xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035159</url>
    </required_header>
    <id_info>
      <org_study_id>ONZ-2022-0386</org_study_id>
      <nct_id>NCT06035159</nct_id>
    </id_info>
    <brief_title>The Feasibility, Usability and Satisfaction of an Online Tool for Perinatal Mental Health Problems</brief_title>
    <acronym>e-PMG</acronym>
    <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)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Ghent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>OnlinePsyHulp, Belgium</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Ghent</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With this study the investigators aim to examine through a mixed method study the&#xD;
        feasibility, usability and satisfaction with the developed online tool for perinatal mental&#xD;
        health problems. This will be done through a pre- and post measurement of depressive and&#xD;
        anxiety symptoms and the use of the tool itself. In addition, a qualitative thematic analysis&#xD;
        will be conducted on the clarity, understandability and user-friendliness of the tool.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With the development and implementation of an online treatment tool, the existing online&#xD;
        offer in Flanders (depression help, suicide) can be extended to pregnant women and women&#xD;
        giving birth. This was necessary in the absence of a specific treatment offer for perinatal&#xD;
        mental health problems.&#xD;
  &#xD;
        In the framework of Project 2.0 of the Flemish Government, an online tool for the treatment&#xD;
        of depressive and anxiety symptoms in the perinatal period has been developed by the Center&#xD;
        for PMG UZ Gent (Mrs. Rita Van Damme, Prof. Dr. Gilbert Lemmens) in collaboration with the&#xD;
        research group of Prof. Dr. Patrick Luyten (KUL). Online interventions have a wide reach, are&#xD;
        easily accessible, have a destigmatizing effect and have a preventive function by reducing&#xD;
        anxiety and depressive symptoms.&#xD;
  &#xD;
        The online tool consists of 6 modules (parenting, relationships, self-care, emotions,&#xD;
        cognitions and holding plan). It is recommended to do 1 module per week. The online tool will&#xD;
        be launched in cooperation with OnlinePsyHulp, a GGZ group responsible for the website&#xD;
        www.depressiehulp.be.&#xD;
  &#xD;
        Through a mixed method study, the investigators aim to examine the feasibility, usability and&#xD;
        satisfaction of the tool with a pre- and post measurement in preparation for a clinical&#xD;
        trial. By means of an online application procedure, we will check whether participants&#xD;
        applying to be enrolled in the study meet the inclusion criteria (pregnant woman or woman&#xD;
        giving birth, partner of pregnant woman or woman giving birth, depressive or anxiety&#xD;
        symptoms, 18 years or older, perinatal period (pregnancy to 1 year after birth),&#xD;
        Dutch-speaking, living in Belgium). Participants meeting the inclusion criteria can enroll in&#xD;
        the study after providing online informed consent, including email address.&#xD;
  &#xD;
        At the start of the online tool, a number of demographic data (age, sex, marital status,&#xD;
        education level, ethnicity, number of pregnancies, number of other (living) children,&#xD;
        (expected) delivery date, current treatment modalities (medications, psychotherapeutic&#xD;
        interventions, other), use of emotional support, psychiatric history) and questionnaires&#xD;
        regarding depressive, anxiety and stress symptoms will be completed. These questionnaires,&#xD;
        the Depression Anxiety Stress Scale (DASS 21-R) and the Edinburgh Postnatal Depression Scale&#xD;
        (EPDS) will be repeated at follow-up (8 weeks after start). The question about other forms of&#xD;
        treatment and use of emotional support will also be repeated at follow-up. The participant&#xD;
        may receive up to 2 reminder emails (one per week) asking them to still complete these&#xD;
        questionnaires after the online therapy. This should allow the researchers to calculate an&#xD;
        effect through a pre-post measurement. In addition the investigators would like to conduct a&#xD;
        qualitative thematic analysis on the feasibility, usability and satisfaction with the&#xD;
        treatment program. This by means of the System Usability Scale (SUS) and 1 qualitative&#xD;
        open-ended question on the usability of the tool (2 weeks after last login) and patient&#xD;
        satisfaction after each lesson/module and 2 weeks after last login by means of qualitative&#xD;
        questions (Likert scale and (open-ended) in-depth questions. When a participant does not log&#xD;
        in for 2 weeks, an email is sent asking if they still intend to log in and if not to complete&#xD;
        the qualitative questions. After this, a maximum of 1 reminder email may be sent.&#xD;
  &#xD;
        Outcome measures are: 1) the reduction of depressive, anxiety and stress symptoms using DASS&#xD;
