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

NCT ID: NCT05358457

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Psychosis Mother-Child Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Online Familiar Metacognitive Training

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.

Group Type EXPERIMENTAL

Familiar Metacognitive Training

Intervention Type BEHAVIORAL

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.

Control group

The control group will be receive treatment as usual (TAU).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Parc Sanitari Sant Joan de Déu

OTHER

Sponsor Role collaborator

Hospital de Sant Pau

OTHER

Sponsor Role collaborator

Institut Pere Mata

UNKNOWN

Sponsor Role collaborator

Parc Taulí Hospital Universitari

OTHER

Sponsor Role collaborator

Hospital de Mataró

OTHER

Sponsor Role collaborator

Centre d'Higiene Mental Les Corts

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Hospital Universitario Marqués de Valdecilla

OTHER

Sponsor Role collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

Fundació Vidal i Barraquer

UNKNOWN

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susana Ochoa, Phd

Role: PRINCIPAL_INVESTIGATOR

Parc Sanitari Sant Joan de Deu

Central Contacts

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Susana Ochoa, Phd

Role: CONTACT

936406350 ext. 12538

Raquel Lopez, Msc

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 38586292 (View on PubMed)

Other Identifiers

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PI21/00012

Identifier Type: -

Identifier Source: org_study_id

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