Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) in Mothers With Psychosis and Their Adolescent Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluator will be blind to the group that ows the patients included
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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,
- •interested in the group. Exclusion criteria: Head injury or intellectual disabillity (premorbid IQ <=70).
结局指标
主要结局
BCIS Beck Cognitive and Insight Scale (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
时间窗: 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.
次要结局
- CTQ-SF Childhood Trauma Questionnaire (Bernstein et al., 1994; Hernández et al., 2012)(baseline)
- Jumping to conclusions (Garety et al., 1991; Dudley et al., 1997)(up to 11 weeks)
- SFRT-2 .Situational feature recognition test 2 (Gomez-Gastiasoro et al., 2018)(up to 11 weeks)
- SWLS Satisfaction with life style (Pons et al., 2002)(up to 11 weeks)
- EEAG-Scale of Functioning (Endicot et al., 1976)(up to 11 weeks)
- SSQ Self Stigma Questionnaire (Ochoa et al.,2015)(up to 11 weeks)
- CBQ Cognitive Biais Questionnaire (Peters et al., 2013; Guiterrez-Zotes et al.,2021(up to 11 weeks)
- CDSS. Calgary Depression Scale for Schizophrenia (Addington et al., 1990)(up to 11 weeks)
- Rosenberg Self-Esteem Scale (Martín Albó et al., 2007)(up to 11 weeks)
- IPSAQ, Internal, personal and situational Attributions Questionnaire.(Bentall et al., 1991; Diez-Alegria, 2006)(up to 11 weeks)
- Face Test (Baron Cohen, 1997; Huerta-Ramos et al., 2021)(after the intervention)
- Coping Strategies Inventory (Tolbin et al., 1989; Cano et al; 2007)(up to 11 weeks)
- The Hinting Task (Corcoran et al., 1995; Gil et al., 2012)(up to 11 weeks)
- PANSS.Positive and Negative Syndrome Scale (Kay et al., 1987; Peralta and Cuesta., 1994)(up to 11 weeks)
- SUMD. Scale of Unaweressness of Mental Disorder (Amador., 1993; Ruiz et al., 2008)(up to 11 weeks)
- CD Risk 17 (Serrano et al., 2013)(baseline)
- FES Family Enviromental Scale (Moos et al., 1987; Fernandez-Ballesteros., 1995)(up to 11 weeks)
- PAM Psychosis Attachment Measure (Berry et al., 2006; Sheinbaum et al., 2013)(baseline)
- YSR Youth Self-Report (Achembach., 1991; Lemos et al., 2002)(up to 11 weeks)
- KASI The Knowledge About Schizophrenia Interview(up to 11 weeks)