Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-02 @ 3:01 AM
Study NCT ID:
NCT05358457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-03
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The evaluator will be blind to the group that ows the patients included'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parrallel Assigment. This is a randomized clinical trial in which some patients receive the MCTf intervention and others treatment as usual'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'WAIS-IV (Weschler Adults Intelligence Scale, 1955)', 'timeFrame': 'baseline', 'description': 'vocabulary subscale to explore premorbid IQ'}, {'measure': 'TMT-A Trail Making Test, Retain, 1993', 'timeFrame': 'baseline', 'description': 'Visual attention and task switching. Higher values represent a worse outcome.'}, {'measure': 'TMT-A Trail Making Test, Retain, 1993', 'timeFrame': 'up to 11 weeks', 'description': 'Visual attention and task switching. Higher values represent a worse outcome.'}, {'measure': 'TMT-B Trail Making Test, Retain, 1993', 'timeFrame': 'baseline', 'description': 'Visual attention and task switching. Higher values represent a worse outcome.'}, {'measure': 'TMT-B Trail Making Test, Retain, 1993', 'timeFrame': 'up to 11 weeks', 'description': 'Visual attention and task switching. Higher values represent a worse outcome.'}, {'measure': 'WAIS-IV (Weschler Adults Intelligence Scale, 1955)', 'timeFrame': 'baseline', 'description': 'Digits subscale. Higher values represent a better outcome.'}, {'measure': 'WAIS-IV (Weschler Adults Intelligence Scale, 1955)', 'timeFrame': 'up to 11 weeks', 'description': 'Digits subscale. Higher values represent a better outcome.'}], 'primaryOutcomes': [{'measure': 'BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)', 'timeFrame': 'baseline', 'description': 'This scales is a self-registering measure of 15 items. It has 2 dimensions:self-reflection and self-certaintly. A compound index of cognitive insight is obtained as the substraction of self-certaintly from self-reflection.Range 0-45. Higher values represent a better outcome.'}, {'measure': 'BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)', 'timeFrame': 'up to 11 weeks', 'description': 'This scales is a self-registering measure of 15 items. It has 2 dimensions:self-reflection and self-certaintly. A compound index of cognitive insight is obtained as the substraction of self-certaintly from self-reflection.Range 0-45. Higher values represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021', 'timeFrame': 'baseline', 'description': 'Scale for the assessment of the most cognitive biases in psychosis.Higher values represent more biases.'}, {'measure': 'CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021', 'timeFrame': 'up to 11 weeks', 'description': 'Scale for the assessment of the most cognitive biases in psychosis. Higher values represent more biases.'}, {'measure': 'Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)', 'timeFrame': 'baseline', 'description': 'Scale for the assessment to the Jumping to conclusions bias. 3 tasks will be included. JTC is considered if the decision is taken before the third ball.'}, {'measure': 'Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)', 'timeFrame': 'up to 11 weeks', 'description': 'Scale for the assessment to the Jumping to conclusions bias. 3 tasks will be included. JTC is considered if the decision is taken before the third ball.'}, {'measure': 'IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)', 'timeFrame': 'baseline', 'description': 'The scale assess the attributional style in different situations.There are no ranges.'}, {'measure': 'IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale assess the attributional style in different situations.There are no ranges.'}, {'measure': 'The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)', 'timeFrame': 'baseline', 'description': 'The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.'}, {'measure': 'The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.'}, {'measure': 'Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)', 'timeFrame': 'baseline', 'description': '20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.'}, {'measure': 'Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)', 'timeFrame': 'after the intervention', 'description': '20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.'}, {'measure': 'SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)', 'timeFrame': 'baseline', 'description': 'The scales assess social perception. There are no ranges'}, {'measure': 'SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)', 'timeFrame': 'up to 11 weeks', 'description': 'The scales assess social perception. There are no ranges'}, {'measure': 'FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)', 'timeFrame': 'baseline', 'description': 'The scale include 3 dimensions: relationships, development and stability.'}, {'measure': 'FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale include 3 dimensions: relationships, development and stability.'