A Pilot Randomized Trial of a Telephone Coaching Intervention for Postpartum Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower fertility rates, and longer postpartum hospital stay.
This research study is a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential benefits of a low cost sustainable web-based intervention (WBI) with telephone coaching for women with mild to moderate symptomatology of postpartum depression and anxiety.
The intervention contains modules that will help postpartum mothers:
- Learning new information to better understand their condition. This can help mothers feel that they are not alone, and that their experience is not abnormal. It gives a better understanding that can help them feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
- Learning and practicing new skills. This can help mothers feel confident that they can engage in the behaviours that have been shown to be beneficial for mood and to improve stress. This can include learning to plan activities like physical exercise, practice proper sleep hygiene or learning to use a new way of thinking about problems to help you find solutions.
This trial represents a first step to implement a sustainable intervention for PMH problems in order to better serve women's PMH needs and preferences for support. This will help inform the current gap in low cost web-based interventions for PMH.Specific deliverables (in both French and English) include: a manual detailing coaching procedures; reports for decision makers and short summaries for stakeholder groups
详细描述
Among women who present with symptoms of depression or anxiety within 5 - 12 weeks of giving birth, the following research questions will be considered:
- Feasibility and Acceptability of the two intervention components - WBI and coaching:
a) Among women in the coached and non-coached groups: i) What are participant perceptions of the usability of the WBI with regard to the layout, navigation and functionality at 3 months following randomization? ii) What are the rates of satisfaction with the intervention at 6 months? b) Among women in the coached group: i) What are rates of completion of the planned telephone contacts? ii) What are participant perceptions of the acceptability of the coaching at 6 months? iii) What are coach perceptions of acceptability of coaching intervention? 2. Effectiveness: The EPDS is the primary outcome measure for depression and the GAD-7 is the primary outcome measure for anxiety i) Primary outcomes: What is the effect of coaching on the severity of depression and/or anxiety symptoms at the 3 and 6 month follow-up? ii). Secondary outcomes: What is the effect of coaching at 3 and 6 months on maternal functioning, parental stress and at 6 months on use of mental health services, and barriers to use of these services?
Hypothesis: The investigators expect a decrease in scores in the EPDS and GAD-7 in the group with coaching when compared to the group without coaching at 6 months.
The investigators will conduct a pilot single -blind randomized control trial with lay telephone coaching with two groups of women, one assigned to the WBI with coaching and the other to the self-guided WBI. This RCT would consist of the following steps:
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 (Investigator)
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
- •Age 18+ (at birth)
- •Ability to speak English or French
- •Livebirth
- •Access to the internet and email
- •Inclusion criteria (at step 2):
- •Score on either EPDS 10 - 19 or GAD-7 of 10+. Women with a GAD-7 score of 15+ will be referred to the mental health nurse and will be included in the study.
- •Baby at home
排除标准
- •Women currently undergoing psychological treatment and /or having a history of bipolar disorder or psychosis will be excluded
- •Severe symptoms (Score of 20 or more on the EPDS, will be excluded Any anti-depressant and/or psychological treatment will be managed by the participant's own physician and not by the research team.
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Screening, 3 months & 6 months
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure, with a four point response scale, and is designed to screen participants for depressive symptoms in the last seven days. The EPDS includes one question (Item 10) about thoughts of self-harm. Sum scores for the 10 items are used to generate a total score. This measure has optimal sensitivity and specificity using a cut-off score of 12. For the purposes of this study, a cut off score of 10+ is used to identify participants with potentially clinically significant depressive symptoms . Women who score 20 or over on the EPDS will be excluded and is considered to be in the range of severe symptoms. A score of 10-19 will be included in the study and is considered to be mild to moderate symptoms. An increase in these scores in either category would be consdiered as an increase in symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Screening,3 months & 6 months
The seven-item, self-report Generalized Anxiety Disorder (GAD-7) questionnaire, designed to screen for and measure the level of anxiety symptoms during the last seven days. An identified cut point of 10 is used for this study. Women who have a GAD-7 of greater than 15 will be considered as showing symptoms of anxiety in the severe range. a score of 10 - 15 will be considered mild to moderate symptoms of anxiety.
次要结局
- Barkin Index of Maternal Functioning (BIMF)(Baseline, 3 months & 6 months)
- Coach logs and records(6 months)
- Questions on usability & acceptability(3 months)
- Questionnaire on Use of services for mental health problems(Baseline & 6 months)
- Coach exit interview(6 months)
- Parental Stress Questionnaire (PARSS)(Baseline, 3 months & 6 months)
- Client Satisfaction Questionnaire (CSQ-8)(6 months)
- Acceptability of Coaching Questionnaire(6 months)
研究者
Jane McCusker, MD DrPH
Principal Scientist, St. Mary's Research Centre
McGill University