SchizophreniaCR+MCTpNCT06423651
Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders
A study testing Cognitive Remediation (REHACOP) and Metacognitive Training (MCT) in people with Schizophrenia and Schizophreniform Disorders, run by Universitat Autonoma de Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorders, Delusional Disorder
- What is being tested?
- Cognitive Remediation (REHACOP) and Metacognitive Training (MCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Autonoma de Barcelona
Cerdanyola del Vallès, Barcelona, 08193
Ana Barajas Velez, +34935814452, ana.barajas@uab.cat
About this study
Official title: Benefits of Combining Metacognitive Training (MCT) With Cognitive Remediation (CR) in the Recovery of Patients With Psychotic Spectrum Disorders (CR+MCTp)
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?
Read more
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.
Read the detailed description
This project is aimed at responding to one of the Challenges of the Spanish Strategy for Science, Technology and Innovation, specifically Challenge 1: Health, demographic change and well-being. One of the work areas that are located within this challenge is the Clinical and Translational Research based on the evidence of scientific and technological knowledge.The present proposal is clearly within the framework of clinical-translational investigation, since most of the entities participating attend persons with psychotic disorders, thereby ensuring the translation of investigation to the clinical setting. In addition, this project includes investigators with wide experience in psychological interventions in the target population and with previous experience in investigation in this area. Lastly, it is of note that the benefits of this investigation are not only of a scientific nature but also involve clinical investigation with a direct repercussion on improvement in the health care of people with psychotic disorders, enabling the design of new strategies of psychological interventions. Besides, the present proposal is aimed at responding to the challenges of our society, contributing to covering the needs of persons with psychotic disorder as well as developing the most effective therapeutic strategies to improve aspects related to clinical and personal recovery. Specifically, this project will allow making changes that will improve the quality of health care to the target population incorporating the combinated use of scientifically proven therapeutic strategies to health care services. In short, this project aims to promote innovation in the provision of mental health services, being the starting point in analyzing the efficacy of combined psychological therapies versus monotherapies address to improve of metacognitive processes.
- General and specific objectives. General objective: Compare the efficacy of combined REHACOP + MCT therapy vs. MCT alone in persons with nonaffective psychotic disorder in terms of recovery.
Specific objectives:
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery (clinical remission and functional recovery, the latter understood in terms of cognitive, occupational and social functioning).
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on personal/psychological recovery.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on cognitive biases and social cognition.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to gender.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to self-esteem, quality of life and stigma.
- Evaluate the maintenance of the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery, personal recovery, cognitive biases and social cognition in the long term.
- Methodology
Design:
This will be a randomised 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 subjects: The sample will be made up of people with non-affective psychotic disorder who are attended in any of the centres participating in the study which belong to the following entities:Consorci Sanitari de Terrassa; Hospital de Mataró; Instituto de Investigación Biomédica de Gerona (IdIBG); Parc Sanitari Sant Joan de Déu; Asociación Centro de Higiene Mental Les Corts; Hospital Sierrallana-Tres Mares; and UGC Salud Mental de Jaén.
Sample size: Considering that the investigators have no preliminary data on our principal objective in relation to clinical and personal recovery, the score obtained in the global assessment of functioning (GAF) at follow-up will be taken as a measure of outcome, since it is implicated in both clinical and functional recovery. The investigators used the data published in the article by Ochoa et al. (2017) in order to calculate the required sample size for this study. In this article, a difference of means of 5.73 points (SD=11.51) is obtained in the GAF scale from baseline and the follow-up at 6 months after the intervention. With these data, the necessary sample size has been estimated with an alpha of 0.05 and a power of 0.8. Taking into account 20% of possible losses to follow-up, the sample size has been calculated as 160 cases, 80 in each experimental arm (REHACOP + MCT vs. MCT). In this way, taking into account that the intervention groups will be carried out in the health care centers of 7 different entities each will have to recruit 24 patients, 12 for each experimental condition.
