Feasibility and Acceptability Study of "Mamá, te Entiendo": an App-based Intervention for Reducing Depressive Symptoms in Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Satisfaction with the intervention
研究概览
简要总结
Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women"
Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745).
General objective: To assess the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Design: A small-scale parallel 2-arms trial will be conducted. Postpartum women with minor or major depression will be randomized to the app-based intervention or waitlist. The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Semi-structured interviews with a sub-sample will provide more information about the participants' experience with the intervention. Women's depression diagnostic status will be assessed at pre-treatment, post-treatment, and 1-month follow-up. Other secondary outcomes will include participants' perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.
详细描述
Background
Chile has a high prevalence of postpartum depression and a significant treatment gap. Some barriers to postpartum depression care uncover the need for more easily accessible and lower-cost interventions. Chile's high utilization of digital technologies across all social strata and the increased use of pregnancy and parenting apps open the possibility of delivering interventions through mobile devices. Cognitive-behavioral internet-based interventions have proven to be effective in reducing symptoms of depression in high-income countries. However, in Chile, this is an underdeveloped field. This trial aims to examine the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.
Methods and design
Study Design
This is a mixed-methods feasibility and acceptability study of an app-based intervention for reducing postpartum depression symptoms. A two-arm, small-scale randomized controlled trial will be conducted with postpartum women with minor or major depression. Women will be randomly assigned to the intervention group (internet-based intervention: "Mamá, te entiendo" /"Mom, I get you") or the control group (waitlist: WL). The three primary data collection points for study participants in the intervention group and WL group are as follows: baseline (pre-treatment: T0), post-treatment (8 weeks from randomization: T1), and 1-month follow-up (12 weeks from randomization: T2). A sample size of 33 participants per group was set. A qualitative evaluation will be conducted to have more knowledge about participants' perspectives on the intervention and study procedures.
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
An independent person not involved in the study will generate the allocation sequence. Stratified randomization will be conducted according to depressive symptom severity. Researchers will be blind to the randomization process and will be notified through email regarding participant allocation by an independent researcher.
Outcome interviews will be conducted by clinical psychologists that will be masked for the condition.
It is not possible to mask personnel and participants to the treatment allocation because of the nature of the intervention.
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 will be included if they:
- •have a < 6-month-old baby,
- •have a PHQ-9 (Kroenke et al., 2001; Diez-Quevedo et al., 2001) score ≥ 5 points,
- •have minor or major depression according to the Mini-International Neuropsychiatric Interview (MINI: Sheehan et al., 1999; Ferrando et al., 2000),
- •are at least 18 years old,
- •are Chilean residents,
- •are fluent in written and spoken Spanish,
- •self-report ownership of a smartphone, and
- •self-report regular access to the internet.
- •Minor depression will be defined as the presence of two to four concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and negative impact on the individual's life (American Psychiatric Association, 2013). Major depression will be defined as the presence of five or more concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and a negative impact on the individual's life (American Psychiatric Association, 2013).
排除标准
- •Participants exclusion criteria will be the following: illiteracy, risk of suicide, alcohol or substance abuse, bipolar disorder, and psychotic disorder.
结局指标
主要结局
Satisfaction with the intervention
时间窗: T1 (post test: 8 weeks)
The Client Satisfaction Questionnaire is used to assess satisfaction with the intervention. It is an 8-item self-report questionnaire that assesses the general level of satisfaction with a service received. The total score ranges from 8 to 32. Higher score indicates greater satisfaction.
Participants' adherence to the intervention
时间窗: T1 (post test: 8 weeks)
Percentage of participants who completed all main modules.
Participants' usability of the intervention
时间窗: T1 (post test: 8 weeks)
Average, range, and standard deviation of the number of main modules completed.
Intervention's acceptability by credibility/expectancy
时间窗: T0: baseline
The CEQ is used to assess treatment credibility and expectancy of benefit. The CEQ is a 6-item self-report questionnaire that measures treatment credibility, defined as "how believable, convincing, and logical the treatment is" and expectancy, defined as "improvements the client believes will be achieved". Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention. Therefore, higher scores mean better outcomes.
Participants' adherence to the homework exercises
时间窗: T1 (post test: 8 weeks)
Average, range, and standard deviation of homework exercises sent to the e-coach.
Engagement with the intervention
时间窗: T1 (post test: 8 weeks)
Engagement with the intervention is assess by the TWEETS. The TWEETS is a 9-item self-report measure that assesses engagement with an eHealth technology. Of the nine items, three are aimed at assessing behavioral engagement, three at cognitive engagement, and three at affective engagement. Each item is measured on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score ranges from 0 to 36. Higher scores indicate greater engagement.
Intervention's acceptability by participant's experience
时间窗: After T2 (follow-up: 12 weeks)
A sub-sample of participants from the intervention group will be invited to participate in semi-structured interviews. The interviews will explore positive and negative impressions and general experiences with the intervention and study procedures. The interviews will be analysed through thematic analysis.
Resources needed to complete the intervention
时间窗: Through the study, in average 8 months
Length of time required for e-coaches to deliver the intervention.
次要结局
- Change in depression diagnosis(T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks))
- Change in depressive symptoms(T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks))
- Change in postpartum depressive symptoms(T0 (Baseline), T1 (post test: 8-weeks) and T2 (follow-up: 12-weeks))
- Change in perceived social support(T0 (Baseline) and T2 (follow-up: 12-weeks))
- Change in mother-infant bonding(T0 (Baseline) and T2 (follow-up: 12-weeks))
- Change in satisfaction and self-efficacy regarding motherhood(T0 (Baseline) and T2 (follow-up: 12-weeks))
- Mental Healthcare Services Use from T0 to T1(T1 (post test: 8-weeks))
- Mental Healthcare Services Use from T1 to T2(T2 (follow-up: 12-weeks))
研究者
Pamela Franco
Principal Investigator
Pontificia Universidad Catolica de Chile