Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 216
- 主要终点
- State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
研究概览
简要总结
Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Women 18 and older that are pregnant or between 0-12 months postpartum;
- •Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
- •No concurrent psychological treatment;
- •Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
- •Fluent in English, minimal grade 8 reading level.
排除标准
- •Severe depression/suicidality requiring acute intervention;
- •Women with psychotic or current substance use disorders,
- •medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).
研究组 & 干预措施
Psychoeducation Group
Psychoeducation is the most commonly offered non-pharmacological treatment for perinatal distress, with the assumption that an understanding of perinatal distress, self-care and infant milestones will improve mental health outcomes. Psychoeducation has been shown to be effective in reducing the severity of perinatal anxiety and depression.
干预措施: Psychoeducation (Behavioral)
Cognitive Behavioural Group Therapy
Cognitive Behavioural Group Therapy (CBGT) is a well-established psychological treatment for anxiety and other mental health disorders. CBGT treatment for perinatal anxiety has shown significant reductions in anxiety (primary outcome), worry and depression from pre- to post-treatment when compared to a waitlist control condition. However, to be considered well-established, a treatment must be at least as effective as other active interventions. As such, the present study will compare CBGT to what is most commonly offered to perinatal women with a principal anxiety disorder (i.e., psychoeducation).
干预措施: Cognitive Behavioural Group Therapy (Behavioral)
结局指标
主要结局
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
时间窗: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.
次要结局
- Penn State Worry Questionnaire (PSWQ)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Generalized Anxiety Disorder 7 (GAD-7)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Edinburgh Postnatal Depression Scale (EPDS)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Worry Behaviors Inventory Perinatal Revised (WBI-P)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Intolerance of Uncertainty Scale (IUS)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Perceived Stress Scale (PSS).(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Difficulties in Emotion Regulation Scale (DERS)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Insomnia Severity Index (ISI).(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Anxiety Sensitivity Index (ASI-3)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Abbreviated Dyadic Adjustment Scale (ADAS)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Social Provisions Scale (SPS)(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Illness Intrusiveness Rating Scale (IIRS).(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- World Health Organization Quality of Life Scale (WHOQoL-BREF).(Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.)
- Client Satisfaction Questionnaire (CSQ)(One week post-treatment)
研究者
Sheryl Green
Associate Professor, Clinical Psychologist
St. Joseph's Healthcare Hamilton