Data collection: the professional who makes the referral of the patients to the study will be responsible for reviewing fulfillment of the inclusion and exclusion criteria. Patients fulfilling the inclusion criteria will receive an explanation of the study and if they accept to participate, they must provide signed informed consent. The evaluation will be carried out at 3 time points: T0 (basal assessment, prior to initiation of treatment). All the previously described scales will be administered; T1 (post-treatment evaluation), all the scales will be administered and, in addition, the satisfaction perceived with the interventions received will be evaluated; T2 (follow-up evaluation ) at 6 months after completing the intervention all the scales will again be administered. In addition, the number of relapses and hospitalizations during the time interval will be registered. Assessment of the PANSS and GAF should take into account the temporal criterium mentioned in the section of 'Outcomes'. A contingency plan will be considered in the event that difficulties are detected in carrying out any of the phases of the study due to external causes, such as the continuity of the COVID-19 pandemic. This plan will consist of the implementation of interventions and evaluations making use of new technologies. All the centers already have the adequate infrastructure to carry out the project under these conditions.
Data analysis: Firstly, the two groups will be compared with the aim of verifying that there are no significant differences at baseline to confirm that they are comparable after randomization. Comparisons of means for independent samples will be carried out using the Student's t-test for continuous variables and the Chi-square test for categorical variables. The variables of the principal analysis will be the difference between the scores of the two groups (REHACOP+MCT and MCT) in the scores of the scales assessing clinical and personal/psychological recovery. The secondary results will be the differences in other assessments of social functioning, cognitive biases, and social cognition on comparing the two experimental conditions. Changes in the scores of these scales will be analyzed using regression methods for repeated measures, with the post-treatment score of the scales as the dependent variable and the basal score and the REHACOP+MCT group as the co-variables. Temporal stability of the results at 6 months will be assessed using the follow-up score as the dependent variable and evaluating how this affects the basal score, post treatment and the experimental condition. The statistical analyses will be performed according to intention to treat (ITT) without imputing the lost values. Gender, antipsychotic medication, and disease evolution time will be considered as control variables.
Limitations:
One of the limitations of this clinical trial might be the loss to follow-up. To compensate for these losses the sample size will be increased by 20%. It is expected that the losses to follow-up will be similar in the two groups. Otherwise, this variable will be considered as an indicator of the acceptability of treatment.
- Ethical considerations: All the people who participate in the trial will sign the informed consent that takes into account the Declaration of Helsinki and the Organic Law 03/2018 of December 5. In the cases of minors informed consent will be signed by the legal guardians The project will be evaluated by each of the Ethics Committees of the participating centers.
Participants will be informed that the data obtained will only be used for purposes related to the investigation and data confidentiality will be guaranteed according to the provisions of Organic Law 03/2018, of December 5 and Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016 and data protection (RGPD). The data management plan generated by the project, all information will be stored and managed in a secure and confidential manner, in accordance with the provisions of Organic Law 03/2018. In order to scrupulously respect the current legislation, the following measures will be taken:
- Personal data will be pseudonymized. The identifying data are separated from the variables studied in the study. Therefore, a technical and functional separation will be made between the research team and those who perform the pseudonymization and retain the information that allows the reidentification of the participant. Pseudonymized data will only be accessible to the research team when: i) there is an express commitment to confidentiality and no re-identification activity, and ii) specific security measures are taken to prevent re-identification and access to unauthorized personal.
- The person receiving the informed consent and custody will be different from the person who will process the data, or if this is not possible, the entire research team will sign an express commitment of confidentiality not to carry out re-identification activities. The signed informed consents will be kept under lock and key and out of the reach of the research team in a generic sense.
- Conditions
- Schizophrenia, Schizophreniform Disorders, Delusional Disorder, Brief Psychotic Disorder, Schizoaffective Disorder, Schizophrenia Spectrum and Other Psychotic Disorders
- Being tested
- Cognitive Remediation (REHACOP), Metacognitive Training (MCT)
- Keywords
- Metacognitive Training, MCT, Cognitive Remediation, Psychotic disorder, Psychosis, Cognitive functions, Cognitive biases, Neurocognitive improvement
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation (REHACOP)Behavioural
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.
