Cognitive Behavioural Therapy- Social Functioning In Adolescence With Recent Onset Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Negative symptoms
研究概览
简要总结
Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede social functioning. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements. However, the therapy has not yet been investigated in a recent-onset population.
Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients with recent onset schizophrenia.
Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa) in a recent-onset population will result in a substantial reduction in severity of negative symptoms, in particular social withdrawal.
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The investigators expected that CBTsa would lead to an improvement in terms of Quality of Life and overall functioning.
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The investigators expected this intervention to result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning.
Study design: Single blind randomized controlled trial with 6 month-follow up. Study population: Patients between 18 and 35 years old with negative symptoms of at least moderate severity, and who have been recently (< 2yrs) diagnosed with schizophrenia.
Intervention (if applicable): Individual and group-based CBT intervention targeting social withdrawal.
Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality of life, Productivity losses.
详细描述
There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation; thereby reducing the high yearly costs of schizophrenia.
Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms; a subgroup that has always believed to be highly treatment resistant. The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede functioning. Its primary focus is to help patients overcome isolation and inactivity, thereby improve quality of life, rather than primarily focussing on the reduction of psychotic symptoms. Grant, Beck and colleagues found that patients treated with CBT not only showed more improvement in global functioning than patients in the Standard Treatment condition, they also showed a greater reduction in avolition/apathy and psychotic symptoms. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements.
Thus far, this intervention had only been investigated in patients with chronic schizophrenia although there is increasing evidence that social withdrawal is also prominent in the early phase of the illness. Moreover, there is growing consensus that early intervention is more effective in improving illness course than intervention at a later stage of the illness.
In the present study the investigators aimed to examine whether a relatively short, partly group based CBT targeting negative symptoms in recent-onset schizophrenia patients results in reduced social withdrawal, need for care and improvement in quality of life and in overall functioning compared to treatment as usual.
Primary Objective:
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)
盲法说明
Randomisation is coordinated a staff member of the psychosis department who is not involved in the research team and not familiar with both the assessments or intervention procedure. The results of the randomization is concealed from the assessors. Every effort has been made to keep assessors blind to treatment condition, using the following strategies: research workers were not involved in the randomization process, therapists and research workers made use of different (secured) agendas, and work locations / rooms in order tot minimize the chance of potential blind breaks; patients will be frequently reminded by assessors not to talk about treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recent onset schizophrenia or related disorder (start antipsychotic medication <2 yr);
- •Social withdrawal (> 3 moderate severity on the PANSS N4; Passive/apathic social withdrawal; range 0-7);
- •Aged 18-35 years;
- •Fluent in Dutch
- •Able and willing to give informed consent
排除标准
- •Younger than eighteen years of age;
- •No mastery of the Dutch language;
- •Negative symptoms as a consequence of positive symptoms (e.g. withdrawal due to paranoid delusions). Positive symptoms as such are not an exclusion criterion; only when they are considered to be the primary cause of the negative symptoms, in which case CBT focused on positive symptoms or another type of intervention for positive symptoms is called for.
研究组 & 干预措施
CBT-SA
- Group sessions for 4 weeks, two sessions per week, 60 minutes per session, two trainers (a CBT therapist and a CBT assistant); eight participants, and;
- Individual sessions (crystallizing learned skills, focus on individual needs) during 6-8 weeks, one session per week, 45 minutes per session
干预措施: CBT-SA (Behavioral)
CBT-SA
- Group sessions for 4 weeks, two sessions per week, 60 minutes per session, two trainers (a CBT therapist and a CBT assistant); eight participants, and;
- Individual sessions (crystallizing learned skills, focus on individual needs) during 6-8 weeks, one session per week, 45 minutes per session
干预措施: Standard Treatment (Behavioral)
Standard Treatment
Participants in both study conditions will receive ST. Participants are hospitalized or attending day-treatment at the Department of Early Psychosis, Amsterdam, the psychosis department of the ABC team, Utrecht, Parnassia Den Haag and collaborating (local community) mental health centers.
干预措施: Standard Treatment (Behavioral)
结局指标
主要结局
Negative symptoms
时间窗: 3 months (at study completion)
Negative symptoms as measured with PANSS
Level of social engagement
时间窗: 3 months (at study completion)
Level of social engagement as measured by experiences sampling method
次要结局
- Quality of Life(3 months (at study completion))
- Positive and General Symptomatology(3 months (at study completion))
- Global functioning(3 months (at study completion))
- Need for care(3 months (at study completion))
- Productivity losses(3 months (at study completion))
- Inhibition/ Activation(3 months (at study completion))
- Depression(3 months (at study completion))
研究者
Lieuwe de Haan, PhD
Professor of Psychotic Disorders
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)