<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/NCT03785912</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01059</org_study_id>
    <nct_id>NCT03785912</nct_id>
  </id_info>
  <brief_title>SelFIT: Internet-based Treatment for Adjustment Problems After an Accident</brief_title>
  <acronym>SelFIT</acronym>
  <official_title>Randomized Controlled Trial (RCT) to Evaluate the Efficacy and Cost-effectiveness of an Internet-based Self-help Program for People With Adjustment Problems After an Accident</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Accident Insurance Fund SUVA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, people who suffer from adjustment problems after having experienced an&#xD;
      accident will be randomized to one of two study groups. The first group receives access to&#xD;
      the internet-based self-help intervention immediately. The second group is a waiting control&#xD;
      group that receives access to the program 12 weeks later. In both conditions additional care&#xD;
      or treatment is allowed. The aim of the study is to investigate the efficacy and&#xD;
      cost-effectiveness of an internet-based self-help intervention for people with adjustment&#xD;
      problems after an accident compared to a waiting list. There are 6 assessments, which all&#xD;
      take place online: baseline, two between-measurements (after 4 and 8 weeks), post assessment&#xD;
      (after 12 weeks) and two follow-up assessments (after 3 and 6 months). All participants from&#xD;
      both groups are asked to fill out all assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2019</start_date>
  <completion_date type="Actual">November 28, 2021</completion_date>
  <primary_completion_date type="Actual">November 28, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DASS-21: Depression, Angst, Stress-Skala (Lovibond &amp; Lovibond, 1995)</measure>
    <time_frame>7 minutes</time_frame>
    <description>21-item questionnaire assessing depression, anxiety and stress symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf &amp; Ehlers, 1998)</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>21-item questionnaire assessing depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)</measure>
    <time_frame>6 minutes</time_frame>
    <description>20-item questionnaire assessing adjustment disorder symptoms and severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12: Short Form Health Survey (Ware et al., 1996)</measure>
    <time_frame>5 minutes</time_frame>
    <description>12-item questionnaire assessing various aspects of well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)</measure>
    <time_frame>3 minutes</time_frame>
    <description>10-item questionnaire assessing optimism and pessimism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BVI: Berner Verbitterungsinventar (Znoj, 2008)</measure>
    <time_frame>3 minutes</time_frame>
    <description>18-item questionnaire assessing embitterment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)</measure>
    <time_frame>5 minutes</time_frame>
    <description>24-item questionnaire assessing different aspects of work- and health-related topics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)</measure>
    <time_frame>20 minutes</time_frame>
    <description>58-item questionnaire assessing costs related to an accident</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ZUF-8: Zufriedenheitsfragebogen (Attkisson &amp; Zwick, 1982)</measure>
    <time_frame>2 minutes</time_frame>
    <description>8-item questionnaire assessing content with an online-program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SUS: System Usability Scale (Brooke, 1996)</measure>
    <time_frame>3 minutes</time_frame>
    <description>10-item questionnaire assessing usability of an online-program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem &amp; Schwarzer, 2003)</measure>
    <time_frame>3 minutes</time_frame>
    <description>10-item questionnaire assessing general self-efficacy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Adjustment Impairment</condition>
  <condition>Accident</condition>
  <condition>Adjustment Disorders</condition>
  <condition>Mental Disorder</condition>
  <arm_group>
    <arm_group_label>Internet-based self-help</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The self-help program consists of eight text- and video-based modules. All participants in this group receive immediate access to the self-help program. The program's self-management approach does not provide for regular support from a specialist. However, participants can contact the study team if they need or want additional help.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Access to internet-based intervention after 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based self-help</intervention_name>
    <description>Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.</description>
    <arm_group_label>Internet-based self-help</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: All participants must...&#xD;
&#xD;
          -  be at least 18 years old&#xD;
&#xD;
          -  give a declaration of consent to participate in the study&#xD;
