Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
- Conditions
- PsychosisMother-Child Relations
- Interventions
- Behavioral: Familiar Metacognitive Training
- Registration Number
- NCT05358457
- Lead Sponsor
- Fundació Sant Joan de Déu
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 48
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Online Familiar Metacognitive Training 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.
- Primary Outcome Measures
Name Time Method BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012) 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.
- Secondary Outcome Measures
Name Time Method CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012) 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.
Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997) 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.
SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018) up to 11 weeks The scales assess social perception. There are no ranges
SWLS Satisfaction with life style (Pons et al., 2002) up to 11 weeks The scale asses the degree of satisfaction of the person with their life in 5 items. Self-administered.
EEAG-Scale of Functioning (Endicot et al., 1976) up to 11 weeks This scale measures the general functioning of the patient on a scale that ranges from 0 to 100.
SSQ Self Stigma Questionnaire (Ochoa et al.,2015) up to 11 weeks The scales assess self-stigma. It consists of 14 items and is self-administered
CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021 up to 11 weeks Scale for the assessment of the most cognitive biases in psychosis. Higher values represent more biases.
CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990) up to 11 weeks The scale assess affective symptoms. Higher values indicate more symptoms.
Rosenberg Self-Esteem Scale (Martín Albó et al., 2007) 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.
IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006) up to 11 weeks The scale assess the attributional style in different situations.There are no ranges.
Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021) after the intervention 20 photographs that express ten basic and ten complex emotions. Possible range 0-20. Higher values representa better outcome.
Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007) 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.
The Hinting Task (Corcoran et al., 1995; Gil et al., 2012) up to 11 weeks The scale asses Theory of Mind. Possible Range 0-12. Higher values represent a better outcome.
PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994) up to 11 weeks This scale measure 30 symptoms on a scale 1-7, with higher scores indicating greater psychopathology
SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008) up to 11 weeks The scale assess awareness of illness in people with schizophrenia, according to the evaluator´s vision
CD Risk 17 (Serrano et al., 2013) baseline The scale assess resilience with a total of 17 items.
FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995) up to 11 weeks The scale include 3 dimensions: relationships, development and stability.
PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013) baseline The scale assess attachment styles
YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002) up to 11 weeks It is an instrument to assess symptoms in adolescents between 11 and 18 years old.
KASI The Knowledge About Schizophrenia Interview up to 11 weeks Scale to asses the beliefs of the disorder