Piloting of an Intervention to Reduce Problematic Alcohol Use in Early Phase Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Alcohol consumption (mL per day)
研究概览
简要总结
A focus of research for youth and Emerging Adults with early phase psychosis (EPP) has been cannabis use. However, this focus has led to overlooking the possible negative influence of another legal recreational drug, alcohol. Previous studies our research group has done have demonstrated that over use of alcohol reduces the effectiveness of early intervention in psychosis treatment services. These treatment services are wrap around services that address medical, and social needs of young people with psychosis. Individuals with alcohol use disorder and EPP have fewer positive symptoms such as hallucinations which are the aspects of psychotic disorders that respond most readily to medication but have greater levels of depressive symptoms. Biologically, we can see the negative impact of alcohol on brain structure in our MRI studies. Our aim presented in this grant is to pilot a psychosocial intervention using cognitive enhancement therapy to reduce alcohol consumption in individuals with early phase psychosis. This intervention has shown promise in reducing alcohol use in individuals with long standing schizophrenia and compare it to treatment as usual which involves brief (1 session) psychoeducation. The investigators hope to reduce substance use in young people in the early stages of a psychotic disorder and improve their odds of a full recovery. In addition to measuring symptoms and hospitalizations, this trial will measure what are called social determinants of health such as return to school or work and resumption of relationships. These variables have not been measured previously in alcohol use interventions in this population but in our experience are the best indicators of long term recovery from psychosis. The symptoms will generally improve with antipsychotic drug treatment but reach a threshold after 6 months in most individuals who engage with our 5 year program. Further functional and social recovery seem to be the best determinants of a full return to health in this population.
详细描述
Our aim is to pilot cognitive enhancement therapy (CET) in EPP individuals with problematic alcohol use, randomizing subjects to either CET or treatment as usual (TAU), which involves brief (1 session) psychoeducation on the impacts of substance use in general on recovery. In addition to examining the impact on clinical metrics, the investigators plan to measure social determinants of health such as return to school or work and resumption of relationships. These variables have not been a focus previously in alcohol use interventions for this population, but in our experience, these measures are the best indicators of long-term functional recovery from psychosis.
This study will collect three different types of variables- demographic (things that describe the participants), clinical (things that describe how ill the individuals are) and substance use (things that measure how much or how reliant participants are on recreational substances).
Demographic variables: Age, sex, gender, ethnicity, highest education level attained and current employment or education status as well as religious status (observing/not observing/do not identify) will be collected at baseline. Employment and school enrollment will be measured again at the end of the intervention.
Clinical variables: Diagnosis will be recorded two ways, first by what the participant's clinician has determined and second for standardization, a Structured Clinical Interview from the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) will be used to give a diagnosis. Several scales will be collected, some of these are collected as part of the patient's standard of care such as the Positive and Negative Syndrome Scale (PANSS) which assesses negative and positive psychotic symptom severity, and the General Assessment of Functioning (GAF) scale which provides a broad measure of patient functioning in the domains of occupational, social and psychological functioning. These measures are collected at multiple time points in the early intervention service for psychosis.
Study specific measures are the World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0), and the Psychological General Well-Being Index (PGWB) will be administered to measure by self-report the domains of anxiety, depression, general health, positive wellbeing, self-control, and vitality, measuring the impact of mental health on well-being.
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)
盲法说明
The psychometrist assessing participant outcomes will not be aware of the participants allocation.
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
- •This study will enroll individuals 16-35 years of age from Early Intervention Services for Psychosis in Nova Scotia
- •less than 5 years of psychotic illness.
- •Individuals will have a psychotic spectrum diagnosis (primary psychotic disorder) that will include schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder.
- •have problematic alcohol use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT))
排除标准
- •presence of another substance use disorder other than nicotine dependence
结局指标
主要结局
Alcohol consumption (mL per day)
时间窗: 6 months
To determine if youth and emerging adults with early phase psychosis and problematic alcohol use (score of 8 or higher on the AUDIT) will reduce alcohol consumption after treatment with a cognitive enhancement therapy intervention. Changes in alcohol consumption will be measured (mL per day).
次要结局
- Feasibility of a shortened intervention(6 months)
- Possible role of gender in alcohol consumption(6 months)
- Engagement based on gender(6 months)