<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/NCT03754829</url>
  </required_header>
  <id_info>
    <org_study_id>No: 53325897-115.02-E.263941</org_study_id>
    <nct_id>NCT03754829</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey</brief_title>
  <official_title>A Randomized Controlled Trial of a Web and Mobile Guided Psychological Intervention for Depressive Symptoms in Turkey.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Burçin Ünlü İnce</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Middle East Technical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VU University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Scientific and Technological Research Council of Turkey</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>
      The aim of this study is to test the clinical effects of a web and mobile application of&#xD;
      guided Problem Solving Therapy for depressive symptoms among the general population in&#xD;
      Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Turkey, there are serious deficiencies in mental health care. Among these, undertreatment&#xD;
      of mentally ill patients, lack of psychologists and inadequate psychosocial and&#xD;
      rehabilitation options for patients and their relatives are important prohibiting factors&#xD;
      that reduce patients' outreach for getting help. While depression is highly prevalent (4.4%),&#xD;
      only a small number of people seek professional help (18%) in Turkey. Innovative solutions&#xD;
      are needed to overcome this treatment gap. Online Problem-Solving Therapy (PST) is a brief&#xD;
      intervention proven to be effective in the treatment of depression, although little is known&#xD;
      about its clinical effects in Turkey.&#xD;
&#xD;
      The aim of this study is to test the clinical effects of a web and mobile application of PST&#xD;
      for depressive symptoms among the general population in Turkey.&#xD;
&#xD;
      Participants will be recruited through announcements in social media and the Middle East&#xD;
      Technical University. A randomized controlled trial with a sample size of 444 participants&#xD;
      randomized across three groups will be utilized. The first experimental group will receive&#xD;
      direct access to the web version of the intervention; the second experimental group will&#xD;
      receive direct access to the mobile app of the intervention as well as automated supportive&#xD;
      text messages based on PST. The control group consists of a wait-list and for ethical&#xD;
      reasons, participants in this group will gain access to the intervention (either web or&#xD;
      mobile application) four months after the baseline. The intervention is based on an existing&#xD;
      PST for the Turkish population, &quot;Her Sey Kontrol Altinda&quot; (HSKA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 19, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A three-armed randomized controlled trial with 2 experimental groups and 1 control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on Beck Depression Inventory-II</measure>
    <time_frame>Screening; baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>Depressive symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>Anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Penn State Worry Questionnaire (PSWQ)</measure>
    <time_frame>baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>The PSWQ will be used to measure pathological worry. It has 16 items in total. Each item can be scored on a five-point scale from 1 (not at all typical of me) to 5 (very typical of me), with a total score varying from 16 to 80. Higher scores indicating greater worry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Perceived Stress Scale (PSS)</measure>
    <time_frame>baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>The PSS will be used to measure the perception of stress. It consists of 10 items for which the total score range is 0-40. Each item is rated on a five-point scale, from 0 (never) to 4 (very often). Higher scores indicating greater stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on General Self-Efficacy Scale (GSE)</measure>
    <time_frame>baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>The GSE is a measure to assess self-efficacy beliefs. It contains 10 items, which are rated on a four-point scale from 1 (not at all true) to 5 (exactly true). The total score varies from 10 to 50. Higher scores indicating greater self-efficacy beliefs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on EuroQol-5D-5L (EQ-5D-5L)</measure>
    <time_frame>baseline, 6-8 weeks after baseline and 4 months after baseline</time_frame>
