Clinical trial NCT05358457: Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
Official title: Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychosis
Mother-Child Relations
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Hospital de Sant Pau
name: Institut Pere Mata
name: Parc Taulí Hospital Universitari
name: Hospital de Mataró
name: Centre d'Higiene Mental Les Corts
name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Hospital del Mar
name: Hospital Universitario Marqués de Valdecilla
name: Hospitales Universitarios Virgen del Rocío
name: Fundació Vidal i Barraquer
name: Hospital Sant Joan de Deu
First posted: 2022-05-03
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parrallel Assigment. This is a randomized clinical trial in which some patients receive the MCTf intervention and others treatment as usual
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: baseline
measure: BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
timeFrame: up to 11 weeks
Secondary outcomes:
measure: CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
timeFrame: baseline
measure: CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
timeFrame: up to 11 weeks
measure: Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
timeFrame: baseline
measure: Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
timeFrame: up to 11 weeks
measure: IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
timeFrame: baseline
measure: IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
timeFrame: up to 11 weeks
measure: The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
timeFrame: baseline
measure: The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
timeFrame: up to 11 weeks
measure: Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
timeFrame: baseline
measure: Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
timeFrame: after the intervention
measure: SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
timeFrame: baseline
measure: SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
timeFrame: up to 11 weeks
measure: FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
timeFrame: baseline
measure: FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
timeFrame: up to 11 weeks
measure: SWLS Satisfaction with life style (Pons et al., 2002)
timeFrame: baseline
measure: SWLS Satisfaction with life style (Pons et al., 2002)
timeFrame: up to 11 weeks
measure: PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
timeFrame: baseline
measure: PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
timeFrame: up to 11 weeks
measure: CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
timeFrame: baseline
measure: CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
timeFrame: up to 11 weeks
measure: SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
timeFrame: baseline
measure: SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
timeFrame: up to 11 weeks
measure: EEAG-Scale of Functioning (Endicot et al., 1976)
timeFrame: baseline
measure: EEAG-Scale of Functioning (Endicot et al., 1976)
timeFrame: up to 11 weeks
measure: Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
timeFrame: baseline
measure: Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
timeFrame: up to 11 weeks
measure: CD Risk 17 (Serrano et al., 2013)
timeFrame: baseline
measure: Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
timeFrame: baseline
measure: Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
timeFrame: up to 11 weeks
measure: SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
timeFrame: baseline
measure: SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
timeFrame: up to 11 weeks
measure: PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)
timeFrame: baseline
measure: CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)
timeFrame: baseline
measure: YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
timeFrame: baseline
measure: YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
timeFrame: up to 11 weeks
measure: KASI The Knowledge About Schizophrenia Interview
timeFrame: baseline
measure: KASI The Knowledge About Schizophrenia Interview
timeFrame: up to 11 weeks
Other outcomes:
measure: WAIS-IV (Weschler Adults Intelligence Scale, 1955)
timeFrame: baseline
measure: TMT-A Trail Making Test, Retain, 1993
timeFrame: baseline
measure: TMT-A Trail Making Test, Retain, 1993
timeFrame: up to 11 weeks
measure: TMT-B Trail Making Test, Retain, 1993
timeFrame: baseline
measure: TMT-B Trail Making Test, Retain, 1993
timeFrame: up to 11 weeks
measure: WAIS-IV (Weschler Adults Intelligence Scale, 1955)
timeFrame: baseline
measure: WAIS-IV (Weschler Adults Intelligence Scale, 1955)
timeFrame: up to 11 weeks
Locations:
Study officials:
affiliation: Parc Sanitari Sant Joan de Deu
name: Susana Ochoa, Phd
role: PRINCIPAL_INVESTIGATOR
References: