<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/NCT02256293</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00040489</org_study_id>
    <nct_id>NCT02256293</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management</brief_title>
  <official_title>Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals with diabetes often report that difficult thoughts and feelings about diabetes&#xD;
      interfere with making healthy choices with regards to diabetes management. The purpose of&#xD;
      this study is to evaluate a diabetes self-management group based on Acceptance and Commitment&#xD;
      Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating&#xD;
      psychological and behavioral difficulties. We are interested in whether individuals with&#xD;
      diabetes will like an ACT-based diabetes management group and whether they find the group&#xD;
      helpful.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the current study is to assess the acceptability and feasibility of an&#xD;
      acceptance-based group to improve diabetes self-management among individuals with Type 1&#xD;
      Diabetes. Interested individuals will participate in a weekly acceptance-based therapy group&#xD;
      focusing on improving diabetes management (e.g., adherence to dietary recommendations,&#xD;
      appropriate insulin dosing) for a total of 8 weeks. Participants will also be asked to&#xD;
      complete questionnaires both pre and post treatment. Questionnaires will assess diabetes&#xD;
      management and acceptability of the group (post treatment only). Regular medical monitoring&#xD;
      is required for participation in the current study. Participants will be asked to provide&#xD;
      consent to contact their current medical provider in order to confirm that the participant's&#xD;
      is receiving regular medical monitoring for diabetes care and that providers are aware of&#xD;
      their patient's participation in group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2015</start_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>8 weeks</time_frame>
    <description>Acceptability of treatment as measured by a post-intervention questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes self-management</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes in diabetes self-management as measured by pre and post-intervention questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Group Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).</intervention_name>
    <description>The group sessions will be lead by a clinician trained in Acceptance and Commitment Therapy and will meet at Duke Medical Center for 1 ½ hours once a week for a total of 8 weeks. During group sessions, participants will identify how avoidance of difficult thoughts and feelings about diabetes has interfered with diabetes management and learn alternative ways of coping with these experiences. The group sessions are intended to supplement regular medical treatment; thus it is important that subjects continue to have diabetes symptoms monitored by their current treatment provider.</description>
    <arm_group_label>Group Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Diagnosed with type 1 diabetes&#xD;
&#xD;
          -  Currently monitored by a physician for their diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or history of psychosis or mania&#xD;
&#xD;
          -  Current substance abuse&#xD;
&#xD;
          -  Non-English Speaking&#xD;
&#xD;
          -  Deficits in intellectual functioning that preclude informed consent&#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>Rhonda Merwin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>June 11, 2015</last_update_submitted>
  <last_update_submitted_qc>June 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</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>
  <!-- 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/NCT02256293
org study id: Pro00040489
nct id: NCT02256293
lead sponsor: 
has dmc: No
Individuals with diabetes often report that difficult thoughts and feelings about diabetes
      interfere with making healthy choices with regards to diabetes management. The purpose of
      this study is to evaluate a diabetes self-management group based on Acceptance and Commitment
      Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating
      psychological and behavioral difficulties. We are interested in whether individuals with
      diabetes will like an ACT-based diabetes management group and whether they find the group
      helpful.
The goal of the current study is to assess the acceptability and feasibility of an
      acceptance-based group to improve diabetes self-management among individuals with Type 1
      Diabetes. Interested individuals will participate in a weekly acceptance-based therapy group
      focusing on improving diabetes management (e.g., adherence to dietary recommendations,
      appropriate insulin dosing) for a total of 8 weeks. Participants will also be asked to
      complete questionnaires both pre and post treatment. Questionnaires will assess diabetes
      management and acceptability of the group (post treatment only). Regular medical monitoring
      is required for participation in the current study. Participants will be asked to provide
      consent to contact their current medical provider in order to confirm that the participant's
      is receiving regular medical monitoring for diabetes care and that providers are aware of
      their patient's participation in group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability
time frame: 8 weeks
description: Acceptability of treatment as measured by a post-intervention questionnaire.
measure: Diabetes self-management
time frame: 8 weeks
description: Changes in diabetes self-management as measured by pre and post-intervention questionnaires.
arm group label: Group Therapy
arm group type: Experimental
description: Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
intervention type: Behavioral
intervention name: Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).
description: The group sessions will be lead by a clinician trained in Acceptance and Commitment Therapy and will meet at Duke Medical Center for 1 ½ hours once a week for a total of 8 weeks. During group sessions, participants will identify how avoidance of difficult thoughts and feelings about diabetes has interfered with diabetes management and learn alternative ways of coping with these experiences. The group sessions are intended to supplement regular medical treatment; thus it is important that subjects continue to have diabetes symptoms monitored by their current treatment provider.
arm group label: Group Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rhonda Merwin, PhD
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1