    <description>EQ-5D-5L will be used to measure quality of life. It consists of 5 items each measuring different dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The items are rated on a five-point scale from level 1 to level 5 (no problems; slight, moderate; severe and extreme problems). All the answers to each item are combined resulting in 3125 possible health states, ranging from 11111 (full health) to 55555 (worst health). Furthermore, there is a visual analogue scale (EQ-VAS) measuring a global rating of self-perceived health. This is scored by 0 (the worst health you can imagine) to 100 (the best health you can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the intervention questionnaire</measure>
    <time_frame>6-8 weeks after baseline only in the two experimental groups</time_frame>
    <description>Participants will be asked about each module to define their satisfaction with the module concerned ('Was this lesson useful to you?'). The answers can be rated on a 5-point Likert scale from 1 (not at all) to 5 (very useful).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MINI-International Neuropsychiatric Interview</measure>
    <time_frame>Screening</time_frame>
    <description>Suicidal ideations</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">444</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>HSKA - Web Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first experimental group will receive direct access to the web version of HSKA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HSKA - Mobile Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Her Sey Kontrol Altinda (HSKA)</intervention_name>
    <description>HSKA consists of 5 sessions over 5 weeks and is based on Problem-Solving therapy. Participants receive feedback on their homework assignments in brief weekly online messages from a clinical psychologist.</description>
    <arm_group_label>HSKA - Mobile Group</arm_group_label>
    <arm_group_label>HSKA - Web Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Turkish participants living in Turkey are eligible if the applicants are aged between&#xD;
             18-55 years and have mild to moderate depressive symptoms (Beck Depression&#xD;
             Inventory-II score between 10 and 29).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded if they have a BDI-II score above 29, or a medium-to-&#xD;
             high suicidal risk (according to the MINI-International Neuropsychiatric Interview)&#xD;
             and are advised to contact a psychiatrist or clinical psychologist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Burçin Ünlü Ince, Ph.D.</last_name>
    <phone>+905307341776</phone>
    <email>unlu_burcin@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Didem Gökçay, Ph.D.</last_name>
    <phone>+90312210 3750</phone>
    <email>dgokcay@metu.edu.tr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Middle East Technical University</name>
      <address>
        <city>Çankaya</city>
        <state>Ankara</state>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Didem Gökçay, Ph.D.</last_name>
      <phone>+903122103750</phone>
      <email>dgokcay@metu.edu.tr</email>
    </contact>
    <contact_backup>
      <last_name>Burçin Ünlü Ince, Ph.D.</last_name>
      <phone>+905307341776</phone>
      <email>unlu_burcin@outlook.com</email>
    </contact_backup>
    <investigator>
      <last_name>Didem Gökçay, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Burçin Ünlü Ince, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Scientific and Technological Research Council of Turkey</investigator_affiliation>
    <investigator_full_name>Burçin Ünlü İnce</investigator_full_name>
    <investigator_title>Ph.D., Postdoctoral Researcher</investigator_title>
  </responsible_party>
  <keyword>Randomized Controlled trial</keyword>
  <keyword>Mobile Application</keyword>
  <keyword>Problem-Solving Therapy</keyword>
  <keyword>Online Guided Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03754829
org study id: No: 53325897-115.02-E.263941
nct id: NCT03754829
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test the clinical effects of a web and mobile application of
      guided Problem Solving Therapy for depressive symptoms among the general population in
      Turkey.
In Turkey, there are serious deficiencies in mental health care. Among these, undertreatment
      of mentally ill patients, lack of psychologists and inadequate psychosocial and
      rehabilitation options for patients and their relatives are important prohibiting factors
      that reduce patients' outreach for getting help. While depression is highly prevalent (4.4%),
      only a small number of people seek professional help (18%) in Turkey. Innovative solutions
      are needed to overcome this treatment gap. Online Problem-Solving Therapy (PST) is a brief
      intervention proven to be effective in the treatment of depression, although little is known
      about its clinical effects in Turkey.

      The aim of this study is to test the clinical effects of a web and mobile application of PST
      for depressive symptoms among the general population in Turkey.

