Group Cognitive Behaviour 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
- 72
- 试验地点
- 2
- 主要终点
- Changes in scores on the Perinatal Anxiety Screening Scale
研究概览
简要总结
Our previous pilot study (N = 40) suggested that group Cognitive Behaviour Therapy for perinatal anxiety (CBT-PA) significantly reduces symptoms of anxiety and depression from pre- to post- intervention. CBT-PA is based on the general principles of CBT but specific themes and examples are geared towards pregnancy and postpartum periods. The 6-week treatment protocol addresses: (1) understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. This intervention and all assessment interviews will be conducted via a hospital-approved video-conferencing platform. All assessment questionnaires will be completed on SurveyGizmo. The objectives of the present study are: (1) to replicate these findings of the pilot study in a larger sample (N = 58) in a randomized controlled trial (RCT), (2) compare the effectiveness of CBT-PA to a control treatment (waitlist control), (3) evaluate the durability of treatment gains at 1-month and 3-months after the conclusion of treatment, (4) evaluate patient preferences in terms of the relevance and the acceptability of the CBT-PA protocol, (5) examine whether the degree of childbirth stress impacts patient response to CBT-PA to inform future refinements to the treatment, and (6) determine whether CBT-PA improves maternal efficacy and attachment with baby. This research is being conducted because many women suffer from perinatal anxiety and have difficulty accessing services in a timely manner. It is the hope that the findings of this study will have clinical significance in terms of providing additional support for CBT as an effective treatment for perinatal anxiety. It is the hope that this treatment will have mental and physical health benefits for the mothers directly, as well as mental and physical health benefits to their fetuses and infants.
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
- •Adult over the age of 18 years living in the province of Manitoba, Canada.
- •Must be pregnant or within 12 months postpartum.
- •Women must also meet criteria for at least one anxiety disorder or related disorder (i.e., generalized anxiety disorder, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder).
排除标准
- •Primary perinatal depression
- •Active suicidality and/or homicidality
- •Active psychosis, manic, or a substance use disorder that would interfere with participation in treatment.
- •Women also must not be receiving concurrent psychotherapy
- •If on medication, must not have made any medication changes in the 6 weeks prior to beginning participation in our study.
研究组 & 干预措施
Group CBT for Perinatal Anxiety
Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety.
干预措施: Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA) (Behavioral)
Waitlist Control
This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment.
干预措施: No treatment (waitlist control) (Other)
结局指标
主要结局
Changes in scores on the Perinatal Anxiety Screening Scale
时间窗: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks
This is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. Scores on this measure can range from 0 to 93, with higher scores indicating higher levels of anxiety. It will be used in the current investigation to examine changes in anxiety symptoms across time.
Change in scores on the Perceived Stress Scale
时间窗: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks
This is a 10-item self-report measure that assesses the extent to which one's life is appraised as stressful. Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.
次要结局
- Change in scores on the The Edinburgh Postnatal Depression Scale(Pre-treatment (intake assessment), immediately post-treatment; 1-month follow-up; 3-month follow-up; and weekly during treatment, up to 6 weeks)
- Change in scores on the Maternal Postnatal Attachment Scale(Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up)
- Post-Delivery Perceived Stress Inventory(Pre-treatment (intake assessment))
- Change in scores on the Maternal Antenatal Attachment Scale(Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up)
- Change in scores on the Maternal Efficacy Questionnaire(Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up)
- The Treatment Acceptability/Adherence Scale(Pre-treatment (at the outset of treatment))
- The Treatment Satisfaction Measure(Immediately post-treatment)
- Change in scores on the The Hamilton Anxiety Rating Scale(Pre-treatment; immediately post-treatment; 1-month post-treatment; 3-months post-treatment)
- The Homework Checklist(From group treatment session two, up to five weeks.)
- The Coronavirus Stressor Survey(Pre-treatment (intake assessment))
- The Treatment Protocol Adherence Checklist(Completed by group leaders weekly, up to 6 weeks.)
研究者
Gillian Alcolado
Assistant Professor
University of Manitoba