Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders
NCT06423651, Not applicable, Unknown, Universitat Autonoma de Barcelona
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Benefits of Combining MCT With CR in the Recovery of Patients With Psychotic Spectrum Disorders | ClinicalTrials.gov |
| NCT number | NCT06423651 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universitat Autonoma de Barcelona | ClinicalTrials.gov |
| Conditions | Schizophrenia, Schizophreniform Disorders, Delusional Disorder, Brief Psychotic Disorder, Schizoaffective Disorder, Schizophrenia Spectrum and Other Psychotic Disorders | ClinicalTrials.gov |
| Interventions | Cognitive Remediation (REHACOP), Metacognitive Training (MCT) | ClinicalTrials.gov |
| First posted | 2024-05-21 | ClinicalTrials.gov |
| Last updated | 2024-05-23 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | CLINICAL RECOVERY | 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. | ClinicalTrials.gov |
| Primary | FUNCTIONAL RECOVERY | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | Includes different stories for evaluating the interpretation of social situations. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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). | ClinicalTrials.gov |
| Secondary | Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013; Gutiérrez-Zotes, in press). | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | This questionnaire evaluates themost frequent cognitive biases in psychotic disorders. intentionality, catastrophism, dichotomic thinking, JTC and reasoning based on emotions. | ClinicalTrials.gov |
| Secondary | Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004; Guitiérrez-Zotes 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. | 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. | ClinicalTrials.gov |
| Secondary | Social Functioning Scale (SFS) (Birchwood et al., 1990; Torres and Olivares, 2000). | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | Global Assessment Functioning (GAF) (Endicott et al., 1976). | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | 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). | ClinicalTrials.gov |
| Secondary | Positive and negative syndrome scale (PANSS) (Kay et al., 1987; Peralta and Cuesta, 1995). | 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 PANSS evaluates positive and negative symptoms and provides a score of general psychopathology. | ClinicalTrials.gov |
| Secondary | Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993). | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Attention | ClinicalTrials.gov |
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Learning and verbal memory | ClinicalTrials.gov |
| Secondary | Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Executive functions | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT-B) (Reitan, 1993) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Executive functions | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test (Stroop, 1935) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Executive functions | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT-A) (Reintan, 1993) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Processing Speed | ClinicalTrials.gov |
| Secondary | Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976) | It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention. | Processing Speed | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42531158 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 11
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Emoji Emotion Recognition | Secondary outcome | ConductCognition |
| Indirect Hints Task | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)