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The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems (e-PMG)

Primary Purpose

Depression, Depressive Disorder, Major, Depression, Postpartum

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
online psychotherapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring software, psychotherapy, telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital of GentRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

online psychotherapy

Arm Description

All participants have access to the psychotherapeutic intervention, which consists of 6 modules. Initially, we want to get information about the feasibility, comprehensibility and satisfaction of the participants with the tool. Secondly, the effectiveness of the intervention will be assessed through a pre-post measurement.

Outcomes

Primary Outcome Measures

use of the online tool, by means of time logged in
time spent logged in (minutes)
use of the online tool, by means of number of log-ins
number of log-ins (number)
use of the online tool, by means of number of lesson/modules started
number of modules started (number)
use of the online tool, by means of number of exercises completed
number of exercises completed (number)
usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program
the system usability scale, the SUS, total score
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
the system usability scale, the SUS, total socre
usability of the online tool, by means of an open-ended qualitative question when participant completes the program.
a qualitative open question
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
a qualitative open question
patient satisfaction, by means of qualitative questions when participant completes the program
qualitative questions (Likert scale)
patient satisfaction, by means of open-ended qualitative questions, when participant completes the program
qualitative questions (open-ended) in-depth questions
patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder
qualitative questions (Likert scale)
patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder
qualitative questions (open-ended) in-depth questions.

Secondary Outcome Measures

reduction of depressive, anxiety and stress symptoms as pre-measurement
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder.
reduction of depressive, anxiety and stress symptoms as post-measurement
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder.
reduction of depressive and anxiety symptoms as pre-measurement
EPDS, total score (continuous and cut-off >= 13); EDS-3A(3 anxiety questions) (continuous and cut-off >= 5)
reduction of depressive, and anxiety symptoms as post-measurement
EPDS total score (continuous and cut-off >= 13); EDS-3A (3 anxiety questions)(continuous and cut-off >= 5)

Full Information

First Posted
July 26, 2023
Last Updated
September 5, 2023
Sponsor
University Hospital, Ghent
Collaborators
OnlinePsyHulp, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT06035159
Brief Title
The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems
Acronym
e-PMG
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
OnlinePsyHulp, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Major, Depression, Postpartum, Anxiety, Anxiety Disorders, Pregnancy Related
Keywords
software, psychotherapy, telemedicine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
395 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
online psychotherapy
Arm Type
Other
Arm Description
All participants have access to the psychotherapeutic intervention, which consists of 6 modules. Initially, we want to get information about the feasibility, comprehensibility and satisfaction of the participants with the tool. Secondly, the effectiveness of the intervention will be assessed through a pre-post measurement.
Intervention Type
Behavioral
Intervention Name(s)
online psychotherapy
Intervention Description
6 modules
Primary Outcome Measure Information:
Title
use of the online tool, by means of time logged in
Description
time spent logged in (minutes)
Time Frame
up to 10 weeks
Title
use of the online tool, by means of number of log-ins
Description
number of log-ins (number)
Time Frame
up to 10 weeks
Title
use of the online tool, by means of number of lesson/modules started
Description
number of modules started (number)
Time Frame
up to 10 weeks
Title
use of the online tool, by means of number of exercises completed
Description
number of exercises completed (number)
Time Frame
up to 10 weeks
Title
usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program
Description
the system usability scale, the SUS, total score
Time Frame
through study completion, after each module (up to 10 wks)
Title
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
Description
the system usability scale, the SUS, total socre
Time Frame
2 weeks
Title
usability of the online tool, by means of an open-ended qualitative question when participant completes the program.
Description
a qualitative open question
Time Frame
through study completion, after each module (up to 10 wks)
Title
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
Description
a qualitative open question
Time Frame
2 weeks
Title
patient satisfaction, by means of qualitative questions when participant completes the program
Description
qualitative questions (Likert scale)
Time Frame
through study completion, after each module (up to 10 wks)
Title
patient satisfaction, by means of open-ended qualitative questions, when participant completes the program
Description
qualitative questions (open-ended) in-depth questions
Time Frame
through study completion, after each module (up to 10 wks)
Title
patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder
Description
qualitative questions (Likert scale)
Time Frame
2 weeks
Title
patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder
Description
qualitative questions (open-ended) in-depth questions.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
reduction of depressive, anxiety and stress symptoms as pre-measurement
Description
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder.
Time Frame
baseline
Title
reduction of depressive, anxiety and stress symptoms as post-measurement
Description
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder.
Time Frame
study completion (up to 10 weeks)
Title
reduction of depressive and anxiety symptoms as pre-measurement
Description
EPDS, total score (continuous and cut-off >= 13); EDS-3A(3 anxiety questions) (continuous and cut-off >= 5)
Time Frame
baseline
Title
reduction of depressive, and anxiety symptoms as post-measurement
Description
EPDS total score (continuous and cut-off >= 13); EDS-3A (3 anxiety questions)(continuous and cut-off >= 5)
Time Frame
study completion (up to 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Van Damme, phd-stduent
Phone
+32 9 471 207350
Email
rita.vandamme@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Descheemaeker, master
Phone
+32 471 302511
Email
mathilde.desceemaeker@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Lemmens, Prof
Organizational Affiliation
University Hospital of Gent - University of Gent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Van Damme
Phone
+32471207350
Email
rita.vandamme@uzgent.be
First Name & Middle Initial & Last Name & Degree
Mathilde Descheemaeker
Phone
+32471302511
Email
mathilde.descheemaeker@uzgent.be

12. IPD Sharing Statement

Links:
URL
http://depressiehulp.be/zelfhulp/zwangerschap
Description
online psychotherapy tool

Learn more about this trial

The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems

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