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

Psychosis Clinical Trial

— MCTf  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05358457
• Other study ID #: PI21/00012
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2022
• Source: Fundació Sant Joan de Déu
• Contact: Susana Ochoa, Phd
• Phone: 936406350
• Email: susana.ochoa[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Mental Disorders
• Mother-Child Relations
• Psychosis
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (13)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WAIS-IV (Weschler Adults Intelligence Scale, 1955)	vocabulary subscale to explore premorbid IQ	baseline
Other	TMT-A Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	baseline
Other	TMT-A Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	up to 11 weeks
Other	TMT-B Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	baseline
Other	TMT-B Trail Making Test, Retain, 1993	Visual attention and task switching. Higher values represent a worse outcome.	up to 11 weeks
Other	WAIS-IV (Weschler Adults Intelligence Scale, 1955)	Digits subscale. Higher values represent a better outcome.	baseline
Other	WAIS-IV (Weschler Adults Intelligence Scale, 1955)	Digits subscale. Higher values represent a better outcome.	up to 11 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)	The scales assess social perception. There are no ranges	baseline
Secondary	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
Secondary	FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)	The scale include 3 dimensions: relationships, development and stability.	baseline
Secondary	FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)	The scale include 3 dimensions: relationships, development and stability.	up to 11 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)	The scale assess affective symptoms. Higher values indicate more symptoms.	baseline
Secondary	CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)	The scale assess affective symptoms. Higher values indicate more symptoms.	up to 11 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CD Risk 17 (Serrano et al., 2013)	The scale assess resilience with a total of 17 items.	baseline
Secondary	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
Secondary	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
Secondary	SSQ Self Stigma Questionnaire (Ochoa et al.,2015)	The scales assess self-stigma. It consists of 14 items and is self-administered	baseline
Secondary	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
Secondary	PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)	The scale assess attachment styles	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	KASI The Knowledge About Schizophrenia Interview	Scale to asses the beliefs of the disorder	baseline
Secondary	KASI The Knowledge About Schizophrenia Interview	Scale to asses the beliefs of the disorder	up to 11 weeks