}, {'measure': 'SWLS Satisfaction with life style (Pons et al., 2002)', 'timeFrame': 'baseline', 'description': 'The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.'}, {'measure': 'SWLS Satisfaction with life style (Pons et al., 2002)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.'}, {'measure': 'PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)', 'timeFrame': 'baseline', 'description': 'This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology'}, {'measure': 'PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)', 'timeFrame': 'up to 11 weeks', 'description': 'This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology'}, {'measure': 'CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)', 'timeFrame': 'baseline', 'description': 'The scale assess affective symptoms. Higher values indicate more symptoms.'}, {'measure': 'CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale assess affective symptoms. Higher values indicate more symptoms.'}, {'measure': 'SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)', 'timeFrame': 'baseline', 'description': 'The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision'}, {'measure': 'SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision'}, {'measure': 'EEAG-Scale of Functioning (Endicot et al., 1976)', 'timeFrame': 'baseline', 'description': 'This scale measures the general functioning of the patient on a scale that ranges from 0 to 100.'}, {'measure': 'EEAG-Scale of Functioning (Endicot et al., 1976)', 'timeFrame': 'up to 11 weeks', 'description': 'This scale measures the general functioning of the patient on a scale that ranges from 0 to 100.'}, {'measure': 'Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)', 'timeFrame': 'baseline', 'description': 'Questionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items.'}, {'measure': 'Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)', 'timeFrame': 'up to 11 weeks', 'description': 'Questionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items.'}, {'measure': 'CD Risk 17 (Serrano et al., 2013)', 'timeFrame': 'baseline', 'description': 'The scale assess resilience with a total of 17 items.'}, {'measure': 'Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)', 'timeFrame': 'baseline', 'description': 'The scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy.'}, {'measure': 'Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)', 'timeFrame': 'up to 11 weeks', 'description': 'The scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy.'}, {'measure': 'SSQ Self Stigma Questionnaire (Ochoa et al.,2015)', 'timeFrame': 'baseline', 'description': 'The scales assess self-stigma. It consists of 14 items and is self-administered'}, {'measure': 'SSQ Self Stigma Questionnaire (Ochoa et al.,2015)', 'timeFrame': 'up to 11 weeks', 'description': 'The scales assess self-stigma. It consists of 14 items and is self-administered'}, {'measure': 'PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)', 'timeFrame': 'baseline', 'description': 'The scale assess attachment styles'}, {'measure': 'CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)', 'timeFrame': 'baseline', 'description': 'The self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect.'}, {'measure': 'YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)', 'timeFrame': 'baseline', 'description': 'It is an instrument to assess symptoms in adolescents between 11 and 18 years old.'}, {'measure': 'YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)', 'timeFrame': 'up to 11 weeks', 'description': 'It is an instrument to assess symptoms in adolescents between 11 and 18 years old.'}, {'measure': 'KASI The Knowledge About Schizophrenia Interview', 'timeFrame': 'baseline', 'description': 'Scale to asses the beliefs of the disorder'}, {'measure': 'KASI The Knowledge About Schizophrenia Interview', 'timeFrame': 'up to 11 weeks', 'description': 'Scale to asses the beliefs of the disorder'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychosis', 'Mother-Child Relations']}, 'referencesModule': {'references': [{'pmid': '38586292', 'type': 'DERIVED', 'citation': 'Ochoa S, Espinosa V, Lopez-Carrilero R, Martinez I, Barrera AH, Birules I, Barajas A, Pelaez T, Diaz-Cutraro L, Coromina M, Gonzalez-Rodriguez A, Verdaguer-Rodriguez M, Gutierrez-Zotes A, Palma-Sevillano C, Montes C, Gallego J, Paya B, Casanovas F, Roldan M, Noval E, Varela Casals P, Salas-Sender M, Aznar A, Ayesa-Arriola R, Pousa E, Canal-Rivero M, Garrido-Torres N, Montserrat C, Munoz-Lorenzo L, Crosas JM. Effectiveness of family metacognitive training in mothers with psychosis and their adolescent children: a multicenter study protocol. Front Psychol. 2024 Mar 22;15:1359693. doi: 10.3389/fpsyg.2024.1359693. