Cognitive Enhancement for Persistent Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Persistent Negative Symptoms
研究概览
简要总结
This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.
详细描述
This project will conduct a confirmatory efficacy trial to examine the efficacy of Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST) for the treatment of schizophrenia patients with significant and persistent negative symptoms. A total of 90 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of CET or EST. Comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of CET and EST for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of CET and EST effects on negative symptoms and functioning.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and:
- •are between 18-60 years of age;
- •have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
- •have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
- •have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
- •have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
- •have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
- •have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
- •have had changes to their primary antipsychotic medication within the previous 3 months;
- •have current IQ > 80; and
- •are able to read (sixth grade level or higher) and speak fluent English. -
排除标准
- •Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include:
- •the presence of organic brain syndrome;
- •comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
- •persistent suicidal or homicidal behavior;
- •significant clinician-estimated medication non-adherence; and
- •SCID-verified substance use disorder.
研究组 & 干预措施
Cognitive Enhancement Therapy
This research treatment aims to help with problems in thinking, planning, and socialization. Participants begin with cognitive training using computer software programs. They also participate in a small social-cognitive group to learn about their condition and how to act wisely in social situations by developing the abilities needed to understand another person's perspective, evaluate social contexts, and be foresightful.
Time commitment: about 3½ hours per week; Location: Pittsburgh, PA only
干预措施: Cognitive Enhancement Therapy (Behavioral)
Enriched Supportive Therapy
This research treatment uses individual supportive therapy to help patients learn about schizophrenia, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies.
Time commitment: about 2 hours per week; Location: Pittsburgh, PA only
干预措施: Enriched Supportive Therapy (Behavioral)
结局指标
主要结局
Change in Persistent Negative Symptoms
时间窗: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months
Negative symptoms will be assessed using the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a structured interview measure of expressive and motivational negative symptoms consisting of 13 items based on a standardized interview with anchor points for each rating. This measure was developed to address the limitations of previous negative symptom measures and designed for use in clinical trials of negative symptom therapeutics. This outcome has two endpoints that will be evaluated in this trial, persistent negative symptoms related to expression (Expression subscale) and persistent negative symptoms related to motivation/pleasure (Motivation/Pleasure subscale). Items are rated on a 0 to 4 scale, with higher scores indicating greater negative symptom severity.
次要结局
- Change in Functioning(Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months)
研究者
Shaun M. Eack
Professor
University of Pittsburgh