Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
研究概览
简要总结
This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, aged 18-45 years
- •Pregnant or up to six months postpartum
- •Primary diagnosis of an anxiety disorder, as per the MINI for DSM-5, with or without comorbid depression
- •No concurrent psychological treatment
- •Not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per Canadian Psychiatric Guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately)
- •Fluent in English in order to understand the consent and group material
排除标准
- •Severe depression/suicidality
- •Primary diagnosis other than an anxiety disorder
- •Psychotic or current substance/alcohol use disorder
结局指标
主要结局
State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
时间窗: 8 weeks
Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(8 weeks)
- Postpartum Bonding Questionnaire (PBQ)(8 weeks)
- Overall Anxiety Severity and Impairment Scale (OASIS)(8 weeks)
- Abbreviated Dyadic Adjustment Scale (ADAS)(8 weeks)
- Perceived Stress Scale (PSS)(8 weeks)
- Intolerance of Uncertainty Scale (IUS)(8 weeks)
- COVID-19 Stress Scales (CSS)(8 weeks)
- Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)(8 weeks)
- Penn State Worry Questionnaire (PSWQ)(8 weeks)
- Parenting Sense of Competence Scale (PSOC)(8 weeks)
- Social Provisions Scale (SPS)(8 weeks)
- Postpartum Specific Anxiety Scale (PSAS)(8 weeks)
- Maternal Antenatal Attachment Scale (MAAS)(8 weeks)
- Client Satisfaction Questionnaire (CSQ)(8 weeks)
研究者
Sheryl Green
Clinical Health Psychologist
St. Joseph's Healthcare Hamilton