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to adapt and evaluate the efficacy of Familiar Metacognitive Training (MCTf) in mothers and adolescent children in a group context with the main purpose of improving family relationships, cognitive awareness and symptoms of women with psychosis and the knowledge of the disease by the children. Secondary objectives: to evaluate the improvement in metacognition and social cognition, symptoms, protective factors and self-perception of stigma.', 'detailedDescription': 'This is a randomized clinical trial will be carried out in which a group of mothers with psychosis and their adolescent children (between 12 and 18 years old) will receive the MCTf online and the other group will receive the treatment as usual. In total, 48 mothers and their children will be recruited from a total of 11 adult mental health care centers. Mothers will be evaluated with cognitive insight scales, other metacognitive and social cognition scales, symptoms, family and social functioning, protective factors (self-steem, resilience, and coping strategies) and self-perceived stigma. The adolescent children will be evaluated with symptoms, metacognition and social cognition, family and social functioning, knowledge of the mother´s illness and protective factors scales. The will be assessed at 2 times: baseline and post-therapy. The Metacognitive training is a group psychological intervention that has demonstrated its efficacy in improve symptoms, insight, metacognition and cognition in people with psychosis. Our hypothesis is that MCTf will be help the adolescents to better understand their mother´s thoughts and their understanding of metacognition and, consequently, to decrease anxiety and depressive symptoms.Furthermore, the investigators expect an increase in familiar and social functioning, as well as in protective factors such as: self-steem, resilience and coping strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.\n* Mother of one o more adolescent (12-18 years old).\n* Psychopatological stability in the previous 3 months.(without medication changes).\n\nExclusion Criteria:\n\n* Head injury or intellectual disabillity (premorbid IQ \\<=70)\n* Present scores on the PANSS \\>= hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group.\n* Patients with substance dependence disorder.\n\nInclusion/exclusion criteria of adolescents are: 1.age between 12 and 18 yerars old, 2. interested in the group. Exclusion criteria: Head injury or intellectual disabillity (premorbid IQ \\<=70).'}, 'identificationModule': {'nctId': 'NCT05358457', 'acronym': 'MCTf', 'briefTitle': 'Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Sant Joan de Déu'}, 'officialTitle': 'Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children', 'orgStudyIdInfo': {'id': 'PI21/00012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online Familiar Metacognitive Training', 'description': 'Metacognitive training for psychosis. The MCTf consists of 11 therapeutic units developed during weekly sessions lasting 45 and 60 minutes. Each unit contains abundant therapeutic material that includes psychoeducational information, exercises and case examples.The group will be composed of 3-4 mothers with psychosis and her adolescent children and two therapists. The application of the intervention will be by a secure videoconfering method.', 'interventionNames': ['Behavioral: Familiar Metacognitive Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will be receive treatment as usual (TAU).'}], 'interventions': [{'name': 'Familiar Metacognitive Training', 'type': 'BEHAVIORAL', 'description': 'The original metacognitive training program consist of 8 therapeutic units and 2 complementary. Seven of the therapeutic units address cognitive deviations and errors that are frequently seen in problem solving in schizophrenia, involved in the formation and maintenance of delusions. The other three units work with metacognition and the aims of the progra, as a psychoeducation session, so in total the MCTf will include 11 sessions.', 'armGroupLabels': ['Online Familiar Metacognitive Training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Susana Ochoa, Phd', 'role': 'CONTACT', 'email': 'susana.ochoa@sjd.es', 'phone': '936406350', 'phoneExt': '12538'}, {'name': 'Raquel Lopez, Msc', 'role': 'CONTACT', 'email': 'raquel.lopezc@sjd.es'}], 'overallOfficials': [{'name': 'Susana Ochoa, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parc Sanitari Sant Joan de Deu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Sant Joan de Déu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Parc Sanitari Sant Joan de Déu', 'class': 'OTHER'}, {'name': 'Hospital de Sant Pau', 'class': 'OTHER'}, {'name': 'Institut Pere Mata', 'class': 'UNKNOWN'}, {'name': 'Parc Taulí Hospital Universitari', 'class': 'OTHER'}, {'name': 'Hospital de Mataró', 'class': 'OTHER'}, {'name': "Centre d'Higiene Mental Les Corts", 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital Universitario Marqués de Valdecilla', 'class': 'OTHER'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Fundació Vidal i Barraquer', 'class': 'UNKNOWN'}, {'name': 'Hospital Sant Joan de Deu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}