      Participants will be recruited through announcements in social media and the Middle East
      Technical University. A randomized controlled trial with a sample size of 444 participants
      randomized across three groups will be utilized. The first experimental group will receive
      direct access to the web version of the intervention; the second experimental group will
      receive direct access to the mobile app of the intervention as well as automated supportive
      text messages based on PST. The control group consists of a wait-list and for ethical
      reasons, participants in this group will gain access to the intervention (either web or
      mobile application) four months after the baseline. The intervention is based on an existing
      PST for the Turkish population, "Her Sey Kontrol Altinda" (HSKA).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A three-armed randomized controlled trial with 2 experimental groups and 1 control group.
primary purpose: Treatment
masking: Single (Investigator)
measure: Change on Beck Depression Inventory-II
time frame: Screening; baseline, 6-8 weeks after baseline and 4 months after baseline
description: Depressive symptoms
measure: Change on State-Trait Anxiety Inventory (STAI)
time frame: baseline, 6-8 weeks after baseline and 4 months after baseline
description: Anxiety symptoms
measure: Change on Penn State Worry Questionnaire (PSWQ)
time frame: baseline, 6-8 weeks after baseline and 4 months after baseline
description: The PSWQ will be used to measure pathological worry. It has 16 items in total. Each item can be scored on a five-point scale from 1 (not at all typical of me) to 5 (very typical of me), with a total score varying from 16 to 80. Higher scores indicating greater worry.
measure: Change on Perceived Stress Scale (PSS)
time frame: baseline, 6-8 weeks after baseline and 4 months after baseline
description: The PSS will be used to measure the perception of stress. It consists of 10 items for which the total score range is 0-40. Each item is rated on a five-point scale, from 0 (never) to 4 (very often). Higher scores indicating greater stress.
measure: Change on General Self-Efficacy Scale (GSE)
time frame: baseline, 6-8 weeks after baseline and 4 months after baseline
description: The GSE is a measure to assess self-efficacy beliefs. It contains 10 items, which are rated on a four-point scale from 1 (not at all true) to 5 (exactly true). The total score varies from 10 to 50. Higher scores indicating greater self-efficacy beliefs.
measure: Change on EuroQol-5D-5L (EQ-5D-5L)
time frame: baseline, 6-8 weeks after baseline and 4 months after baseline
description: EQ-5D-5L will be used to measure quality of life. It consists of 5 items each measuring different dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The items are rated on a five-point scale from level 1 to level 5 (no problems; slight, moderate; severe and extreme problems). All the answers to each item are combined resulting in 3125 possible health states, ranging from 11111 (full health) to 55555 (worst health). Furthermore, there is a visual analogue scale (EQ-VAS) measuring a global rating of self-perceived health. This is scored by 0 (the worst health you can imagine) to 100 (the best health you can imagine).
measure: Satisfaction with the intervention questionnaire
time frame: 6-8 weeks after baseline only in the two experimental groups
description: Participants will be asked about each module to define their satisfaction with the module concerned ('Was this lesson useful to you?'). The answers can be rated on a 5-point Likert scale from 1 (not at all) to 5 (very useful).
measure: MINI-International Neuropsychiatric Interview
time frame: Screening
description: Suicidal ideations
arm group label: HSKA - Web Group
arm group type: Experimental
description: The first experimental group will receive direct access to the web version of HSKA.
arm group label: HSKA - Mobile Group
arm group type: Experimental
description: The second experimental group will receive direct access to the mobile app of HSKA as well as automated supportive text messages based on PST.
arm group label: Control Group
arm group type: No Intervention
description: The control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline.
intervention type: Behavioral
intervention name: Her Sey Kontrol Altinda (HSKA)
description: HSKA consists of 5 sessions over 5 weeks and is based on Problem-Solving therapy. Participants receive feedback on their homework assignments in brief weekly online messages from a clinical psychologist.
arm group label: HSKA - Mobile Group
arm group label: HSKA - Web Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Burçin Ünlü Ince, Ph.D.
phone: +905307341776
email: unlu_burcin@outlook.com
last name: Didem Gökçay, Ph.D.
phone: +90312210 3750
email: dgokcay@metu.edu.tr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: The Scientific and Technological Research Council of Turkey
investigator full name: Burçin Ünlü İnce
investigator title: Ph.D., Postdoctoral Researcher
mesh term: Depression
sharing ipd: Undecided