Evaluating a Self-Directed Cognitive Behavioural Therapy E-Health and M-Health Program for Anxiety in Pregnancy and Postpartum During COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Perinatal Anxiety Symptoms from Baseline
研究概览
简要总结
The pregnancy and postpartum periods can be joyous times in life; however, they can also be filled with challenging physical, emotional, and lifestyle changes. These changes may lead to feelings of stress, anxiety, and depression amongst new and expecting mothers, which can have negative effects on fetal and infant development (Beijers et al., 2010; Goodman et al., 2016). The impacts of increased worry about health and safety due to COVID-19 as well as future-related uncertainties, paired with social (physical) distancing, may be felt especially strongly in this population. Of concern, pregnant and postpartum women have low rates of mental health service use even prior to the pandemic (Fonseca et al., 2015). E-health (Internet) and m-health (mobile application) psychological interventions are accessible, available at reduced cost, and can be accessed within users' homes, a factor that is particularly important during the pandemic (Andrews & Titov, 2010). In this study, the investigators will disseminate a free, online, self-directed Cognitive Behavioural Therapy program to women experiencing symptoms of anxiety during pregnancy and postpartum. This program has shown to be effective at improving symptoms of anxiety and depression when delivered in an in-person group format, and has high acceptability (Furer & Reynolds, 2015). The investigators will transfer this program into an online format so that pregnant and postpartum users can navigate the sessions on their own, without the support of a clinician. This program contains six modules which include topics such as coping with negative thoughts, unpacking the myth of the supermom, and managing expectations during pregnancy and postpartum. Additionally, material related to COVID-19 has been added to the program to target any pandemic-related stress participants may be experiencing. The investigators will collect information about the program's feasibility, acceptability, and effectiveness, which will inform future improvements to the program. This program is expected to reduce participants' feelings of stress, anxiety, and depression, in addition to improving maternal attachment. It is anticipated that these gains will be maintained when the investigators follow-up with participants one month after program completion. This program has the potential to provide accessible and affordable mental health services to pregnant and postpartum women struggling during the pandemic.
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
The research team (principal investigator, co-investigators, research coordinator, and research assistants) will be blinded during the randomization process. To protect participants' identifying information throughout the study, a non-team member will generate a randomized list of unique participant IDs prior to starting recruitment. The non-team member will then randomly assign these IDs to the online self-directed program or waitlist conditions, and will black out this information to conceal it from the research team. The research coordinator will assign participants to a participant ID when they are enrolled in our study. After participants complete their second screening interview (clinical symptom interview), the research coordinator will access the blacked-out information and reveal the participant's condition. Once revealed, this information may be viewed by all members of the research team.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant or within 12 months postpartum
- •Age 18 or older
- •Experiencing symptoms of anxiety
- •Have access to a computer, tablet, or smartphone
- •Have access to the Internet
- •Speak English
- •Manitoba resident
- •Willing to provide their name, email address, home address, and phone number
排除标准
- •Current substance use disorder
- •Diagnoses of bipolar disorder or schizophrenia
- •Current suicidality
结局指标
主要结局
Change in Perinatal Anxiety Symptoms from Baseline
时间窗: The online self-directed program condition will complete it at weeks 1, 6, and 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16. Both conditions will complete the short version weekly during the program.
To assess changes in perinatal anxiety symptoms throughout the study, the Perinatal Anxiety Screening Scale (PASS; Somerville et al., 2014) will be administered. The PASS is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. The scale has excellent reliability, adequate test-retest reliability, and strong evidence of convergent validity (Somerville et al., 2014). A shortened version of the PASS will be administered to participants in both conditions when they are completing the online program. This measure will help determine the effectiveness of this program.
次要结局
- Change in Perinatal Depression Symptoms from Baseline(The online self-directed program condition will complete it at weeks 1, 6, and 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16. Both conditions will complete it weekly during the program.)
- Change in Maternal Antenatal Attachment from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.)
- Change in Maternal Efficacy from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.)
- Acceptability of the Online Self-Directed Program(The TAAS will be administered to the online self-directed program condition at week 2 and the waitlist condition at week 7.)
- Change in Life Stress from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.)
- Change in Non-Specific Psychological Distress from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12 and 16.)
- Change in COVID-19 Stress from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.)
- Change in Maternal Postnatal Attachment from Baseline(The online self-directed program condition will complete it at weeks 1, 6, 10, while the waitlist condition will complete it at weeks 1, 6, 12, and 16.)
- Participant Satisfaction with the Online Self-Directed Program(This measure will be administered to the online self-directed program condition at program completion (week 6) and to the waitlist condition at program completion (week 12).)
- Participant Experiences in the Online Self-Directed Program(The weekly feedback measure will be administered weekly during the program (online self-directed program condition: weeks 1-6; waitlist condition: weeks 6-12). The interview will take place at week 6.)
研究者
Kristin Reynolds
Assistant Professor
University of Manitoba