Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
研究概览
简要总结
Postpartum anxiety (PPA) affects up to 20% of mothers in the first year after delivery, with mothers often reporting both psychological and physical symptoms. Present non-pharmacological interventions are effective at improving some psychological aspects of PPA such as anxiety, depressive mood, and distress. However, current interventions are not effective in improving emotion regulation (ER), something that many with PPA experience impairment in. Current interventions also seldom target the physical aspects of anxiety, such as bodily awareness - sensing and understanding internal signals in the body (e.g., sensing a fast heartbeat). There is a link between ER and bodily awareness, however psychological interventions that target both these aspects have not been investigated in the PPA population. As a result, a mind-body intervention targeting both ER and bodily awareness is needed to offer a more holistic treatment option.
The purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily awareness in those with PPA. We will use self-report questionnaires alongside brain imaging (functional magnetic resonance imaging; fMRI) to evaluate the effectiveness. Combining both subjective and objective measures will provide greater confidence in our findings, ensuring a more comprehensive understanding of the intervention's impact. Self-report questionnaires will be administered at enrolment, immediately post-intervention, and 4 weeks post-intervention. Brain imaging will be conducted at enrolment and immediately post-intervention. We believe this intervention will lead to improvements in anxiety symptoms, ER, and bodily awareness on the questionnaires and fMRI scans.
If effective, the proposed mindfulness intervention will target a broader range of psychological and physical symptoms, and reduce the negative impact of PPA on mothers and their infants in Canada and beyond.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •mothers/birthing parents 18 years and older who are between 0-12 months postpartum
- •principal diagnosis of an anxiety disorder as per the Diagnostic Assessment Research Tool (DART; Schneider et al., 2022), 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; McQueen et al., 2016) 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 alcohol or substance use disorders
- •suffering from severe claustrophobia
- •metallic objects in body (metal implants, pacemakers)
- •currently pregnant
研究组 & 干预措施
4-week mindfulness intervention
干预措施: 4-week mindfulness-based intervention (Behavioral)
Waitlist treatment as usual control
结局指标
主要结局
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
时间窗: Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Difficulties in Emotion Regulation Scale (DERS)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Penn State Worry Questionnaire (PSWQ)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Generalized Anxiety Disorder 7-Item Scale (GAD-7)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- World Health Organization Quality of Life Scale (WHOQoL)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Perceived Stress Scale (PSS)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Interoceptive Sensitivity and Attention Questionnaire (ISAQ)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Postpartum Bonding Questionnaire (PBQ)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- Social Provisions Scale (SPS)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
- The Dyadic Adjustment Scale (DAS)(Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).)
研究者
Sheryl Green
Dr. Sheryl Green, Ph.D., C.Psych
St. Joseph's Healthcare Hamilton