Feasibility of a Web-Based Intervention for Women With Postpartum Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Engagement as measured by the total duration of time spent on the web-based intervention
研究概览
简要总结
This study examines the feasibility and acceptability of a web-based intervention program for women with anxiety after childbirth, potential anxiety reduction after the intervention and determines the feasibility of the study design (randomized controlled design) and recruitment for the intervention in this population to inform the protocol (including effect size and study power) for a randomized controlled trial.
详细描述
Background: What Am I Worried About (WAWA) is a self-help booklet intervention for women experiencing anxiety after birth based on cognitive-behavioural and mindfulness principles developed in Australia. The WAWA booklet was found to be acceptable, safe, stigma free, feasible, and demonstrated preliminary efficacy in Australia. A web-based version of WAWA for the use in the United-Kingdom (UK) was developed at City University London in collaboration with the intervention development team in Australia. However, before dissemination the web-based version of WAWA (iWAWA) in the UK it is deemed important to evaluate the program. Therefore, this study aims to examine the feasibility, acceptability, and potential efficacy of this web-based intervention program for women with anxiety after childbirth in the UK.
The primary objectives of the proposed study are to:
conduct a randomized controlled trial and
- examine the feasibility of web-based treatment program (iWAWA) in terms of engagement and usability.
- examine user's acceptability of iWAWA in terms of usefulness, satisfaction, and credibility.
The secondary objectives of this study are to:
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
- None
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
- •Women who are within the first 12 months postpartum (at the beginning of the intervention)
- •Aged over 18
- •Living in England
- •Sufficient knowledge of written and spoken English
- •Access to internet at home
- •Report a score of ≥5 on the Generalized Anxiety Disorder Scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
排除标准
- •Still birth or perinatal death of latest baby
- •Latest baby seriously ill
- •Report self-harm or suicidal ideation
- •Currently receiving formal psychotherapy
研究组 & 干预措施
Web-based intervention
Participants get access to the web-based intervention and are asked to work through the 8 modules of the intervention within eight weeks. The intervention program sends automated weekly email reminders about the current session. In addition, users are offered weekly optional 30-minute telephone support with a trained intervention coach.
干预措施: internet-What Am I Worried About (Behavioral)
Wait-list control
Participants get standard care and will be offered access to the web-based intervention at 8-weeks post-randomization.
结局指标
主要结局
Engagement as measured by the total duration of time spent on the web-based intervention
时间窗: At time of intervention (8 weeks)
Engagement as measured by the time spent on individual pages of the web-based intervention
时间窗: At time of intervention (8 weeks)
Engagement as measured by the number of intervention coach calls
时间窗: At time of intervention (8 weeks)
Usability as measured by participant's report of usefulness ("I found this module useful.") of each intervention module on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree).
时间窗: At time of intervention (8 weeks) after each completed intervention module
Engagement as measured by the duration of intervention coach calls
时间窗: Continuous throughout the 8 week intervention period
Engagement as measured by the number of log-ins into the web-based intervention
时间窗: At time of intervention (8 weeks)
Engagement as measured by the duration of log-ins into the web-based intervention
时间窗: At time of intervention (8 weeks)
Usability as measured by participant's report of clarity ("This module was clear and understandable.") of each intervention module on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree).
时间窗: At time of intervention (8 weeks) after each completed intervention module
Usability as measured by participant's report of usability on the System Usability Scale (SUS)
时间窗: Within 2 weeks after the intervention
The System Usability Scale (SUS) is a 10-item instrument rated on 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and participants are asked to rate the degree to which they agree with positive and negative descriptions of a program. The SUS will be adapted for this study by replacing 'the system/product' with 'iWAWA' for all items. Higher scores indicate better usability.
Usability as measured by participant's report of usability on a series of items designed to measure ease-of-use and unobtrusiveness on 7-point Likert scale (1 = strongly disagree to 7 = strongly agree)
时间窗: Within 2 weeks after the intervention
Usability as measured by participant's report of any technical problems experienced with the intervention website
时间窗: Within 2 weeks after the intervention
Usability as measured by participant's report of interest in future usage of the intervention
时间窗: Within 2 weeks after the intervention
Usefulness as measured by participant's report of a series of items designed to measure perceived usefulness on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree).
时间窗: Within 2 weeks after the intervention
Satisfaction as measured by participant's report of a series of items designed to measure perceived satisfaction on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree).
时间窗: Within 2 weeks after the intervention
Satisfaction as measured by participant's report on the Client Satisfaction Questionnaire (CSQ-8)
时间窗: Within 2 weeks after the intervention
The Client Satisfaction Questionnaire (CSQ-8) will further be used and adapted to assess satisfaction. The CSQ-8 consists of eight items which are rated on 5-point Likert scale. The CSQ-8 will be adapted for this study by substituting 'service' with 'help" and "program" with "iWAWA" in all items.
Credibility as measured by participant's report on the first 4 items of Credibility/ Expectancy Questionnaire (CEQ)
时间窗: Within 2 weeks after the intervention
The Credibility/ Expectancy Questionnaire (CEQ) is a 6-item widely applied measure of the expectancies or perception of intervention credibility and will be adapted for the use in this study.
Usability as measured by participant's report of hypothetical recommendation of the intervention to others.
时间窗: Within 2 weeks after the intervention
Women's perspectives and experiences as measured by semi-structured interviews
时间窗: Within 8 weeks after the intervention
次要结局
- Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)(Within 1 week after the end of the 4 week post-intervention follow-up period)
- Study feasibility as measured by pre-intervention data collection completeness(Within 4 weeks of ending data collection)
- Study feasibility as measured by post-intervention data collection rate(Within 4 weeks of ending data collection)
- Study feasibility as measured by post-intervention data collection completeness(Within 4 weeks of ending data collection)
- Study feasibility as measured by 4 week post intervention follow-up data collection rate(Within 4 weeks of ending data collection)
- Study feasibility as measured by 4 week post intervention follow-up data collection completeness(Within 4 weeks of ending data collection)
- Study feasibility as measured by pre-intervention data collection rate(Within 4 weeks of ending data collection)
- Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)(Within 1 week after the end of the 4 week post-intervention follow-up period)
- Study feasibility as measured by consent rate(Within 4 weeks of ending recruitment)
- Study feasibility as measured by retention rate(Within 4 weeks of ending data collection)
- Study feasibility as measured by recruitment rate(Within 4 weeks of ending recruitment)
- Study feasibility as measured by eligibility rate(Within 4 weeks of ending recruitment)
- Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)(Within 1 week before the intervention)
- Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)(Within 1 week before the intervention)
- Anxiety level as measured by participant's report on the Generalized Anxiety Disorder Scale (GAD-7)(Within 1 week after the intervention)
- Depression, anxiety and stress symptomatology as measured by participant's report on the Depression, Anxiety, and Stress Scale (DASS 21)(Within 1 week after the intervention)