        21-R and EPDS (the latter to compare with other studies regarding depressive symptoms) after&#xD;
        using the tool 2) the use of the online tool (via time logged in, number of logins and number&#xD;
        of modules started, number of exercises completed), 3) the feasibility and understandability&#xD;
        by the SUS and 1 qualitative open question regarding the usability of the tool 4) the&#xD;
        determination of patient satisfaction through qualitative questions (Likert scale and&#xD;
        (open-ended) in-depth questions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>use of the online tool, by means of time logged in</measure>
      <time_frame>up to 10 weeks</time_frame>
      <description>time spent logged in (minutes)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>use of the online tool, by means of number of log-ins</measure>
      <time_frame>up to 10 weeks</time_frame>
      <description>number of log-ins (number)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>use of the online tool, by means of number of lesson/modules started</measure>
      <time_frame>up to 10 weeks</time_frame>
      <description>number of modules started (number)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>use of the online tool, by means of number of exercises completed</measure>
      <time_frame>up to 10 weeks</time_frame>
      <description>number of exercises completed (number)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program</measure>
      <time_frame>through study completion, after each module (up to 10 wks)</time_frame>
      <description>the system usability scale, the SUS, total score</description>
    </primary_outcome>
    <primary_outcome>
      <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</measure>
      <time_frame>2 weeks</time_frame>
      <description>the system usability scale, the SUS, total socre</description>
    </primary_outcome>
    <primary_outcome>
      <measure>usability of the online tool, by means of an open-ended qualitative question when participant completes the program.</measure>
      <time_frame>through study completion, after each module (up to 10 wks)</time_frame>
      <description>a qualitative open question</description>
    </primary_outcome>
    <primary_outcome>
      <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</measure>
      <time_frame>2 weeks</time_frame>
      <description>a qualitative open question</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patient satisfaction, by means of qualitative questions when participant completes the program</measure>
      <time_frame>through study completion, after each module (up to 10 wks)</time_frame>
      <description>qualitative questions (Likert scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patient satisfaction, by means of open-ended qualitative questions, when participant completes the program</measure>
      <time_frame>through study completion, after each module (up to 10 wks)</time_frame>
      <description>qualitative questions (open-ended) in-depth questions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder</measure>
      <time_frame>2 weeks</time_frame>
      <description>qualitative questions (Likert scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder</measure>
      <time_frame>2 weeks</time_frame>
      <description>qualitative questions (open-ended) in-depth questions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reduction of depressive, anxiety and stress symptoms as pre-measurement</measure>
      <time_frame>baseline</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>reduction of depressive, anxiety and stress symptoms as post-measurement</measure>
      <time_frame>study completion (up to 10 weeks)</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>reduction of depressive and anxiety symptoms as pre-measurement</measure>
      <time_frame>baseline</time_frame>
      <description>EPDS, total score (continuous and cut-off &gt;= 13); EDS-3A(3 anxiety questions) (continuous and cut-off &gt;= 5)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>reduction of depressive, and anxiety symptoms as post-measurement</measure>
      <time_frame>study completion (up to 10 weeks)</time_frame>
      <description>EPDS total score (continuous and cut-off &gt;= 13); EDS-3A (3 anxiety questions)(continuous and cut-off &gt;= 5)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">395</enrollment>
    <condition>Depression</condition>
    <condition>Depressive Disorder, Major</condition>
    <condition>Depression, Postpartum</condition>
    <condition>Anxiety</condition>
    <condition>Anxiety Disorders</condition>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>online psychotherapy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>online psychotherapy</intervention_name>
      <description>6 modules</description>
      <arm_group_label>online psychotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pregnant or giving birth&#xD;
  &#xD;
            -  partner of pregnant/birthing woman&#xD;
  &#xD;
            -  depressive or anxiety symptoms,&#xD;
  &#xD;
            -  18 years or older,&#xD;
  &#xD;
            -  perinatal period (pregnancy up to 1 year after birth),&#xD;