Metacognitive Training (MCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| REHACOP+MCT therapy | Experimental | The participants will receive a combined therapy: Metacognitive Training (MCT) with Cognitive Remediation (CR). Receives: Behavioral: Cognitive Remediation (REHACOP); Behavioral: Metacognitive Training (MCT) |
| MCT alone | Active comparator | The participants will receive Metacognitive Training (MCT) Receives: Behavioral: Metacognitive Training (MCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A sociodemographic and clinical questionnaire created by the investigators of this study will be given with the aim of collecting the following data: age, gender, education, civil status, coexistence, current professional situation, total number of psychotic episodes, age at the first episode, substance use, type of treatments received (past and present), duration of untreated psychosis (DUP), relapses, number of hospitalisations, diagnosis according to the DSM-5, referral centre, family history, grade of satisfaction with care received, among others.
Measured: 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
The facial emotion recognition test will be used (Baron-Cohen et al., 1997; Huerta-Ramos et al., 2017) constituted by 20 photographs expressing 10 basic and 10 complex emotions.
Measured: 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)
Includes different stories for evaluating the interpretation of social situations.
Measured: 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)
The IPSAQ has 32 items which describe 16 positive and 16 negative social situations. For each situation the person must decide whether the cause is internal, personal or situational.
Measured: 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).
Jumping to conclusions (JTC) will be evaluated with the ball task. This is a task of probabilities in which the persons have to make a decision as to which box a ball belongs. The task will be used with a probability of 85%-15%, 60%-40% and with emotional tasks. JTC will be considered as making a decision after the extraction of one or two balls (Dudley et al., 2016).
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013; Gutiérrez-Zotes, in press).
This questionnaire evaluates themost frequent cognitive biases in psychotic disorders. intentionality, catastrophism, dichotomic thinking, JTC and reasoning based on emotions.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004; Guitiérrez-Zotes et al., 2012).
This is a self applied questionnaire including 15 items which collect information on the capacity to correct erroneous judgements in two subscales: self-reflection and self-certainty.
Measured: 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 Functioning Scale (SFS) (Birchwood et al., 1990; Torres and Olivares, 2000).
This scale was designed with the aim of evaluating areas of social functioning that are crucial for persons with schizophrenia to remain in the community.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Cognitive functioning.
A battery of neuropsychological tests will be carried out to evaluate the domain of general cognitive functioning (Weschler Intelligence Scale [WAIS] (Weschler, 1999), to estimate the IQ using 4 subtests (vocabulary, similarities, block design and matrix reasoning), and specific domains of cognitive functioning.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Global Assessment Functioning (GAF) (Endicott et al., 1976).
This scale measures the general functioning of the patient on a scale from 0 to 100, with higher scores indicating better functioning. This scale can offer a score on clinical functioning (GAF-C) and another on social functioning (GAF-S).
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Positive and negative syndrome scale (PANSS) (Kay et al., 1987; Peralta and Cuesta, 1995).
The PANSS evaluates positive and negative symptoms and provides a score of general psychopathology.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993).
Attention
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964)
Learning and verbal memory
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948)
Executive functions
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Trail Making Test (TMT-B) (Reitan, 1993)
Executive functions
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Stroop Color and Word Test (Stroop, 1935)
Executive functions
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Trail Making Test (TMT-A) (Reintan, 1993)
Processing Speed
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976)
Processing Speed
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Letter-number sequencing (Wechsler Adult Intelligence Scale [WAIS]) (Weschler, 1999)
Processing Speed
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
The Stages of Recovery Instrument (STORI) (Andresen et al., 2006; Lemos et al., 2015)
Will be used to assess 4 components (search and maintain hope, reestablishment of positive identity, find the meaning of life and assume responsibility of one's own life) and 5 stages of the recovery process (moratorium, awareness, preparation, rebuilding and growth). This instrument is made up of 50 items which score in the Likert type scale from 0 to 5. The resulting scores represent the 5 phases of personal/psychological recovery. The scale showing the highest score indicates the stage of recovery in which the patient is at that time.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
WHO Quality of Life-BREF 26. (WHOQOL-BREF) (Üstun et al., 1988; Vázquez-Barquero et al., 2000).
Quality of life
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
World Health Organization Disability Assessment Schedule (WHO-DAS-II) (Üstun et al., 1988; Vázquez-Barquero et al., 2000)
It's an instrument designed to assess functioning and disability in six main domains: cognition, mobility, self-care, interpersonal relationships, activities of daily living, and participation in society.
