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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05358457
Other study ID # PI21/00012
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date December 2025

Study information

Verified date April 2022
Source Fundació Sant Joan de Déu
Contact Susana Ochoa, Phd
Phone 936406350
Email susana.ochoa@sjd.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - 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. - Mother of one o more adolescent (12-18 years old). - Psychopatological stability in the previous 3 months.(without medication changes). Exclusion Criteria: - Head injury or intellectual disabillity (premorbid IQ <=70) - Present scores on the PANSS >= hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group. - Patients with substance dependence disorder. Inclusion/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).

Study Design


Intervention

Behavioral:
Familiar Metacognitive Training
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.

Locations

Country Name City State
n/a

Sponsors (13)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu Centre d'Higiene Mental Les Corts, Fundació Vidal i Barraquer, Hospital de Mataró, Hospital de Sant Pau, Hospital del Mar, Hospital Parc Taulí, Sabadell, Hospital Sant Joan de Deu, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío, Institut Pere Mata, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Parc Sanitari Sant Joan de Déu

Outcome

Type Measure Description Time frame Safety issue
Other WAIS-IV (Weschler Adults Intelligence Scale, 1955) vocabulary subscale to explore premorbid IQ baseline
Other TMT-A Trail Making Test, Retain, 1993 Visual attention and task switching. Higher values represent a worse outcome. baseline
Other TMT-A Trail Making Test, Retain, 1993 Visual attention and task switching. Higher values represent a worse outcome. up to 11 weeks
Other TMT-B Trail Making Test, Retain, 1993 Visual attention and task switching. Higher values represent a worse outcome. baseline
Other TMT-B Trail Making Test, Retain, 1993 Visual attention and task switching. Higher values represent a worse outcome. up to 11 weeks
Other WAIS-IV (Weschler Adults Intelligence Scale, 1955) Digits subscale. Higher values represent a better outcome. baseline
Other WAIS-IV (Weschler Adults Intelligence Scale, 1955) Digits subscale. Higher values represent a better outcome. up to 11 weeks
Primary BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012) 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. baseline
Primary BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012) 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. up to 11 weeks
Secondary CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021 Scale for the assessment of the most cognitive biases in psychosis.Higher values represent more biases. baseline
Secondary CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021 Scale for the assessment of the most cognitive biases in psychosis. Higher values represent more biases. up to 11 weeks
Secondary Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997) 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. baseline
Secondary Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997) 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. up to 11 weeks
Secondary IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006) The scale assess the attributional style in different situations.There are no ranges. baseline
Secondary IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006) The scale assess the attributional style in different situations.There are no ranges. up to 11 weeks
Secondary The Hinting Task (Corcoran et al., 1995; Gil et al., 2012) The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome. baseline
Secondary The Hinting Task (Corcoran et al., 1995; Gil et al., 2012) The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome. up to 11 weeks
Secondary Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021) 20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome. baseline
Secondary Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021) 20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome. after the intervention
Secondary SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018) The scales assess social perception. There are no ranges baseline
Secondary SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018) The scales assess social perception. There are no ranges up to 11 weeks
Secondary FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995) The scale include 3 dimensions: relationships, development and stability. baseline
Secondary FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995) The scale include 3 dimensions: relationships, development and stability. up to 11 weeks
Secondary SWLS Satisfaction with life style (Pons et al., 2002) The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered. baseline
Secondary SWLS Satisfaction with life style (Pons et al., 2002) The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered. up to 11 weeks
Secondary PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994) This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology baseline
Secondary PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994) This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology up to 11 weeks
Secondary CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990) The scale assess affective symptoms. Higher values indicate more symptoms. baseline
Secondary CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990) The scale assess affective symptoms. Higher values indicate more symptoms. up to 11 weeks
Secondary SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008) The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision baseline
Secondary SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008) The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision up to 11 weeks
Secondary EEAG-Scale of Functioning (Endicot et al., 1976) This scale measures the general functioning of the patient on a scale that ranges from 0 to 100. baseline
Secondary EEAG-Scale of Functioning (Endicot et al., 1976) This scale measures the general functioning of the patient on a scale that ranges from 0 to 100. up to 11 weeks
Secondary Rosenberg Self-Esteem Scale (Martín Albó et al., 2007) Questionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items. baseline
Secondary Rosenberg Self-Esteem Scale (Martín Albó et al., 2007) Questionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items. up to 11 weeks
Secondary CD Risk 17 (Serrano et al., 2013) The scale assess resilience with a total of 17 items. baseline
Secondary Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007) The scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy. baseline
Secondary Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007) The scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy. up to 11 weeks
Secondary SSQ Self Stigma Questionnaire (Ochoa et al.,2015) The scales assess self-stigma. It consists of 14 items and is self-administered baseline
Secondary SSQ Self Stigma Questionnaire (Ochoa et al.,2015) The scales assess self-stigma. It consists of 14 items and is self-administered up to 11 weeks
Secondary PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013) The scale assess attachment styles baseline
Secondary CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012) The self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect. baseline
Secondary YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002) It is an instrument to assess symptoms in adolescents between 11 and 18 years old. baseline
Secondary YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002) It is an instrument to assess symptoms in adolescents between 11 and 18 years old. up to 11 weeks
Secondary KASI The Knowledge About Schizophrenia Interview Scale to asses the beliefs of the disorder baseline
Secondary KASI The Knowledge About Schizophrenia Interview Scale to asses the beliefs of the disorder up to 11 weeks
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