<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/NCT03825562</url>
  </required_header>
  <id_info>
    <org_study_id>Dnro 7U/2015</org_study_id>
    <nct_id>NCT03825562</nct_id>
  </id_info>
  <brief_title>Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes</brief_title>
  <official_title>Acceptance and Value Based Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes / Hyväksyntä- ja Arvopohjaiset menetelmät Diabetesta Sairastavien Nuorten Hyvinvoinnin edistämisessä</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Finland Hospital District</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Jyvaskyla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Diabetes Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Finland Hospital District</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to study how using acceptance and value based group intervention&#xD;
      helps the wellbeing of teenagers with type in diabetes.&#xD;
&#xD;
      The investigators created an ACT-group intervention consisting of five sessions, based on&#xD;
      earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic&#xD;
      are invited to join the groups. The participants are randomized to research and control&#xD;
      groups. The HbA1c-level is monitored for both groups as well as the psychological&#xD;
      flexibility, diabetes related acceptance, depression and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">May 2021</completion_date>
  <primary_completion_date type="Actual">May 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>up to 8 months</time_frame>
    <description>HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by KINDL-r Questionnaire</measure>
    <time_frame>up to 8 months</time_frame>
    <description>To measure the quality of life the Revised Children's Quality of Life Questionnaire is used. The KINDLr is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17 years (Ravens-Sieberer &amp; Bullinger, 1998). In this study, we use the generic, youth-specific, mode of the questionnaire consisting of 24 questions and the diabetes specific module consisting of 17 questions. The answers are given on the Likers Scale from 1-5. The generic mode consists of 6 sub-scales: physical well-being, emotional well-being, self-esteem, social contacts and school. The six sub-scales are combined to form a total score of maximum 120. The maximum score in diabetes specific module is 85. Higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Related Psychological flexibility assessed by DAAS</measure>
    <time_frame>up to 8 months</time_frame>
    <description>To measure diabetes related acceptance skills the DAAS-questionnaire (The Diabetes Acceptance and Action Scale for Children and Adolescents) is used. A questionnaire is developed to measure the diabetes related psychological flexibility (Greco &amp; Hart, 2005). Questionnaire consists of 42 questions and responses are given on Likert scale from 0-4. The maximum score in the questionnaire is 168. The higher sum in the questionnaire refers to higher psychological flexibility, better acceptance of diabetes and action.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms assessed by RBDI</measure>
    <time_frame>up to 8 months</time_frame>
    <description>To measure the depressive symptoms and anxiety the RBDI-questionnaire (Revised Beck Depression Inventory) is used. RBDI is a Finnish version of The Beck Depression Inventory (Beck &amp; Beck, 1972). It consists of 13 questions measuring depressive symptoms and one question measuring anxiety. In each question there are five possible answers to choose and scores are given from 0 to 3. The maximum score for measuring depressive symptoms is 39 and the maximum score for the question measuring anxiety is 3. Higher scores means more symptoms of depression or anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological flexibility assessed by CAMM</measure>
    <time_frame>up to 8 months</time_frame>
    <description>To asses psychological flexibility CAMM (The Child and Adolescent Mindfulness measure) is used. CAMM-questionnaire was developed to measure the mindfulness and acceptance skills and it assesses the degree to which children and adolescents observe internal experiences, act with awareness, and accept internal experiences without judging them (Greco, Baer, &amp; Smith, 2011). The 10-question version is used. The answers are given on Likert scale 0-4, from never true to always true. Maximum score is 40. Higher scores indicate higher levels of mindfulness and acceptance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>research group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group is offered to attend the intervention afterwards</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>acceptance and commitment therapy, ACT</intervention_name>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>research group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  weekly psychiatric appointments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raimo Lappalainen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>supervisor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iina Alho</name>
      <address>
        <city>Jyväskylä</city>
        <zip>40620</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>ACT</keyword>
  <keyword>adolescents</keyword>
  <keyword>value based methods</keyword>
  <keyword>acceptance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT03825562
org study id: Dnro 7U/2015
nct id: NCT03825562
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of the study is to study how using acceptance and value based group intervention
      helps the wellbeing of teenagers with type in diabetes.

      The investigators created an ACT-group intervention consisting of five sessions, based on
      earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic
      are invited to join the groups. The participants are randomized to research and control
      groups. The HbA1c-level is monitored for both groups as well as the psychological
      flexibility, diabetes related acceptance, depression and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Glycemic control
time frame: up to 8 months
description: HbA1c
measure: Quality of life assessed by KINDL-r Questionnaire
time frame: up to 8 months
description: To measure the quality of life the Revised Children's Quality of Life Questionnaire is used. The KINDLr is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17 years (Ravens-Sieberer & Bullinger, 1998). In this study, we use the generic, youth-specific, mode of the questionnaire consisting of 24 questions and the diabetes specific module consisting of 17 questions. The answers are given on the Likers Scale from 1-5. The generic mode consists of 6 sub-scales: physical well-being, emotional well-being, self-esteem, social contacts and school. The six sub-scales are combined to form a total score of maximum 120. The maximum score in diabetes specific module is 85. Higher scores indicate better quality of life.
measure: Diabetes Related Psychological flexibility assessed by DAAS
time frame: up to 8 months
description: To measure diabetes related acceptance skills the DAAS-questionnaire (The Diabetes Acceptance and Action Scale for Children and Adolescents) is used. A questionnaire is developed to measure the diabetes related psychological flexibility (Greco & Hart, 2005). Questionnaire consists of 42 questions and responses are given on Likert scale from 0-4. The maximum score in the questionnaire is 168. The higher sum in the questionnaire refers to higher psychological flexibility, better acceptance of diabetes and action.
measure: Depressive symptoms assessed by RBDI
time frame: up to 8 months
description: To measure the depressive symptoms and anxiety the RBDI-questionnaire (Revised Beck Depression Inventory) is used. RBDI is a Finnish version of The Beck Depression Inventory (Beck & Beck, 1972). It consists of 13 questions measuring depressive symptoms and one question measuring anxiety. In each question there are five possible answers to choose and scores are given from 0 to 3. The maximum score for measuring depressive symptoms is 39 and the maximum score for the question measuring anxiety is 3. Higher scores means more symptoms of depression or anxiety.
measure: Psychological flexibility assessed by CAMM
time frame: up to 8 months
description: To asses psychological flexibility CAMM (The Child and Adolescent Mindfulness measure) is used. CAMM-questionnaire was developed to measure the mindfulness and acceptance skills and it assesses the degree to which children and adolescents observe internal experiences, act with awareness, and accept internal experiences without judging them (Greco, Baer, & Smith, 2011). The 10-question version is used. The answers are given on Likert scale 0-4, from never true to always true. Maximum score is 40. Higher scores indicate higher levels of mindfulness and acceptance.
arm group label: research group
arm group type: Experimental
description: Research group is attending the ACT intervention first and from before and afte measurement are compared to the control group
arm group label: control group
arm group type: Active Comparator
description: Control group is offered to attend the intervention afterwards
intervention type: Behavioral
intervention name: acceptance and commitment therapy, ACT
arm group label: control group
arm group label: research group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
last name: Raimo Lappalainen, PhD
role: Study Director
affiliation: supervisor
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No