Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- The Scale for Assessment of Negative Symptoms (SANS)
研究概览
简要总结
Recent research has suggested that mindfulness-based interventions for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and quality of life. However these findings are based on small studies that largely consist of patients with chronic illness. Little is yet known about the use of mindfulness interventions for young people recovering from their first episode of psychosis.
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, is an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. Although the current study is hypothesis generating in nature, based on previous investigations of Mindfulness Based Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC intervention will result in improvements in clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will prove to be acceptable to participants and a feasible intervention for early psychotic disorders.
详细描述
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group mindfulness based intervention specifically designed to promote mindfulness skills and the development of emotional and social competencies in youth, is an effective, feasible, and acceptable means of treating people in the early stages of psychotic illnesses.
We intend to randomly assign 30 patients being treated for psychotic illnesses in an early intervention program to an immediate treatment intervention or a delayed treatment intervention. Participants assigned to the immediate treatment intervention will receive the MAC intervention at the onset of the study whereas those assigned to the delay treatment intervention will receive the MAC intervention after approximately 3 months in a treatment as usual control group.
Participants will be evaluated at baseline, immediately post-intervention and at 3-month post-intervention on a number measures. MAC acceptability will be assessed through the Client Satisfaction Questionnaire and qualitative interviews, MAC feasibility will be assessed through recruitment, consent and completion rates, and MAC efficacy will be assessed with a number of clinical, social, cognitive, and mindfulness skill assessment tools as well as through changes in healthcare utilization before and after administration of the MAC intervention.
Although the current study is hypothesis generating in nature, based on previous findings of Mindfulness Based Interventions for psychoses, we are expecting that participation in the MAC intervention will result in improvements on clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will be acceptable to participants and a feasible intervention for early psychotic disorders.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must currently be in treatment at the Prevention and Early Intervention Program for Psychosis (PEPP) for psychosis. In addition, participants must have been involved in the program for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be between the ages of 18 and 30 years old. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the MAC intervention and complete the assessment tools.
排除标准
- •Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
结局指标
主要结局
The Scale for Assessment of Negative Symptoms (SANS)
时间窗: Baseline, Change from Baseline in SANS at 3 months, change from baseline in SANS at 6 months
The Social Functioning Scale (SFS)
时间窗: Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS)
时间窗: Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months
Kentucky Inventory of Mindfulness Skills (KIMS)
时间窗: Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months
Controlled Oral Word Association Task (COWAT)
时间窗: Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months
Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP)
时间窗: Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months
Health Care Utilization Records Post-Intervention
时间窗: Utilization during the 6 months following the mindfulness intervention
Rosenberg Self-Esteem Scale (RSES)
时间窗: Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months
Theory of Mind Task (TOMT)
时间窗: Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
Digit Symbol Coding Task (DSCT)
时间窗: Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
Hopkins Verbal Learning Task Revised (HVLT)
时间窗: Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months
The Scale for Assessment of Positive Symptoms (SAPS)
时间窗: Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months
The Profile of Mood States - Short Form (POMS)
时间窗: Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months
Health Care Utilization Records Pre-Intervention
时间窗: Utilization during the 6 months prior to the mindfulness intervention
Client Satisfaction Questionnaire - 8 Items (CSQ)
时间窗: Immediately Post-Intervention
Social Interaction Anxiety Scale (SIAS)
时间窗: Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months
Stroop Colour and Word Test (STROOP)
时间窗: Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months
Wechsler Digit Span Subtest (WDS)
时间窗: Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
Qualitative Focus-group
时间窗: Immediately Post-Intervention
次要结局
未报告次要终点
研究者
Arlene MacDougall
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's