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

NCT05358457 | Unknown

• 1 other identifier: PI21/00012
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychosis; Mother-Child Relations

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (37)

• CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021

  baseline

• CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021

  up to 11 weeks

• Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)

  baseline

• Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)

  up to 11 weeks

• IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)

  baseline

Other Outcomes (7)

• WAIS-IV (Weschler Adults Intelligence Scale, 1955)

  baseline

• TMT-A Trail Making Test, Retain, 1993

  baseline

• TMT-A Trail Making Test, Retain, 1993

  up to 11 weeks

Study Arms (2)

Online Familiar Metacognitive Training

EXPERIMENTAL

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.

Behavioral: Familiar Metacognitive Training

Control group

NO INTERVENTION

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

Interventions

Familiar Metacognitive Training 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.

Online Familiar Metacognitive Training

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 38586292 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Susana Ochoa, Phd

  Parc Sanitari Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Ochoa, Phd

CONTACT

936406350; susana.ochoa@sjd.es

Raquel Lopez, Msc

CONTACT

raquel.lopezc@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blind to the group that ows the patients included
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 3, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 3, 2022

Record last verified: 2022-04