<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/NCT01706380</url>
  </required_header>
  <id_info>
    <org_study_id>3M Study</org_study_id>
    <nct_id>NCT01706380</nct_id>
  </id_info>
  <brief_title>3M Study - Maria Malmö Mobile Telephone Study</brief_title>
  <official_title>A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study, in an out-patient setting for substance use treatment in adolescents,&#xD;
      examines the effect on treatment retention of a mobile telephone follow-up technique&#xD;
      (interactive voice response), with or without personal feedback. Subjects in treatment for&#xD;
      substance use disorders will be followed by automated mobile telephone contact with questions&#xD;
      about psychiatric symptoms and substance use, and the investigators hypothesize that this&#xD;
      technique, including a personal feedback reporting back to the client whether his or her&#xD;
      status is changing in one way or another, may increase the treatment retention, possibly by&#xD;
      means of an intensified treatment contact.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Retention in substance use disorder treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Duration of retention in treatment and whether the client remains in treatment at 3 months or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in substance use</measure>
    <time_frame>3 months</time_frame>
    <description>Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in psychiatric symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical course with respect to emergency visits</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical course with respect to hospitalizations</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical course with respect to repeated treatment episodes</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Interactive voice response with personal feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interactive voice response without personal feedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interactive voice response with personal feedback</intervention_name>
    <description>Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.</description>
    <arm_group_label>Interactive voice response with personal feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interactive voice response without personal feedback</intervention_name>
    <description>Control condition. Identical follow-up but without personal feedback.</description>
    <arm_group_label>Interactive voice response without personal feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient applying for substance use disorder treatment at out-patient facility Maria&#xD;
             Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not provide written informed consent to the study, or whose&#xD;
             psychiatric condition or language difficulties make it impossible for them to&#xD;
             understand patient information and give informed consent to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden</name>
      <address>
        <city>Malmö</city>
        <state>Skane</state>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Anders C Håkansson</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Substance use disorders</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Retention</keyword>
  <keyword>Mobile telephone</keyword>
  <keyword>Follow-up</keyword>
  <keyword>Interactive voice response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT01706380
org study id: 3M Study
nct id: NCT01706380
lead sponsor: 
has dmc: No
The present study, in an out-patient setting for substance use treatment in adolescents,
      examines the effect on treatment retention of a mobile telephone follow-up technique
      (interactive voice response), with or without personal feedback. Subjects in treatment for
      substance use disorders will be followed by automated mobile telephone contact with questions
      about psychiatric symptoms and substance use, and the investigators hypothesize that this
      technique, including a personal feedback reporting back to the client whether his or her
      status is changing in one way or another, may increase the treatment retention, possibly by
      means of an intensified treatment contact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retention in substance use disorder treatment
time frame: 3 months
description: Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
measure: Improvement in substance use
time frame: 3 months
description: Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?
measure: Improvements in psychiatric symptoms
time frame: 3 months
description: Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?
measure: Clinical course with respect to emergency visits
time frame: 12 months
measure: Clinical course with respect to hospitalizations
time frame: 12 months
measure: Clinical course with respect to repeated treatment episodes
time frame: 12 months
arm group label: Interactive voice response with personal feedback
arm group type: Experimental
description: Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.
arm group label: Interactive voice response without personal feedback
arm group type: Active Comparator
description: This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
intervention type: Behavioral
intervention name: Interactive voice response with personal feedback
description: Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.
arm group label: Interactive voice response with personal feedback
intervention type: Behavioral
intervention name: Interactive voice response without personal feedback
description: Control condition. Identical follow-up but without personal feedback.
arm group label: Interactive voice response without personal feedback
criteria: 
gender: All
minimum age: N/A
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Anders C Håkansson
investigator title: MD, PhD
mesh term: Substance-Related Disorders