Cognitive Behavioural Group Therapy for Perinatal Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
研究概览
简要总结
This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a 6-week waitlist condition.
详细描述
Anxiety disorders affect up to 15% of women in the perinatal period (i.e., pregnancy, postpartum) and are a serious mental health concern. Anxiety disorders often coexist with depression and result in high distress and an impaired ability for new mothers to take care of themselves and their babies. In spite of the high prevalence of anxiety disorders during pregnancy and postpartum, research and clinical attention in this area is lacking and no empirically supported psychological treatments exist. Further, since many pregnant or postpartum women are unable or choose not to take medication for their mental health symptoms, establishing an effective non-pharmacological alternative is imperative. Cognitive-behavioural therapy is a well established psychological treatment for anxiety and mood disorders, with moderate to large effect sizes (Cohen's d = 0.5-1.3). The investigators developed a novel group-based cognitive-behavioural treatment program (CBGT) for perinatal women with anxiety disorders. In an initial, single-sample pilot study (Green et al., 2015), a significant reduction in symptoms of anxiety and depression was found from pre to post-treatment, along with reported high levels of treatment satisfaction. The purpose of the current study is to evaluate the effectiveness of this treatment using a larger sample and a randomized controlled trial (RCT).
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
Assessors conducted assessments of symptoms and overall functioning at baseline, 6-weeks post-baseline, and (for participants assigned to CBGT) at 3-months post-treatment. Assessors were unaware of participants' assigned condition.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental
After an initial assessment, the experimental group will receive 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety (n=6 per group) for perinatal anxiety. They will then be re-assessed at post-treatment and 3 months post-treatment to determine the effectiveness of the treatment and whether these effects are maintained 3 months after treatment.
干预措施: Cognitive Behavioural Therapy for Perinatal Anxiety (Other)
Waitlist Control
After an initial assessment, the wait-list control group will not receive any treatment for 6 weeks. They will then be re-assessed after 6 weeks and this data will be used to compare this group to the experimental group to determine the effectiveness of the treatment. After this re-assessment they will be offered the same treatment as the experimental group: 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety
结局指标
主要结局
State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
时间窗: 6 weeks
Changes in anxiety symptoms will be assessed through the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA; Gros et al.,2007) to examine whether CBT for perinatal anxiety 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)(6 weeks)
- Penn State Worry Questionnaire (PSWQ)(6 weeks)
- Intolerance of Uncertainty Scale (IUS-12)(6 weeks)
- Multidimensional Perfectionism Scale (MPS)(6 weeks)
- Multidimensional Parenting Perfectionism Scale (MPPQ)(6 weeks)
- Parenting Sense of Competence Scale (PSOC)(6 weeks)
- Social Provisions Scale (SPS)(6 weeks)
- Abbreviated Dyadic Adjustment Scale (ADAS)(6 weeks)
- Perceived Stress Scale (PSS)(6 weeks)
- Emotion Regulation Questionnaire (ERQ)(6 weeks)
- WHO Disability Assessment Scale 2.0 (WHODAS)(6 weeks)
- Hamilton Anxiety Scale (HAM-A)(6 weeks)
- Montgomery-Asberg Depression Scale (MADRS)(6 weeks)
- Difficulties in Emotion Regulation Scale (DERS-II)(6 weeks)
- Worry Behaviors Inventory (WBI)(6 weeks)
- The Female Sexual Function Index (FSFI)(6 weeks)
- The Sexual Quality of Life - Female (SQoL-F)(6 weeks)
- Client Satisfaction Questionnaire (CSQ)(6 weeks)
- Postpartum Bonding Questionnaire (PBQ)(6 weeks)
研究者
Sheryl Green
Cinical Health Psychologist
St. Joseph's Healthcare Hamilton