&#xD;
          -  have access to the Internet&#xD;
&#xD;
          -  understand and master the German language to the degree that they understand the&#xD;
             contents and instructions of the study&#xD;
&#xD;
          -  exceed the cut-off value for at least a mild psychological burden on the&#xD;
             depression-anxiety stress scale (DASS- 21)&#xD;
&#xD;
          -  be able to specify an emergency address in the event of an acute crisis&#xD;
&#xD;
          -  have experienced and can specify an accident during a period of two weeks to two years&#xD;
             prior to participation in the current study that lead to the conditions described&#xD;
             above.&#xD;
&#xD;
        Exclusion Criteria: Excluded are persons who...&#xD;
&#xD;
          -  show severe depressive symptoms (Beck depression inventory [BDI-II] &gt; 29)&#xD;
&#xD;
          -  show suicidal tendencies (BDI-II Suicide item &gt; 1)&#xD;
&#xD;
          -  have a known diagnosis of psychotic or bipolar disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hansjörg Znoj, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Berger, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universität Bern</name>
      <address>
        <city>Bern</city>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Adjustment Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03785912
org study id: 2018-01059
nct id: NCT03785912
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, people who suffer from adjustment problems after having experienced an
      accident will be randomized to one of two study groups. The first group receives access to
      the internet-based self-help intervention immediately. The second group is a waiting control
      group that receives access to the program 12 weeks later. In both conditions additional care
      or treatment is allowed. The aim of the study is to investigate the efficacy and
      cost-effectiveness of an internet-based self-help intervention for people with adjustment
      problems after an accident compared to a waiting list. There are 6 assessments, which all
      take place online: baseline, two between-measurements (after 4 and 8 weeks), post assessment
      (after 12 weeks) and two follow-up assessments (after 3 and 6 months). All participants from
      both groups are asked to fill out all assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
time frame: 7 minutes
description: 21-item questionnaire assessing depression, anxiety and stress symptoms
measure: BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)
time frame: 5-10 minutes
description: 21-item questionnaire assessing depressive symptoms
measure: ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)
time frame: 6 minutes
description: 20-item questionnaire assessing adjustment disorder symptoms and severity
measure: SF-12: Short Form Health Survey (Ware et al., 1996)
time frame: 5 minutes
description: 12-item questionnaire assessing various aspects of well-being
measure: LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
time frame: 3 minutes
description: 10-item questionnaire assessing optimism and pessimism
measure: BVI: Berner Verbitterungsinventar (Znoj, 2008)
time frame: 3 minutes
description: 18-item questionnaire assessing embitterment
measure: FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)
time frame: 5 minutes
description: 24-item questionnaire assessing different aspects of work- and health-related topics
measure: TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)
time frame: 20 minutes
description: 58-item questionnaire assessing costs related to an accident
measure: ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
time frame: 2 minutes
description: 8-item questionnaire assessing content with an online-program
measure: SUS: System Usability Scale (Brooke, 1996)
time frame: 3 minutes
description: 10-item questionnaire assessing usability of an online-program
measure: SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
time frame: 3 minutes
description: 10-item questionnaire assessing general self-efficacy
arm group label: Internet-based self-help
arm group type: Experimental
description: The self-help program consists of eight text- and video-based modules. All participants in this group receive immediate access to the self-help program. The program's self-management approach does not provide for regular support from a specialist. However, participants can contact the study team if they need or want additional help.
arm group label: Waiting control group
arm group type: No Intervention
description: Access to internet-based intervention after 12 weeks.
intervention type: Behavioral
intervention name: Internet-based self-help
description: Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.
arm group label: Internet-based self-help
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hansjörg Znoj, Prof. Dr.
role: Study Director
affiliation: University of Bern
last name: Thomas Berger, Prof. Dr.
role: Principal Investigator
affiliation: University of Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Mental Disorders
mesh term: Adjustment Disorders
sharing ipd: No