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Internalized Stigma of Mental Illness Scale (ISMI) (Ritsher, Otilingama, Grajalesa, 2003)
Stigma
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Rosenberg self-esteem scale (RSES) (Rosenberg et al., 1965; Atienza, Balaguer & Moreno, 2000)
Self-esteem
Measured: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Consorci Sanitari de Terrassa, Hospital de Mataró, Centre d'Higiene Mental Les Corts, Fundació Els 3 Turons, Hospital San Carlos, Madrid, Andaluz Health Service, Institut d'Assistència Sanitària, Ministerio de Ciencia e Innovación, Spain, Hospital Son Espases, Parc Taulí Hospital Universitari, Servicio Cántabro de Salud
- Responsible party
- Principal investigator, Ana Barajas Velez, Universitat Autonoma de Barcelona
- Investigators
- Ana Barajas Velez, Principal investigator, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423651
- Sponsor's protocol ID
- PID2020-118907RA-I00
- Acronym
- CR+MCTp
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lamarca M, Navarro JB, Leon-Morales D, Gonzalez-Higueras F, Torres P, Cid J, Jorda-Jorda A, Birules I, Naides N, Vidal C, Garrido G, Crosas JM, Aznar A, Palma-Sevillano C, Sastre-Buades A, Sevilla-Llewellyn-Jones J, Vallina-Fernandez O, Gutierrez E, Calvo A, Group R, Ochoa S, Barajas A. Sex-specific predictors of self-stigma reduction in psychosis resulting from metacognitive interventions: Results from a randomized clinical trial. Womens Health (Lond). 2026 Jan-Dec;22:17455057261440689. doi: 10.1177/17455057261440689. Epub 2026 Jul 30.
PubMed 42531158
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Combining Metacognitive Training (MCT) With Cognitive Remediation (CR) in the Recovery of Patients With Psychotic Spectrum Disorders (CR+MCTp)
- ClinicalTrials.gov ID
- NCT06423651
- Acronym / sponsor ID
- CR+MCTp / PID2020-118907RA-I00
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Consorci Sanitari de Terrassa, Hospital de Mataró, Centre d'Higiene Mental Les Corts, Fundació Els 3 Turons, Hospital San Carlos, Madrid, Andaluz Health Service, Institut d'Assistència Sanitària, Ministerio de Ciencia e Innovación, Spain, Hospital Son Espases, Parc Taulí Hospital Universitari, Servicio Cántabro de Salud
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project is aimed at responding to one of the Challenges of the Spanish Strategy for Science, Technology and Innovation, specifically Challenge 1: Health, demographic change and well-being. One of the work areas that are located within this challenge is the Clinical and Translational Research based on the evidence of scientific and technological knowledge.The present proposal is clearly within the framework of clinical-translational investigation, since most of the entities participating attend persons with psychotic disorders, thereby ensuring the translation of investigation to the clinical setting. In addition, this project includes investigators with wide experience in psychological interventions in the target population and with previous experience in investigation in this area. Lastly, it is of note that the benefits of this investigation are not only of a scientific nature but also involve clinical investigation with a direct repercussion on improvement in the health care of people with psychotic disorders, enabling the design of new strategies of psychological interventions. Besides, the present proposal is aimed at responding to the challenges of our society, contributing to covering the needs of persons with psychotic disorder as well as developing the most effective therapeutic strategies to improve aspects related to clinical and personal recovery. Specifically, this project will allow making changes that will improve the quality of health care to the target population incorporating the combinated use of scientifically proven therapeutic strategies to health care services. In short, this project aims to promote innovation in the provision of mental health services, being the starting point in analyzing the efficacy of combined psychological therapies versus monotherapies address to improve of metacognitive processes.
- General and specific objectives. General objective: Compare the efficacy of combined REHACOP + MCT therapy vs. MCT alone in persons with nonaffective psychotic disorder in terms of recovery.
Specific objectives:
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery (clinical remission and functional recovery, the latter understood in terms of cognitive, occupational and social functioning).
