based on the criteria of the Remission in Schizophrenia Working Group (RSWA) of Andreasen et al. (2005), which includes one criterium of severity measured with 7 items of the PANSS scale and one temporal criterium that requires the maintenance of the criterium of severity during 6 months or more; and b) FUNCTIONAL RECOVERY: based on the criteria defined by the German Research Network on Schizophrenia (GRNS group) (Schennach-Wolff et al., 2009), which includes one criterium of severity based on the GAF scale and one temporal criterium of maintaining the criterium of severity during 6 months or more.

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

• FUNCTIONAL RECOVERY

  To be measured with the STORI test.

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

Secondary Outcomes (24)

• Assesment instruments

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

• Social Cognition. Recognition of emotion

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

• Social Cognition. Hinting Task (Corcoran et al., 1995; Gil et al., 2012)

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

• Social Cognition. Internal, Personal and Situational Attributions Questionnaire (IPSAQ) (Kinderman & Bentall, 1996; Diez-Alegría, 2006)

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

• Ball task (Dudley et al.,1997).

  It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.

Study Arms (2)

REHACOP+MCT therapy

EXPERIMENTAL

The participants will receive a combined therapy: Metacognitive Training (MCT) with Cognitive Remediation (CR).

Behavioral: Cognitive Remediation (REHACOP); Behavioral: Metacognitive Training (MCT)

MCT alone

ACTIVE COMPARATOR

The participants will receive Metacognitive Training (MCT)

Behavioral: Metacognitive Training (MCT)

Interventions

Cognitive Remediation (REHACOP) BEHAVIORAL

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.

REHACOP+MCT therapy

Metacognitive Training (MCT) BEHAVIORAL

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.

MCT alone; REHACOP+MCT therapy

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of one of the e following diagnostics according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): schizophrenia, schizophreniform disorder, delusional disorder, brief psychotic disorder, schizoaffective disorder, and non specified schizophrenia spectrum disorder and other psychotic disorders.
• Be in a stable clinical phase (without psychiatric hospitalization in the last 3 months).
• Have good adherence to pharmacological treatment.
• T-score \< 40 in any cognitive outcome measured by TAVEC, CPT-IP, TMT, Stroop, WSCT, FAS and WAIS (Vocabulary, Digit Forward, Digit Backwards and Digit Symbol Coding.
• Willing to participate in the study expressed by providing signed informed consent.

You may not qualify if:

• Presence of traumatic brain lesion, dementia or intellectual discapacity (IQ \<70).
• Positive and Negative Syndrome Scale (PANSS) score \>= 5 in hostility and lack of cooperation and \>= 6 in suspiciousness.
• Presence of an additional diagnosis of severe disorder related to substances.
• Having participated in a CR and/or MCT intervention in the year prior to incorporation into the study.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead
• Parc Sanitari Sant Joan de Déu: collaborator
• Consorci Sanitari de Terrassa: collaborator
• Hospital de Mataró: collaborator
• Centre d'Higiene Mental Les Corts: collaborator
• Fundació Els 3 Turons: collaborator
• Hospital San Carlos, Madrid: collaborator
• Andaluz Health Service: collaborator
• Institut d'Assistència Sanitària: collaborator
• Ministerio de Ciencia, Innovación y Universidades: collaborator
• Hospital Son Espases: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Servicio Cántabro de Salud: collaborator

Study Sites (1)

Universitat Autonoma de Barcelona

Cerdanyola del Vallès, Barcelona, 08193, Spain

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid; Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ana Barajas Velez

  Universitat Autonoma de Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Barajas Velez

CONTACT

+34935814452; ana.barajas@uab.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a randomized clinical trial in which one group will receive combined REHACOP + MCT therapy and another group will receive therapy with MCT alone. The metacognitive treatment will have the same characteristics in the two treatment conditions. Randomisation of the patients for receiving one of the two treatments will be carried out using a random number list based on the order of access to their reference centre. The evaluator will be blinded to the treatment group to which the patient assessed belongs.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

ES (1)