Benefits of Combining Metacognitive Training (MCT) With Cognitive Remediation (CR) in the Recovery of Patients With Psychotic Spectrum Disorders (CR+MCTp)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- CLINICAL RECOVERY
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of combined REHACOP + MCT alone in persons with nonaffective psychotic disorder in terms of recovery. The main questions it aims to answer are:
- Does combined REHACOP + MCT therapy increase the clinical recovery in persons with nonaffective psychotic disorder (compared to MCT alone)?
- What is the impact of combined REHACOP + MCT therapy compared to MCT therapy alone on personal/psychological recovery, cognitive biases, and social cognition, taking gender differences into account?
- What is the durability of the effects of combined REHACOP + MCT therapy compared to MCT therapy alone on clinical recovery, personal recovery, cognitive biases, and social cognition in the long term?
Researchers will compare REHACOP+MCT therapy to MCT alone to see if there are differences in personal/psychological recovery.
Participants will:
- Participate in Metacognitive Training or in combined REHACOP + Metacognitive training therapy.
- Do 8 weekly sessions of 45-60 minutes (MCT group).
- Do 12 weekly sessions of 45-60 minutes (RECHACOP+MCT group).
- Visit the clinic for checkups and tests.
- Answer self-administered tests.
详细描述
This project is aimed at responding to one of the Challenges of the Spanish Strategy for Science, Technology and Innovation, specifically Challenge 1: Health, demographic change and well-being. One of the work areas that are located within this challenge is the Clinical and Translational Research based on the evidence of scientific and technological knowledge.The present proposal is clearly within the framework of clinical-translational investigation, since most of the entities participating attend persons with psychotic disorders, thereby ensuring the translation of investigation to the clinical setting. In addition, this project includes investigators with wide experience in psychological interventions in the target population and with previous experience in investigation in this area. Lastly, it is of note that the benefits of this investigation are not only of a scientific nature but also involve clinical investigation with a direct repercussion on improvement in the health care of people with psychotic disorders, enabling the design of new strategies of psychological interventions. Besides, the present proposal is aimed at responding to the challenges of our society, contributing to covering the needs of persons with psychotic disorder as well as developing the most effective therapeutic strategies to improve aspects related to clinical and personal recovery. Specifically, this project will allow making changes that will improve the quality of health care to the target population incorporating the combinated use of scientifically proven therapeutic strategies to health care services. In short, this project aims to promote innovation in the provision of mental health services, being the starting point in analyzing the efficacy of combined psychological therapies versus monotherapies address to improve of metacognitive processes.
- General and specific objectives. General objective: Compare the efficacy of combined REHACOP + MCT therapy vs. MCT alone in persons with nonaffective psychotic disorder in terms of recovery.
Specific objectives:
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery (clinical remission and functional recovery, the latter understood in terms of cognitive, occupational and social functioning).
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on personal/psychological recovery.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone on cognitive biases and social cognition.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to gender.
- Evaluate the effects of combined REHACOP + MCT therapy vs. MCT alone according to self-esteem, quality of life and stigma.
- Evaluate the maintenance of the effects of combined REHACOP + MCT therapy vs. MCT alone on clinical recovery, personal recovery, cognitive biases and social cognition in the long term.
- Methodology
Design:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of one of the e following diagnostics according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): schizophrenia, schizophreniform disorder, delusional disorder, brief psychotic disorder, schizoaffective disorder, and non specified schizophrenia spectrum disorder and other psychotic disorders.
- •Be in a stable clinical phase (without psychiatric hospitalization in the last 3 months).
- •Have good adherence to pharmacological treatment.
- •T-score < 40 in any cognitive outcome measured by TAVEC, CPT-IP, TMT, Stroop, WSCT, FAS and WAIS (Vocabulary, Digit Forward, Digit Backwards and Digit Symbol Coding.
- •Willing to participate in the study expressed by providing signed informed consent.
排除标准
- •Presence of traumatic brain lesion, dementia or intellectual discapacity (IQ <70).
- •Positive and Negative Syndrome Scale (PANSS) score >= 5 in hostility and lack of cooperation and >= 6 in suspiciousness.
- •Presence of an additional diagnosis of severe disorder related to substances.
- •Having participated in a CR and/or MCT intervention in the year prior to incorporation into the study.
结局指标
主要结局
CLINICAL RECOVERY
时间窗: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
Includes: a) CLINICAL REMISSION: based on the criteria of the Remission in Schizophrenia Working Group (RSWA) of Andreasen et al. (2005), which includes one criterium of severity measured with 7 items of the PANSS scale and one temporal criterium that requires the maintenance of the criterium of severity during 6 months or more; and b) FUNCTIONAL RECOVERY: based on the criteria defined by the German Research Network on Schizophrenia (GRNS group) (Schennach-Wolff et al., 2009), which includes one criterium of severity based on the GAF scale and one temporal criterium of maintaining the criterium of severity during 6 months or more.
FUNCTIONAL RECOVERY
时间窗: It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.
To be measured with the STORI test.
次要结局
- Social Cognition. Recognition of emotion(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Assesment instruments(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Ball task (Dudley et al.,1997).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Social Cognition. Hinting Task (Corcoran et al., 1995; Gil et al., 2012)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Social Cognition. Internal, Personal and Situational Attributions Questionnaire (IPSAQ) (Kinderman & Bentall, 1996; Diez-Alegría, 2006)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Cognitive Bias Questionnaire (CBQ) (Peters et al., 2013; Gutiérrez-Zotes, in press).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004; Guitiérrez-Zotes et al., 2012).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Cognitive functioning.(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Rey Auditory Verbal Learning Test (RAVLT) (Rey, 1964)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Trail Making Test (TMT-A) (Reintan, 1993)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Letter-number sequencing (Wechsler Adult Intelligence Scale [WAIS]) (Weschler, 1999)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Social Functioning Scale (SFS) (Birchwood et al., 1990; Torres and Olivares, 2000).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Continuous Performance Test II (CPT-II) (Conners, 2000); Trail Making Test (TMT) (Reitan,1993).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Wisconsin Card Sorting Test (WCST) (Bergs et al., 1948)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Trail Making Test (TMT-B) (Reitan, 1993)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Stroop Color and Word Test (Stroop, 1935)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Controlled Oral Word Association Test (COWAT) (Benton&Hamsher, 1976)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- The Stages of Recovery Instrument (STORI) (Andresen et al., 2006; Lemos et al., 2015)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Global Assessment Functioning (GAF) (Endicott et al., 1976).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Positive and negative syndrome scale (PANSS) (Kay et al., 1987; Peralta and Cuesta, 1995).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- World Health Organization Disability Assessment Schedule (WHO-DAS-II) (Üstun et al., 1988; Vázquez-Barquero et al., 2000)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- WHO Quality of Life-BREF 26. (WHOQOL-BREF) (Üstun et al., 1988; Vázquez-Barquero et al., 2000).(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Internalized Stigma of Mental Illness Scale (ISMI) (Ritsher, Otilingama, Grajalesa, 2003)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
- Rosenberg self-esteem scale (RSES) (Rosenberg et al., 1965; Atienza, Balaguer & Moreno, 2000)(It will be administered 1 time before de treatment, 1 time after finishing the treatment and 1 time after 6 months completing the intervention.)
研究者
Ana Barajas Velez
Associate Professor
Universitat Autonoma de Barcelona