  &#xD;
            -  Dutch-speaking,&#xD;
  &#xD;
            -  living in Belgium&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  younger than 18 years of age,&#xD;
  &#xD;
            -  outside perinatal period,&#xD;
  &#xD;
            -  do not speak Dutch well enough,&#xD;
  &#xD;
            -  not resident in Belgium.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gilbert Lemmens, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Gent - University of Gent</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rita Van Damme, phd-stduent</last_name>
      <phone>+32 9 471 207350</phone>
      <email>rita.vandamme@uzgent.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mathilde Descheemaeker, master</last_name>
      <phone>+32 471 302511</phone>
      <email>mathilde.desceemaeker@uzgent.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital of Gent</name>
        <address>
          <city>Gent</city>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rita Van Damme</last_name>
        <phone>+32471207350</phone>
        <email>rita.vandamme@uzgent.be</email>
      </contact>
      <contact_backup>
        <last_name>Mathilde Descheemaeker</last_name>
        <phone>+32471302511</phone>
        <email>mathilde.descheemaeker@uzgent.be</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <link>
      <url>http://depressiehulp.be/zelfhulp/zwangerschap</url>
      <description>online psychotherapy tool</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>software, psychotherapy, telemedicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression, Postpartum</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035159
  org study id: ONZ-2022-0386
  nct id: NCT06035159
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: use of the online tool, by means of time logged in
  time frame: up to 10 weeks
  description: time spent logged in (minutes)
  measure: use of the online tool, by means of number of log-ins
  time frame: up to 10 weeks
  description: number of log-ins (number)
  measure: use of the online tool, by means of number of lesson/modules started
  time frame: up to 10 weeks
  description: number of modules started (number)
  measure: use of the online tool, by means of number of exercises completed
  time frame: up to 10 weeks
  description: number of exercises completed (number)
  measure: 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)
  description: the system usability scale, the SUS, total score
  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
  time frame: 2 weeks
  description: the system usability scale, the SUS, total socre
  measure: 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)
  description: a qualitative open question
  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
  time frame: 2 weeks
  description: a qualitative open question
  measure: patient satisfaction, by means of qualitative questions when participant completes the program
  time frame: through study completion, after each module (up to 10 wks)
  description: qualitative questions (Likert scale)
  measure: 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)
  description: qualitative questions (open-ended) in-depth questions
  measure: patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder
  time frame: 2 weeks
  description: qualitative questions (Likert scale)
  measure: 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
  description: qualitative questions (open-ended) in-depth questions.
  measure: reduction of depressive, anxiety and stress symptoms as pre-measurement
  time frame: baseline
  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.
  measure: reduction of depressive, anxiety and stress symptoms as post-measurement
  time frame: study completion (up to 10 weeks)
  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.
  measure: reduction of depressive and anxiety symptoms as pre-measurement
  time frame: baseline
  description: EPDS, total score (continuous and cut-off >= 13); EDS-3A(3 anxiety questions) (continuous and cut-off >= 5)
  measure: reduction of depressive, and anxiety symptoms as post-measurement
  time frame: study completion (up to 10 weeks)
  description: EPDS total score (continuous and cut-off >= 13); EDS-3A (3 anxiety questions)(continuous and cut-off >= 5)
  arm group label: online psychotherapy
  arm group type: Other
  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: online psychotherapy
  description: 6 modules
  arm group label: online psychotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gilbert Lemmens, Prof
  role: Principal Investigator
  affiliation: University Hospital of Gent - University of Gent
  last name: Rita Van Damme, phd-stduent
  phone: +32 9 471 207350
  email: rita.vandamme@uzgent.be
  last name: Mathilde Descheemaeker, master
  phone: +32 471 302511
  email: mathilde.desceemaeker@uzgent.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Belgium
  url: http://depressiehulp.be/zelfhulp/zwangerschap
  description: online psychotherapy tool
  responsible party type: Sponsor
  mesh term: Depression, Postpartum
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  mesh term: Depressive Disorder, Major