Schizophrenia Clinical Trial
— CR+MCTpOfficial 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? 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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universitat Autonoma de Barcelona | Cerdanyola Del Vallès | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Autonoma de Barcelona | Andaluz Health Service, Centre d'Higiene Mental Les Corts, Consorci Sanitari de Terrassa, Fundació Els 3 Turons, Hospital de Mataró, Hospital San Carlos, Madrid, Hospital Son Espases, Institut d'Assistència Sanitària, Ministerio de Ciencia, Innovación y Universidades, Parc Sanitari Sant Joan de Déu, Parc Taulí Hospital Universitari, Servicio Cántabro de Salud |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | 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 | 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. | 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 | Social Cognition. Hinting Task (Corcoran et al., 1995; Gil et al., 2012) | Includes different stories for evaluating the interpretation of social situations. | 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 | 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. | 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 | 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). | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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). | 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 | 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. | 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 | Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993). | Attention | 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 | Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964) | Learning and verbal memory | 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 | Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948) | Executive functions | 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 | Trail Making Test (TMT-B) (Reitan, 1993) | Executive functions | 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 | Stroop Color and Word Test (Stroop, 1935) | Executive functions | 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 | Trail Making Test (TMT-A) (Reintan, 1993) | Processing Speed | 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 | Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976) | Processing Speed | 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 | Letter-number sequencing (Wechsler Adult Intelligence Scale [WAIS]) (Weschler, 1999) | Processing Speed | 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 | 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. | 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 | WHO Quality of Life-BREF 26. (WHOQOL-BREF) (Üstun et al., 1988; Vázquez-Barquero et al., 2000). | Quality of life | 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 | 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. | 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 | Internalized Stigma of Mental Illness Scale (ISMI) (Ritsher, Otilingama, Grajalesa, 2003) | Stigma | 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 | Rosenberg self-esteem scale (RSES) (Rosenberg et al., 1965; Atienza, Balaguer & Moreno, 2000) | Self-esteem | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. |
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