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

May 2, 2022 updated by: Fundació Sant Joan de Déu

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Control group
The control group will be receive treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Time Frame: baseline
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)
Time Frame: up to 11 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
Time Frame: baseline
Scale for the assessment of the most cognitive biases in psychosis.Higher values represent more biases.
baseline
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
Time Frame: up to 11 weeks
Scale for the assessment of the most cognitive biases in psychosis. Higher values represent more biases.
up to 11 weeks
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
Time Frame: baseline
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
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
Time Frame: up to 11 weeks
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
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
Time Frame: baseline
The scale assess the attributional style in different situations.There are no ranges.
baseline
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
Time Frame: up to 11 weeks
The scale assess the attributional style in different situations.There are no ranges.
up to 11 weeks
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
Time Frame: baseline
The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.
baseline
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
Time Frame: up to 11 weeks
The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.
up to 11 weeks
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Time Frame: baseline
20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.
baseline
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Time Frame: after the intervention
20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.
after the intervention
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
Time Frame: baseline
The scales assess social perception. There are no ranges
baseline
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
Time Frame: up to 11 weeks
The scales assess social perception. There are no ranges
up to 11 weeks
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
Time Frame: baseline
The scale include 3 dimensions: relationships, development and stability.
baseline
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
Time Frame: up to 11 weeks
The scale include 3 dimensions: relationships, development and stability.
up to 11 weeks
SWLS Satisfaction with life style (Pons et al., 2002)
Time Frame: baseline
The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.
baseline
SWLS Satisfaction with life style (Pons et al., 2002)
Time Frame: up to 11 weeks
The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.
up to 11 weeks
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
Time Frame: baseline
This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology
baseline
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
Time Frame: up to 11 weeks
This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology
up to 11 weeks
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
Time Frame: baseline
The scale assess affective symptoms. Higher values indicate more symptoms.
baseline
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
Time Frame: up to 11 weeks
The scale assess affective symptoms. Higher values indicate more symptoms.
up to 11 weeks
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
Time Frame: baseline
The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision
baseline
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
Time Frame: up to 11 weeks
The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision
up to 11 weeks
EEAG-Scale of Functioning (Endicot et al., 1976)
Time Frame: baseline
This scale measures the general functioning of the patient on a scale that ranges from 0 to 100.
baseline
EEAG-Scale of Functioning (Endicot et al., 1976)
Time Frame: up to 11 weeks
This scale measures the general functioning of the patient on a scale that ranges from 0 to 100.
up to 11 weeks
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
Time Frame: baseline
Questionnaire to explore personal self-esteem understood as feelings of personal worth and self-respect. The scale consist of 10 items.
baseline
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
Time Frame: up to 11 weeks
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
CD Risk 17 (Serrano et al., 2013)
Time Frame: baseline
The scale assess resilience with a total of 17 items.
baseline
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
Time Frame: baseline
The scale includes 8 scales that assess the frequency of use of primary coping strategies and the perception of coping self-efficacy.
baseline
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
Time Frame: up to 11 weeks
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
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
Time Frame: baseline
The scales assess self-stigma. It consists of 14 items and is self-administered
baseline
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
Time Frame: up to 11 weeks
The scales assess self-stigma. It consists of 14 items and is self-administered
up to 11 weeks
PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)
Time Frame: baseline
The scale assess attachment styles
baseline
CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)
Time Frame: baseline
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
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
Time Frame: baseline
It is an instrument to assess symptoms in adolescents between 11 and 18 years old.
baseline
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
Time Frame: up to 11 weeks
It is an instrument to assess symptoms in adolescents between 11 and 18 years old.
up to 11 weeks
KASI The Knowledge About Schizophrenia Interview
Time Frame: baseline
Scale to asses the beliefs of the disorder
baseline
KASI The Knowledge About Schizophrenia Interview
Time Frame: up to 11 weeks
Scale to asses the beliefs of the disorder
up to 11 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Time Frame: baseline
vocabulary subscale to explore premorbid IQ
baseline
TMT-A Trail Making Test, Retain, 1993
Time Frame: baseline
Visual attention and task switching. Higher values represent a worse outcome.
baseline
TMT-A Trail Making Test, Retain, 1993
Time Frame: up to 11 weeks
Visual attention and task switching. Higher values represent a worse outcome.
up to 11 weeks
TMT-B Trail Making Test, Retain, 1993
Time Frame: baseline
Visual attention and task switching. Higher values represent a worse outcome.
baseline
TMT-B Trail Making Test, Retain, 1993
Time Frame: up to 11 weeks
Visual attention and task switching. Higher values represent a worse outcome.
up to 11 weeks
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Time Frame: baseline
Digits subscale. Higher values represent a better outcome.
baseline
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Time Frame: up to 11 weeks
Digits subscale. Higher values represent a better outcome.
up to 11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Sant Joan de Déu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parc Sanitari Sant Joan de Déu
Hospital del Mar
Hospitales Universitarios Virgen del Rocío
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital de Mataró
Hospital Universitario Marqués de Valdecilla
Hospital Parc Taulí, Sabadell
Hospital Sant Joan de Deu
Hospital de Sant Pau
Centre d'Higiene Mental Les Corts
Institut Pere Mata
Fundació Vidal i Barraquer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susana Ochoa, PhD, Parc Sanitari Sant Joan de Deu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI21/00012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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