Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- Frankfurt Complaint Questionnaire (FBF-3)
研究概览
简要总结
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
详细描述
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy (IPT) appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy (EMT) in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
Discussion: This study provides the description of a clinical trial based on specific psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to improve lasting clinical and functional outcome.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having ≥ 5 years since disease onset and aged between 25 and 65 years.
- •Being in a stable phase of the illness and under psychopharmacological treatment.
- •Having negative or attenuated positive symptoms.
- •Failing to achieve premorbid functioning in terms of education, work and/or social life.
- •Agreeing to participate in the study and giving written informed consent.
排除标准
- •Presenting organic brain pathology.
- •Presenting intellectual developmental disorder according to DSM-5 criteria.
研究组 & 干预措施
Study procedure
An experimental group the psychological treatment includes 50 sessions of integrated psychological therapy (IPT) (focused on attentional skills training, social perception skills training, verbal communication skills, social skills training, interpersonal problems solving skills) and 10 sessions of specific emotional management therapy (EMT), designed for this research and based on the contents developed by Hodel, Kern and Brenner.
干预措施: Integrated Psychological Therapy (Behavioral)
Treatment as usual
The treatment as usual is pharmacological treatment and activities in a Day Care Center.
结局指标
主要结局
Frankfurt Complaint Questionnaire (FBF-3)
时间窗: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up
(Assessing change)This is a self-report test composed of 98 items measuring the presence of the "basic" symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60
次要结局
- Screen for Cognitive Impairment in Psychiatry (SCIP)(Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up)
- Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)(Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up)
- Wisconsin Card Sorting Test (WCST)(Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up)
- Social Functioning Scale (SFS)(Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up)
- Lancashire Quality of Life Profile (LQoLP)(Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up)
研究者
Karmele Salaberria Irizar
Phd.-Lecturer
University of the Basque Country (UPV/EHU)