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on personal/psychological recovery.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on cognitive biases and social cognition.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to gender.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to self-esteem, quality of life and stigma.
- Evaluate the maintenance of the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery, personal recovery, cognitive biases and social cognition in the long term.
- Methodology
Design:
This will be a randomised 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 subjects: The sample will be made up of people with non-affective psychotic disorder who are attended in any of the centres participating in the study which belong to the following entities:Consorci Sanitari de Terrassa; Hospital de Mataró; Instituto de Investigación Biomédica de Gerona (IdIBG); Parc Sanitari Sant Joan de Déu; Asociación Centro de Higiene Mental Les Corts; Hospital Sierrallana-Tres Mares; and UGC Salud Mental de Jaén.
Sample size: Considering that the investigators have no preliminary data on our principal objective in relation to clinical and personal recovery, the score obtained in the global assessment of functioning (GAF) at follow-up will be taken as a measure of outcome, since it is implicated in both clinical and functional recovery. The investigators used the data published in the article by Ochoa et al. (2017) in order to calculate the required sample size for this study. In this article, a difference of means of 5.73 points (SD=11.51) is obtained in the GAF scale from baseline and the follow-up at 6 months after the intervention. With these data, the necessary sample size has been estimated with an alpha of 0.05 and a power of 0.8. Taking into account 20% of possible losses to follow-up, the sample size has been calculated as 160 cases, 80 in each experimental arm (REHACOP + MCT vs. MCT). In this way, taking into account that the intervention groups will be carried out in the health care centers of 7 different entities each will have to recruit 24 patients, 12 for each experimental condition.
Data collection: the professional who makes the referral of the patients to the study will be responsible for reviewing fulfillment of the inclusion and exclusion criteria. Patients fulfilling the inclusion criteria will receive an explanation of the study and if they accept to participate, they must provide signed informed consent. The evaluation will be carried out at 3 time points: T0 (basal assessment, prior to initiation of treatment). All the previously described scales will be administered; T1 (post-treatment evaluation), all the scales will be administered and, in addition, the satisfaction perceived with the interventions received will be evaluated; T2 (follow-up evaluation ) at 6 months after completing the intervention all the scales will again be administered. In addition, the number of relapses and hospitalizations during the time interval will be registered. Assessment of the PANSS and GAF should take into account the temporal criterium mentioned in the section of 'Outcomes'. A contingency plan will be considered in the event that difficulties are detected in carrying out any of the phases of the study due to external causes, such as the continuity of the COVID-19 pandemic. This plan will consist of the implementation of interventions and evaluations making use of new technologies. All the centers already have the adequate infrastructure to carry out the project under these conditions.
Data analysis: Firstly, the two groups will be compared with the aim of verifying that there are no significant differences at baseline to confirm that they are comparable after randomization. Comparisons of means for independent samples will be carried out using the Student's t-test for continuous variables and the Chi-square test for categorical variables. The variables of the principal analysis will be the difference between the scores of the two groups (REHACOP+MCT and MCT) in the scores of the scales assessing clinical and personal/psychological recovery. The secondary results will be the differences in other assessments of social functioning, cognitive biases, and social cognition on comparing the two experimental conditions. Changes in the scores of these scales will be analyzed using regression methods for repeated measures, with the post-treatment score of the scales as the dependent variable and the basal score and the REHACOP+MCT group as the co-variables. Temporal stability of the results at 6 months will be assessed using the follow-up score as the dependent variable and evaluating how this affects the basal score, post treatment and the experimental condition. The statistical analyses will be performed according to intention to treat (ITT) without imputing the lost values. Gender, antipsychotic medication, and disease evolution time will be considered as control variables.
Limitations:
One of the limitations of this clinical trial might be the loss to follow-up. To compensate for these losses the sample size will be increased by 20%. It is expected that the losses to follow-up will be similar in the two groups. Otherwise, this variable will be considered as an indicator of the acceptability of treatment.
- Ethical considerations: All the people who participate in the trial will sign the informed consent that takes into account the Declaration of Helsinki and the Organic Law 03/2018 of December 5. In the cases of minors informed consent will be signed by the legal guardians The project will be evaluated by each of the Ethics Committees of the participating centers.
