Online Transdiagnostic Group Cognitive Behavioural Therapy (CBT) for Postpartum Depression and Anxiety: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of participants recruited in recruitment period
研究概览
简要总结
The purpose of this pilot study is to test the feasibility of an online 10-Week group cognitive behavioural therapy (CBT; a type of talking therapy) intervention for postpartum depression and anxiety that is led by psychotherapists, social workers, a psychologist and/or a psychiatrist. Mothers and birthing parents who are 18 years or older, have an infant under 12 months, living in Ontario and who have postpartum depression and/or anxiety symptoms will be assigned with a 50/50 chance (like flipping a coin) to receive online transdiagnostic group CBT in addition to usual postnatal care, or to receive usual postnatal care only.
详细描述
This study will involve a pilot randomized controlled trial (RCT) to determine the feasibility of a 10-week group CBT intervention for treating postpartum depression and anxiety and study procedures. Primary feasibility objectives include recruitment, completion of study measures, retention and participant satisfaction/acceptability of the intervention. The secondary objective of the pilot RCT is to estimate the treatment effects on PPD and anxiety symptoms to guide the conduct of a future full-scale RCT of the intervention.
48 Participants will be assigned in a 1:1 ratio to the experimental (transdiagnostic CBT group plus treatment as usual (TAU)) or control group (TAU alone). Participants in both groups will complete all study questionnaires at baseline (T1), 10 weeks later (T2 - immediately post-intervention in the experimental group to assess effectiveness), and 6 months after enrollment (T3 - intervention durability). Participants in the treatment group will complete a satisfaction questionnaire with three open-ended questions that will explore their experiences and recommendations for improving the intervention.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
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
- •≥18 years old
- •have an infant <12 months at recruitment
- •fluent in written/spoken English
- •have an EPDS score ≥10 and/or a GAD-7 score≥10
- •live in Ontario, Canada
排除标准
- •does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders
研究组 & 干预措施
10-week Transdiagnostic Group CBT Intervention
The experimental group will receive a 10-week transdiagnostic group CBT intervention delivered by a pair of trained mental health providers (psychiatrists, psychologists, social workers, nurses and/or registered psychotherapists) in addition to receiving treatment as usual.
干预措施: Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety (Behavioral)
Control - usual care
Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.
结局指标
主要结局
Number of participants recruited in recruitment period
时间窗: 6 months
Recruit and randomize 48 participants (over two groups; 24 experimental, 24 control) in six months
Number of participants who complete all data collection procedures
时间窗: 6 months
75% of participants complete all three questionnaires and structured interviews
Number of participants who complete study (retention)
时间窗: 6 months
75% of participants remain in study until completion
Number of participants who complete the intervention (adherence)
时间窗: 6 months
80% of participants in treatment group complete the intervention
次要结局
- Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)(10 weeks)
- Estimate Treatment effect - GAD-7(10 weeks)
研究者
Ryan Van Lieshout, MD, PhD
Professor
McMaster University