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Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)

Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05358457
Acronym
MCTf
Enrollment
48
Registered
2022-05-03
Start date
2022-09-30
Completion date
2025-12-31
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-Child Relations, Psychosis

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.

Interventions

BEHAVIORALFamiliar 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluator will be blind to the group that ows the patients included

Intervention model description

Parrallel Assigment. This is a randomized clinical trial in which some patients receive the MCTf intervention and others treatment as usual

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)baselineThis 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.

Secondary

MeasureTime frameDescription
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)baselineThe scale assess affective symptoms. Higher values indicate more symptoms.
CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)baselineThe self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect.
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)baselineIt is an instrument to assess symptoms in adolescents between 11 and 18 years old.
KASI The Knowledge About Schizophrenia InterviewbaselineScale to asses the beliefs of the disorder
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021baselineScale for the assessment of the most cognitive biases in psychosis.Higher values represent more biases.
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)baselineScale 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.
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)baselineThe scale assess the attributional style in different situations.There are no ranges.
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)baselineThe scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)baseline20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)baselineThe scales assess social perception. There are no ranges
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)baselineThe scale include 3 dimensions: relationships, development and stability.
SWLS Satisfaction with life style (Pons et al., 2002)baselineThe scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)baselineThis scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)baselineThe scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision
EEAG-Scale of Functioning (Endicot et al., 1976)baselineThis scale measures the general functioning of the patient on a scale that ranges from 0 to 100.
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)baselineQuestionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items.
CD Risk 17 (Serrano et al., 2013)baselineThe scale assess resilience with a total of 17 items.
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)baselineThe scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy.
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)baselineThe scales assess self-stigma. It consists of 14 items and is self-administered
PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)baselineThe scale assess attachment styles

Other

MeasureTime frameDescription
TMT-B Trail Making Test, Retain, 1993baselineVisual attention and task switching. Higher values represent a worse outcome.
TMT-A Trail Making Test, Retain, 1993baselineVisual attention and task switching. Higher values represent a worse outcome.
WAIS-IV (Weschler Adults Intelligence Scale, 1955)baselinevocabulary subscale to explore premorbid IQ

Contacts

Primary ContactSusana Ochoa, Phd
susana.ochoa@sjd.es936406350
Backup ContactRaquel Lopez, Msc
raquel.lopezc@sjd.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026