Clinical trial NCT06035159: The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder, Major
Depression, Postpartum
Anxiety
Anxiety Disorders
Pregnancy Related
Keywords: software, psychotherapy, telemedicine
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: OnlinePsyHulp, Belgium
First posted: 2023-09-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Outcome measures are: 1) the reduction of depressive, anxiety and stress symptoms using DASS 21-R and EPDS (the latter to compare with other studies regarding depressive symptoms) after using the tool 2) the use of the online tool (via time logged in, number of logins and number of modules started, number of exercises completed), 3) the feasibility and understandability by the SUS and 1 qualitative open question regarding the usability of the tool 4) the determination of patient satisfaction through qualitative questions (Likert scale and (open-ended) in-depth questions.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: use of the online tool, by means of time logged in
timeFrame: up to 10 weeks
measure: use of the online tool, by means of number of log-ins
timeFrame: up to 10 weeks
measure: use of the online tool, by means of number of lesson/modules started
timeFrame: up to 10 weeks
measure: use of the online tool, by means of number of exercises completed
timeFrame: up to 10 weeks
measure: usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program
timeFrame: through study completion, after each module (up to 10 wks)
measure: 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
timeFrame: 2 weeks
measure: usability of the online tool, by means of an open-ended qualitative question when participant completes the program.
timeFrame: through study completion, after each module (up to 10 wks)
measure: 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
timeFrame: 2 weeks
measure: patient satisfaction, by means of qualitative questions when participant completes the program
timeFrame: through study completion, after each module (up to 10 wks)
measure: patient satisfaction, by means of open-ended qualitative questions, when participant completes the program
timeFrame: through study completion, after each module (up to 10 wks)
measure: patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder
timeFrame: 2 weeks
measure: patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder
timeFrame: 2 weeks
Secondary outcomes:
measure: reduction of depressive, anxiety and stress symptoms as pre-measurement
timeFrame: baseline
measure: reduction of depressive, anxiety and stress symptoms as post-measurement
timeFrame: study completion (up to 10 weeks)
measure: reduction of depressive and anxiety symptoms as pre-measurement
timeFrame: baseline
measure: reduction of depressive, and anxiety symptoms as post-measurement
timeFrame: study completion (up to 10 weeks)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital of Gent
Study officials:
affiliation: University Hospital of Gent - University of Gent
name: Gilbert Lemmens, Prof
role: PRINCIPAL_INVESTIGATOR
References: