A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
In the first year of treatment after a FE of SCZ, 75% to 90% of patients achieve remission from psychotic symptoms. However, approximately 40% of FE patients are non-adherent to medication regimes and more than 60% have intermittent periods of gaps of non-adherence. Relapse rates are high with 82% of patients relapsing at least once within 5 years. Unfortunately even amongst those who do achieve full remission from psychotic symptoms, functional recovery remains a major challenge for patients. All the evidence suggests that individuals with SCZ do best with a combination of pharmacology and psychosocial intervention. Cognitive-behavior therapy (CBT) is gaining recognition as an effective treatment in SCZ and is in fact the only psychosocial treatment in SCZ with proven durability at short term follow-up. Although it is currently being used, the investigators need to learn more about the impact of CBT on FE SCZ especially as experts are advocating for CBT to be a critical component of FE clinical services.
详细描述
The primary problem to be addressed is the incomplete functional recovery following a FE of SCZ and whether CBT is an effective treatment to aid this recovery. If CBT were to positively impact recovery in the FE we then need to address (i) which mechanisms are responsible for this improvement, and (ii) whether this treatment is effective for all FE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stabilized outpatients,
- •ages 16 to 35
- •meet DSM-IV criteria for: schizophrenia, schizophreniform disorder, brief psychotic disorder, delusional disorder, schizoaffective disorder, substance induced psychotic disorder, or psychotic disorder NOS. Participants who also meet DSM-IV criteria for substance abuse or dependence will not be excluded.
- •are competent and willing to give consent
- •are within 12 months of admission to the FEPP for a FE.
排除标准
- •serious risk of suicide or violence to others
- •a primary diagnosis of drug-induced psychosis or psychosis due to a general medical condition.
结局指标
主要结局
Depression
时间窗: 18 months
Substance use
时间窗: 18 months
Alcohol and Drug Use
时间窗: 18 months
Medication adherenceAdaptation to illness
时间窗: 18 months
Self Esteem
时间窗: 18 months
Coping Skills (MACS)
时间窗: 18 months
Social Functioning
时间窗: 18 months
Positive & negative symptoms
时间窗: 18 months
Individual dimensions of psychotic symptoms
时间窗: 18 months
次要结局
未报告次要终点