跳至主要内容
临床试验/NCT06035159
NCT06035159招募中不适用

The Feasibility, Usability and Satisfaction of an Online Tool for the Treatment of Anxiety and Depressive Symptoms in the Perinatal Period (From Pregnancy to 1 Year After Delivery)

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2023年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
395
试验地点
2
主要终点
use of the online tool, by means of number of log-ins

研究概览

简要总结

With this study the investigators aim to examine through a mixed method study the feasibility, usability and satisfaction with the developed online tool for perinatal mental health problems. This will be done through a pre- and post measurement of depressive and anxiety symptoms and the use of the tool itself. In addition, a qualitative thematic analysis will be conducted on the clarity, understandability and user-friendliness of the tool.

详细描述

With the development and implementation of an online treatment tool, the existing online offer in Flanders (depression help, suicide) can be extended to pregnant women and women giving birth. This was necessary in the absence of a specific treatment offer for perinatal mental health problems.

In the framework of Project 2.0 of the Flemish Government, an online tool for the treatment of depressive and anxiety symptoms in the perinatal period has been developed by the Center for PMG UZ Gent (Mrs. Rita Van Damme, Prof. Dr. Gilbert Lemmens) in collaboration with the research group of Prof. Dr. Patrick Luyten (KUL). Online interventions have a wide reach, are easily accessible, have a destigmatizing effect and have a preventive function by reducing anxiety and depressive symptoms.

The online tool consists of 6 modules (parenting, relationships, self-care, emotions, cognitions and holding plan). It is recommended to do 1 module per week. The online tool will be launched in cooperation with OnlinePsyHulp, a GGZ group responsible for the website www.depressiehulp.be.

Through a mixed method study, the investigators aim to examine the feasibility, usability and satisfaction of the tool with a pre- and post measurement in preparation for a clinical trial. By means of an online application procedure, we will check whether participants applying to be enrolled in the study meet the inclusion criteria (pregnant woman or woman giving birth, partner of pregnant woman or woman giving birth, depressive or anxiety symptoms, 18 years or older, perinatal period (pregnancy to 1 year after birth), Dutch-speaking, living in Belgium). Participants meeting the inclusion criteria can enroll in the study after providing online informed consent, including email address.

At the start of the online tool, a number of demographic data (age, sex, marital status, education level, ethnicity, number of pregnancies, number of other (living) children, (expected) delivery date, current treatment modalities (medications, psychotherapeutic interventions, other), use of emotional support, psychiatric history) and questionnaires regarding depressive, anxiety and stress symptoms will be completed. These questionnaires, the Depression Anxiety Stress Scale (DASS 21-R) and the Edinburgh Postnatal Depression Scale (EPDS) will be repeated at follow-up (8 weeks after start). The question about other forms of treatment and use of emotional support will also be repeated at follow-up. The participant may receive up to 2 reminder emails (one per week) asking them to still complete these questionnaires after the online therapy. This should allow the researchers to calculate an effect through a pre-post measurement. In addition the investigators would like to conduct a qualitative thematic analysis on the feasibility, usability and satisfaction with the treatment program. This by means of the System Usability Scale (SUS) and 1 qualitative open-ended question on the usability of the tool (2 weeks after last login) and patient satisfaction after each lesson/module and 2 weeks after last login by means of qualitative questions (Likert scale and (open-ended) in-depth questions. When a participant does not log in for 2 weeks, an email is sent asking if they still intend to log in and if not to complete the qualitative questions. After this, a maximum of 1 reminder email may be sent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pregnant or giving birth
  • partner of pregnant/birthing woman
  • depressive or anxiety symptoms,
  • 18 years or older,
  • perinatal period (pregnancy up to 1 year after birth),
  • Dutch-speaking,
  • living in Belgium

排除标准

  • younger than 18 years of age,
  • outside perinatal period,
  • do not speak Dutch well enough,
  • not resident in Belgium.

结局指标

主要结局

use of the online tool, by means of number of log-ins

时间窗: up to 10 weeks

number of log-ins (number)

use of the online tool, by means of number of lesson/modules started

时间窗: up to 10 weeks

number of modules started (number)

patient satisfaction, by means of open-ended qualitative questions, when participant completes the program

时间窗: through study completion, after each module (up to 10 wks)

qualitative questions (open-ended) in-depth questions

patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder

时间窗: 2 weeks

qualitative questions (open-ended) in-depth questions.

use of the online tool, by means of time logged in

时间窗: up to 10 weeks

time spent logged in (minutes)

usability of the online tool, by means of the System Usability Scale (SUS) when participant no longer logs in and after invitation through email reminder

时间窗: 2 weeks

the system usability scale, the SUS, total socre

usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program

时间窗: through study completion, after each module (up to 10 wks)

the system usability scale, the SUS, total score

use of the online tool, by means of number of exercises completed

时间窗: up to 10 weeks

number of exercises completed (number)

usability of the online tool, by means of an open-ended qualitative question when participant completes the program.

时间窗: through study completion, after each module (up to 10 wks)

a qualitative open question

patient satisfaction, by means of qualitative questions when participant completes the program

时间窗: through study completion, after each module (up to 10 wks)

qualitative questions (Likert scale)

usability of the online tool, by means of an open-ended qualitative question, when participant no longer logs in and after invitation through email reminder

时间窗: 2 weeks

a qualitative open question

patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder

时间窗: 2 weeks

qualitative questions (Likert scale)

次要结局

  • reduction of depressive and anxiety symptoms as pre-measurement(baseline)
  • reduction of depressive, and anxiety symptoms as post-measurement(study completion (up to 10 weeks))
  • reduction of depressive, anxiety and stress symptoms as pre-measurement(baseline)
  • reduction of depressive, anxiety and stress symptoms as post-measurement(study completion (up to 10 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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