<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/NCT01663610</url>
  </required_header>
  <id_info>
    <org_study_id>2012334314</org_study_id>
    <nct_id>NCT01663610</nct_id>
  </id_info>
  <brief_title>Online Course Teachning Adults With ADHD How to Use a Smartphone</brief_title>
  <acronym>VardagsSMART</acronym>
  <official_title>Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial (RCT) to evaluate the effect of an&#xD;
      internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or&#xD;
      struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART)&#xD;
      teach the participants how to use a Smartphone to better organize their everday life and will&#xD;
      be compared to a wait list control group (CONT) that later will recieve the same course&#xD;
      without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be&#xD;
      superior to CONT on ability to organize everyday life and ADHD-symptoms, and that&#xD;
      vardagsSMART will be superior to selfSMART on adherence, understanding and perecived&#xD;
      usefullness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smartphones have a potential to improve the life of individuals who have major problems with&#xD;
      structure and remembrance of everyday tasks. The automation by smartphones of these tasks&#xD;
      away from caregivers to the individual is a process that is both time saving and positive for&#xD;
      the individuals sense of autonomy.&#xD;
&#xD;
      There is too little research to date to say with clarity that smartphones is this tool for&#xD;
      most of the patient group but many patients with ADHD report that a smartphone system for&#xD;
      organisation and remembrance is a key that helps many live a more meaningful life.&#xD;
&#xD;
      The best way to teach these skills has not yet been proven. There is a clear advantage with&#xD;
      teaching courses concerning IT in an online setting since hyperlinks and other texts can be&#xD;
      easily forwarded and the course participants can easily use premade calendars and other&#xD;
      tools. This research will try to determine if this type of online course is helpful for these&#xD;
      patients.&#xD;
&#xD;
      VardagsSMART is an online course which will be compared to a waiting list controll group&#xD;
      (CONT) which weekly records how they manage their ADHD symptoms.&#xD;
&#xD;
      The main purpose of this study is to examine whether the VardagsSMART course have a positive&#xD;
      effect for the patient group. An untreated control group is used to ensure that the effects&#xD;
      are not only due to spontaneous improvement. The control group will afterwards be offered the&#xD;
      course without therapist support (SelfSMART), in order to make a preliminary evaluation of&#xD;
      the importance of therapist support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Change (from baseline) in symptoms of inattention and concentration</measure>
    <time_frame>6 weeks (Post) and 9 months (FU)</time_frame>
    <description>Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in ADHD symptoms</measure>
    <time_frame>6 weeks (Post) and 9 months (FU)</time_frame>
    <description>Adult Self Report Scale (ASRS), Full Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in dialy life function</measure>
    <time_frame>6 weeks (Post) and 9 months (FU)</time_frame>
    <description>Sheehan Disability Scale (SDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in Depression and Anxiety</measure>
    <time_frame>6 weeks (Post) and 9 months (FU)</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change (from baseline) in perecived stress</measure>
    <time_frame>6 weeks (Post) and 9 months (FU)</time_frame>
    <description>Perceived Stress Scale-4 (PSS-4)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment evaluation and usage</measure>
    <time_frame>Post-treatment (6 weeks)</time_frame>
    <description>Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>VardagsSMART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VardagsSMART Internet-based course with therapist support during 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control (CONT)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VardagsSMART</intervention_name>
    <description>VardagsSMART Internet-based course with therapist support during 6 weeks</description>
    <arm_group_label>VardagsSMART</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have problems organizing daily activity measured by more then 17 points on the ASRS&#xD;
             questionaire item 1-4 and 7-11-&#xD;
&#xD;
          -  has acces to a smartphone (android or iphone) with internet acces.&#xD;
&#xD;
          -  at least 18 years&#xD;
&#xD;
          -  speaks, writes and read Swedish&#xD;
&#xD;
          -  can not foresee any practical barriers to participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview.&#xD;
&#xD;
          -  somatic or psychiatric problems that are directly contraindicated or seriously hamper&#xD;
             the implementation of the treatment (eg, psychotic disorders).&#xD;
&#xD;
          -  have severe depression, defined as MADRS-S over 30 or suicidal risk judged by more&#xD;
             than 4 points on the MADRS-S question 9 or according to the structured telephone&#xD;
             assessment.&#xD;
&#xD;
          -  currently undergoing some form of treatment that focuses on reducing symptoms of ADHD.&#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>Viktor Kaldo, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>May 15, 2014</last_update_submitted>
  <last_update_submitted_qc>May 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Viktor Kaldo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01663610
org study id: 2012334314
nct id: NCT01663610
lead sponsor: 
has dmc: No
This study is a randomized controlled trial (RCT) to evaluate the effect of an
      internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or
      struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART)
      teach the participants how to use a Smartphone to better organize their everday life and will
      be compared to a wait list control group (CONT) that later will recieve the same course
      without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be
      superior to CONT on ability to organize everyday life and ADHD-symptoms, and that
      vardagsSMART will be superior to selfSMART on adherence, understanding and perecived
      usefullness.
Smartphones have a potential to improve the life of individuals who have major problems with
      structure and remembrance of everyday tasks. The automation by smartphones of these tasks
      away from caregivers to the individual is a process that is both time saving and positive for
      the individuals sense of autonomy.

      There is too little research to date to say with clarity that smartphones is this tool for
      most of the patient group but many patients with ADHD report that a smartphone system for
      organisation and remembrance is a key that helps many live a more meaningful life.

      The best way to teach these skills has not yet been proven. There is a clear advantage with
      teaching courses concerning IT in an online setting since hyperlinks and other texts can be
      easily forwarded and the course participants can easily use premade calendars and other
      tools. This research will try to determine if this type of online course is helpful for these
      patients.

      VardagsSMART is an online course which will be compared to a waiting list controll group
      (CONT) which weekly records how they manage their ADHD symptoms.

      The main purpose of this study is to examine whether the VardagsSMART course have a positive
      effect for the patient group. An untreated control group is used to ensure that the effects
      are not only due to spontaneous improvement. The control group will afterwards be offered the
      course without therapist support (SelfSMART), in order to make a preliminary evaluation of
      the importance of therapist support.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change (from baseline) in symptoms of inattention and concentration
time frame: 6 weeks (Post) and 9 months (FU)
description: Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)
measure: Change (from baseline) in ADHD symptoms
time frame: 6 weeks (Post) and 9 months (FU)
description: Adult Self Report Scale (ASRS), Full Scale
measure: Change (from baseline) in dialy life function
time frame: 6 weeks (Post) and 9 months (FU)
description: Sheehan Disability Scale (SDS)
measure: Change (from baseline) in Depression and Anxiety
time frame: 6 weeks (Post) and 9 months (FU)
description: Hospital Anxiety and Depression Scale (HADS)
measure: Change (from baseline) in perecived stress
time frame: 6 weeks (Post) and 9 months (FU)
description: Perceived Stress Scale-4 (PSS-4)
measure: Treatment evaluation and usage
time frame: Post-treatment (6 weeks)
description: Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.
arm group label: VardagsSMART
arm group type: Experimental
description: VardagsSMART Internet-based course with therapist support during 6 weeks
arm group label: Wait List Control (CONT)
arm group type: No Intervention
description: Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)
intervention type: Behavioral
intervention name: VardagsSMART
description: VardagsSMART Internet-based course with therapist support during 6 weeks
arm group label: VardagsSMART
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Viktor Kaldo, Ph.D
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Viktor Kaldo
investigator title: Principal Investigator
mesh term: Attention Deficit Disorder with Hyperactivity