Depressione-PMGNCT06035159
The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems
A study testing online psychotherapy in people with Depression and Depressive Disorder, Major, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Major, Depression, Postpartum
- What is being tested?
- online psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jul 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 18 years of age,
- outside perinatal period,
- do not speak Dutch well enough,
- not resident in Belgium.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Depression, Depressive Disorder, Major, Depression, Postpartum, Anxiety, Anxiety Disorders, Pregnancy Related
- Being tested
- online psychotherapy
- Keywords
- software, psychotherapy, telemedicine
- Medical subject headings
- Depression, Depressive Disorder, Major, Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online psychotherapyBehavioural
6 modules
| Study group | Role | What they receive |
|---|---|---|
| online psychotherapy | Other | 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. Receives: Behavioral: online psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of the online tool, by means of time logged in
time spent logged in (minutes)
Measured: up to 10 weeks
use of the online tool, by means of number of log-ins
number of log-ins (number)
Measured: up to 10 weeks
use of the online tool, by means of number of lesson/modules started
number of modules started (number)
Measured: up to 10 weeks
use of the online tool, by means of number of exercises completed
number of exercises completed (number)
Measured: up to 10 weeks
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
Measured: through study completion, after each module (up to 10 wks)
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
Measured: 2 weeks
usability of the online tool, by means of an open-ended qualitative question when participant completes the program.
a qualitative open question
Measured: through study completion, after each module (up to 10 wks)
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
Measured: 2 weeks
patient satisfaction, by means of qualitative questions when participant completes the program
qualitative questions (Likert scale)
Measured: through study completion, after each module (up to 10 wks)
patient satisfaction, by means of open-ended qualitative questions, when participant completes the program
qualitative questions (open-ended) in-depth questions
Measured: through study completion, after each module (up to 10 wks)
patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder
qualitative questions (Likert scale)
Measured: 2 weeks
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.
Measured: 2 weeks
Secondary outcomes (4)
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.
Measured: baseline
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.
Measured: study completion (up to 10 weeks)
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)
Measured: baseline
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)
Measured: study completion (up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start10 Jul 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- OnlinePsyHulp, Belgium
- Responsible party
- Sponsor
- Investigators
- Gilbert Lemmens, Prof, Principal investigator, University Hospital of Gent - University of Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035159
- Sponsor's protocol ID
- ONZ-2022-0386
- Acronym
- e-PMG
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06035159
- Acronym / sponsor ID
- e-PMG / ONZ-2022-0386
- Conditions
- Depression, Depressive Disorder, Major, Depression, Postpartum, Anxiety, Anxiety Disorders, Pregnancy Related
- Keywords
- software, psychotherapy, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- OnlinePsyHulp, Belgium
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| online psychotherapy | Other | Behavioral: online psychotherapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (4 listed)
- younger than 18 years of age,
- outside perinatal period,
- do not speak Dutch well enough,
- not resident in Belgium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online psychotherapy6 modules | Behavioural | online psychotherapy |
Primary outcome
use of the online tool, by means of time logged in
Time frame: up to 10 weeks
time spent logged in (minutes)
use of the online tool, by means of number of log-ins
Time frame: up to 10 weeks
number of log-ins (number)
use of the online tool, by means of number of lesson/modules started
Time frame: up to 10 weeks
number of modules started (number)
use of the online tool, by means of number of exercises completed
Time frame: up to 10 weeks
number of exercises completed (number)
usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program
Time frame: through study completion, after each module (up to 10 wks)
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
Time frame: 2 weeks
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.
Time frame: through study completion, after each module (up to 10 wks)
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
Time frame: 2 weeks
a qualitative open question
patient satisfaction, by means of qualitative questions when participant completes the program
Time frame: through study completion, after each module (up to 10 wks)
qualitative questions (Likert scale)
patient satisfaction, by means of open-ended qualitative questions, when participant completes the program
Time frame: through study completion, after each module (up to 10 wks)
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
Time frame: 2 weeks
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
Time frame: 2 weeks
qualitative questions (open-ended) in-depth questions.
4 secondary outcomes
reduction of depressive, anxiety and stress symptoms as pre-measurement
Time frame: baseline
reduction of depressive, anxiety and stress symptoms as post-measurement
Time frame: study completion (up to 10 weeks)
reduction of depressive and anxiety symptoms as pre-measurement
Time frame: baseline
reduction of depressive, and anxiety symptoms as post-measurement
Time frame: study completion (up to 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- online psychotherapy toolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Lemmens, Prof principal investigator
University Hospital of Gent - University of Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online psychotherapy in people with Depression and Depressive Disorder, Major, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of the online tool, by means of time logged in (time frame: up to 10 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.