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

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: Not yet recruiting
• Conditions: Psychosis; Mother-Child Relations
• Intervention / Treatment: Behavioral: Familiar Metacognitive Training

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: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana Ochoa, Phd; Phone Number: 12538 936406350; Email: susana.ochoa@sjd.es
• Study Contact Backup: Name: Raquel Lopez, Msc; Email: raquel.lopezc@sjd.es

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	The scales assess social perception. There are no ranges	baseline
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)	The scales assess social perception. There are no ranges	up to 11 weeks
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)	The scale include 3 dimensions: relationships, development and stability.	baseline
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)	The scale include 3 dimensions: relationships, development and stability.	up to 11 weeks
SWLS Satisfaction with life style (Pons et al., 2002)	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)	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)	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)	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)	The scale assess affective symptoms. Higher values indicate more symptoms.	baseline
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)	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)	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)	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)	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)	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)	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)	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)	The scale assess resilience with a total of 17 items.	baseline
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)	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)	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)	The scales assess self-stigma. It consists of 14 items and is self-administered	baseline
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)	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)	The scale assess attachment styles	baseline
CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)	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)	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)	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	Scale to asses the beliefs of the disorder	baseline
KASI The Knowledge About Schizophrenia Interview	Scale to asses the beliefs of the disorder	up to 11 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
WAIS-IV (Weschler Adults Intelligence Scale, 1955)	vocabulary subscale to explore premorbid IQ	baseline
TMT-A Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	baseline
TMT-A Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	up to 11 weeks
TMT-B Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	baseline
TMT-B Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	up to 11 weeks
WAIS-IV (Weschler Adults Intelligence Scale, 1955)	Digits subscale. Higher values represent a better outcome.	baseline
WAIS-IV (Weschler Adults Intelligence Scale, 1955)	Digits subscale. Higher values represent a better outcome.	up to 11 weeks

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: 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: Principal Investigator: Susana Ochoa, PhD, Parc Sanitari Sant Joan de Déu

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID 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