Participants will be informed that the data obtained will only be used for purposes related to the investigation and data confidentiality will be guaranteed according to the provisions of Organic Law 03/2018, of December 5 and Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016 and data protection (RGPD). The data management plan generated by the project, all information will be stored and managed in a secure and confidential manner, in accordance with the provisions of Organic Law 03/2018. In order to scrupulously respect the current legislation, the following measures will be taken:
- Personal data will be pseudonymized. The identifying data are separated from the variables studied in the study. Therefore, a technical and functional separation will be made between the research team and those who perform the pseudonymization and retain the information that allows the reidentification of the participant. Pseudonymized data will only be accessible to the research team when: i) there is an express commitment to confidentiality and no re-identification activity, and ii) specific security measures are taken to prevent re-identification and access to unauthorized personal.
- The person receiving the informed consent and custody will be different from the person who will process the data, or if this is not possible, the entire research team will sign an express commitment of confidentiality not to carry out re-identification activities. The signed informed consents will be kept under lock and key and out of the reach of the research team in a generic sense.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| REHACOP+MCT therapy | Experimental | Behavioral: Cognitive Remediation (REHACOP), Behavioral: Metacognitive Training (MCT)The participants will receive a combined therapy: Metacognitive Training (MCT) with Cognitive Remediation (CR). |
| MCT alone | Active comparator | Behavioral: Metacognitive Training (MCT)The participants will receive Metacognitive Training (MCT) |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | REHACOP+MCT therapy |
| 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. | Behavioural | MCT alone, REHACOP+MCT therapy |
Primary outcome
CLINICAL RECOVERY
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
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.
FUNCTIONAL RECOVERY
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
To be measured with the STORI test.
24 secondary outcomes
Assesment instruments
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013; Gutiérrez-Zotes, in press).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004; Guitiérrez-Zotes et al., 2012).
Time frame: 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 Functioning Scale (SFS) (Birchwood et al., 1990; Torres and Olivares, 2000).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Cognitive functioning.
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Global Assessment Functioning (GAF) (Endicott et al., 1976).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Positive and negative syndrome scale (PANSS) (Kay et al., 1987; Peralta and Cuesta, 1995).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Trail Making Test (TMT-B) (Reitan, 1993)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Stroop Color and Word Test (Stroop, 1935)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Trail Making Test (TMT-A) (Reintan, 1993)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Letter-number sequencing (Wechsler Adult Intelligence Scale [WAIS]) (Weschler, 1999)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
The Stages of Recovery Instrument (STORI) (Andresen et al., 2006; Lemos et al., 2015)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
WHO Quality of Life-BREF 26. (WHOQOL-BREF) (Üstun et al., 1988; Vázquez-Barquero et al., 2000).
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
World Health Organization Disability Assessment Schedule (WHO-DAS-II) (Üstun et al., 1988; Vázquez-Barquero et al., 2000)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Internalized Stigma of Mental Illness Scale (ISMI) (Ritsher, Otilingama, Grajalesa, 2003)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Rosenberg self-esteem scale (RSES) (Rosenberg et al., 1965; Atienza, Balaguer & Moreno, 2000)
Time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 42531158Lamarca M, Navarro JB, Leon-Morales D, Gonzalez-Higueras F, Torres P, Cid J, Jorda-Jorda A, Birules I, Naides N, Vidal C, Garrido G, Crosas JM, Aznar A, Palma-Sevillano C, Sastre-Buades A, Sevilla-Llewellyn-Jones J, Vallina-Fernandez O, Gutierrez E, Calvo A, Group R, Ochoa S, Barajas A. Sex-specific predictors of self-stigma reduction in psychosis resulting from metacognitive interventions: Results from a randomized clinical trial. Womens Health (Lond). 2026 Jan-Dec;22:17455057261440689. doi: 10.1177/17455057261440689. Epub 2026 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Barajas Velez principal investigator
Universitat Autonoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation (REHACOP) and Metacognitive Training (MCT) in people with Schizophrenia and Schizophreniform Disorders, run by Universitat Autonoma de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Barajas Velez (+34935814452, ana.barajas@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL RECOVERY (time frame: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.