PsychosisMCTfNCT05358457
Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
A study testing Familiar Metacognitive Training in people with Psychosis and Mother-Child Relations, run by Fundació Sant Joan de Déu.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Psychosis, Mother-Child Relations
- What is being tested?
- Familiar Metacognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
Raquel Lopez, Msc contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis, Mother-Child Relations
- Being tested
- Familiar Metacognitive Training
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familiar Metacognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Familiar Metacognitive Training |
| Control group | No intervention | The control group will be receive treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 11 weeks
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after the intervention
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
The scales assess social perception. There are no ranges
Measured: baseline
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
The scales assess social perception. There are no ranges
Measured: up to 11 weeks
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
The scale include 3 dimensions: relationships, development and stability.
Measured: baseline
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
The scale include 3 dimensions: relationships, development and stability.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 11 weeks
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
The scale assess affective symptoms. Higher values indicate more symptoms.
Measured: baseline
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
The scale assess affective symptoms. Higher values indicate more symptoms.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 11 weeks
CD Risk 17 (Serrano et al., 2013)
The scale assess resilience with a total of 17 items.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
The scales assess self-stigma. It consists of 14 items and is self-administered
Measured: up to 11 weeks
PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)
The scale assess attachment styles
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 11 weeks
KASI The Knowledge About Schizophrenia Interview
Scale to asses the beliefs of the disorder
Measured: baseline
KASI The Knowledge About Schizophrenia Interview
Scale to asses the beliefs of the disorder
Measured: up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parrallel Assigment. This is a randomized clinical trial in which some patients receive the MCTf intervention and others treatment as usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Hospital de Sant Pau, Institut Pere Mata, Parc Taulí Hospital Universitari, Hospital de Mataró, Centre d'Higiene Mental Les Corts, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital del Mar, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío, Fundació Vidal i Barraquer, Hospital Sant Joan de Deu
- Responsible party
- Sponsor
- Investigators
- Susana Ochoa, Phd, Principal investigator, Parc Sanitari Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358457
- Sponsor's protocol ID
- PI21/00012
- Acronym
- MCTf
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38586292
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children
- ClinicalTrials.gov ID
- NCT05358457
- Acronym / sponsor ID
- MCTf / PI21/00012
- Conditions
- Psychosis, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Hospital de Sant Pau, Institut Pere Mata, Parc Taulí Hospital Universitari, Hospital de Mataró, Centre d'Higiene Mental Les Corts, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospital del Mar, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío, Fundació Vidal i Barraquer, Hospital Sant Joan de Deu
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parrallel Assigment. This is a randomized clinical trial in which some patients receive the MCTf intervention and others treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Online Familiar Metacognitive Training | Experimental | Behavioral: Familiar Metacognitive TrainingMetacognitive 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. |
| Control group | No intervention | –The control group will be receive treatment as usual (TAU). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Familiar Metacognitive TrainingThe 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. | Behavioural | Online Familiar Metacognitive Training |
Primary outcome
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.
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.
37 secondary outcomes
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
Time frame: baseline
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021
Time frame: up to 11 weeks
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
Time frame: baseline
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)
Time frame: up to 11 weeks
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
Time frame: baseline
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)
Time frame: up to 11 weeks
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
Time frame: baseline
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)
Time frame: up to 11 weeks
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Time frame: baseline
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Time frame: after the intervention
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
Time frame: baseline
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)
Time frame: up to 11 weeks
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
Time frame: baseline
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)
Time frame: up to 11 weeks
SWLS Satisfaction with life style (Pons et al., 2002)
Time frame: baseline
SWLS Satisfaction with life style (Pons et al., 2002)
Time frame: up to 11 weeks
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
Time frame: baseline
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)
Time frame: up to 11 weeks
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
Time frame: baseline
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)
Time frame: up to 11 weeks
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
Time frame: baseline
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)
Time frame: up to 11 weeks
EEAG-Scale of Functioning (Endicot et al., 1976)
Time frame: baseline
EEAG-Scale of Functioning (Endicot et al., 1976)
Time frame: up to 11 weeks
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
Time frame: baseline
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)
Time frame: up to 11 weeks
CD Risk 17 (Serrano et al., 2013)
Time frame: baseline
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
Time frame: baseline
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)
Time frame: up to 11 weeks
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
Time frame: baseline
SSQ Self Stigma Questionnaire (Ochoa et al.,2015)
Time frame: up to 11 weeks
PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)
Time frame: baseline
CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)
Time frame: baseline
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
Time frame: baseline
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)
Time frame: up to 11 weeks
KASI The Knowledge About Schizophrenia Interview
Time frame: baseline
KASI The Knowledge About Schizophrenia Interview
Time frame: up to 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 38586292Ochoa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Lopez, Msc contact
Susana Ochoa, Phd principal investigator
Parc Sanitari Sant Joan de Deu
Questions about this trial
What is this clinical trial studying?
A study testing Familiar Metacognitive Training in people with Psychosis and Mother-Child Relations, run by Fundació Sant Joan de Déu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susana Ochoa, Phd (936406350 ext. 12538, susana.ochoa@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.