<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/NCT01714986</url>
  </required_header>
  <id_info>
    <org_study_id>FoU-Kronoberg 4522</org_study_id>
    <nct_id>NCT01714986</nct_id>
  </id_info>
  <brief_title>Psychological Variables and Hyperglycemia in Diabetes Mellitus</brief_title>
  <acronym>ALEXIDIAB</acronym>
  <official_title>Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FoU Kronoberg, Landstinget Kronoberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to try the psycho educational method &quot;The Affect School with Script&#xD;
      Analysis and the physiotherapeutic mind-body therapy &quot;Basal Body Awareness Therapy in&#xD;
      patients with diabetes, high HbA1c and psychological symptoms, in order to improve&#xD;
      psychological health- with the primary outcome reduced depression. Secondary outcomes are&#xD;
      improved improved glycemic control and self-image, and reduced alexithymia and anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Depression is common in patients with diabetes and is associated with impaired glycemic&#xD;
      control and elevated cortisol levels. Alexithymia has been associated with depression,&#xD;
      anxiety, stress related disorders and diabetes mellitus. Affect School (AS) is an&#xD;
      intervention that may reduce depression and alexithymia according to previous research. Basic&#xD;
      Body Awareness Therapy (BBAT) is a stress-reducing technique and is used in psychiatric care&#xD;
      in Scandinavia in order to improve psychiatric health.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
      The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality&#xD;
      variables alexithymia and self image in diabetes patients at baseline. 2. Explore&#xD;
      correlations between these variables and risk factors, including biochemical markers for&#xD;
      diabetic complications. 3. To evaluate an intervention with Affect School with Script&#xD;
      Analysis and Basal Body Awareness Therapy in patients with diabetes that scored high in&#xD;
      psychometric self-report tests and at the same time showed impaired metabolic control.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      A randomized controlled trial in two steps. First step started in 2009 and consists of 350&#xD;
      people with diabetes, 90% with type 1 diabetes, 18-59 years, 56% men, 44% women. Base-line&#xD;
      study: from medical records and the National Diabetes Registry - waist circumference, BMI,&#xD;
      blood pressure, type and duration of diabetes, diabetes complications, other diseases,&#xD;
      medications, exercise habits and smoking. Tests - A1c, blood lipids, cytokines, hormones,&#xD;
      beta-cell antibodies, c-peptide, midnight cortisol (salivary). Self-report tests of&#xD;
      psychological and personality variables: HAD, TAS-20, SASB. Intervention: patients with HbA1c&#xD;
      &gt;70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image&#xD;
      (SASB: Affinity dimension &lt;284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA.&#xD;
      AS: 8 group sessions followed by 10 individual sessions. Instructors were a primary care&#xD;
      physician and a psychotherapist. BBA: 10 group meetings and 5individual sessions with a&#xD;
      physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.&#xD;
&#xD;
      Second step will start in 2015: Recruitment of 350 people from primary care with type 2&#xD;
      diabetes with high A1c and either depression, alexithymia, negative self image or anxiety.&#xD;
      Randomization procedures and patient characteristics will be assessed in the same way as&#xD;
      above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not active&#xD;
  </why_stopped>
  <start_date>March 2009</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c</measure>
    <time_frame>First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline</time_frame>
    <description>a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of HbA1c</measure>
    <time_frame>First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline</time_frame>
    <description>Compare the HbA1c level before and after intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alexithymia</measure>
    <time_frame>First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline</time_frame>
    <description>Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline</time_frame>
    <description>Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-image</measure>
    <time_frame>First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline</time_frame>
    <description>Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Depression</condition>
  <condition>Alexithymia</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Affect School</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Psychological group education intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Body Awareness Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physiotherapeutic psychosomatic intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Affect School</intervention_name>
    <arm_group_label>Affect School</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Body Awareness Therapy</intervention_name>
    <arm_group_label>Body Awareness Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c &gt;70 mmol/mol, and&#xD;
             one of the following: depression, alexithymia, anxiety or a negative self image.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be&#xD;
        difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure,&#xD;
        deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe&#xD;
        personality disorder or severe substance abuse), 3) cognitive deficiencies (mental&#xD;
        retardation, stroke or dementia); or 5) inadequate Swedish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva O Melin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fou Kronoberg, Kronoberg County Council, Växjö, Sweden</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Alexithymia</keyword>
  <keyword>Self Image</keyword>
  <keyword>HbA1c</keyword>
  <keyword>Psychoeducation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Affective Symptoms</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/NCT01714986
org study id: FoU-Kronoberg 4522
nct id: NCT01714986
lead sponsor: 
collaborator: 
has dmc: No
The investigators want to try the psycho educational method "The Affect School with Script
      Analysis and the physiotherapeutic mind-body therapy "Basal Body Awareness Therapy in
      patients with diabetes, high HbA1c and psychological symptoms, in order to improve
      psychological health- with the primary outcome reduced depression. Secondary outcomes are
      improved improved glycemic control and self-image, and reduced alexithymia and anxiety.
Background:

      Depression is common in patients with diabetes and is associated with impaired glycemic
      control and elevated cortisol levels. Alexithymia has been associated with depression,
      anxiety, stress related disorders and diabetes mellitus. Affect School (AS) is an
      intervention that may reduce depression and alexithymia according to previous research. Basic
      Body Awareness Therapy (BBAT) is a stress-reducing technique and is used in psychiatric care
      in Scandinavia in order to improve psychiatric health.

      Purpose:

      The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality
      variables alexithymia and self image in diabetes patients at baseline. 2. Explore
      correlations between these variables and risk factors, including biochemical markers for
      diabetic complications. 3. To evaluate an intervention with Affect School with Script
      Analysis and Basal Body Awareness Therapy in patients with diabetes that scored high in
      psychometric self-report tests and at the same time showed impaired metabolic control.

      Method:

      A randomized controlled trial in two steps. First step started in 2009 and consists of 350
      people with diabetes, 90% with type 1 diabetes, 18-59 years, 56% men, 44% women. Base-line
      study: from medical records and the National Diabetes Registry - waist circumference, BMI,
      blood pressure, type and duration of diabetes, diabetes complications, other diseases,
      medications, exercise habits and smoking. Tests - A1c, blood lipids, cytokines, hormones,
      beta-cell antibodies, c-peptide, midnight cortisol (salivary). Self-report tests of
      psychological and personality variables: HAD, TAS-20, SASB. Intervention: patients with HbA1c
      >70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image
      (SASB: Affinity dimension <284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA.
      AS: 8 group sessions followed by 10 individual sessions. Instructors were a primary care
      physician and a psychotherapist. BBA: 10 group meetings and 5individual sessions with a
      physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.

      Second step will start in 2015: Recruitment of 350 people from primary care with type 2
      diabetes with high A1c and either depression, alexithymia, negative self image or anxiety.
      Randomization procedures and patient characteristics will be assessed in the same way as
      above.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
description: a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
measure: Level of HbA1c
time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
description: Compare the HbA1c level before and after intervention
measure: Alexithymia
time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
description: Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
measure: Anxiety
time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
description: Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
measure: Self-image
time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
description: Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
arm group label: Affect School
arm group type: Active Comparator
description: Psychological group education intervention
arm group label: Body Awareness Therapy
arm group type: Active Comparator
description: Physiotherapeutic psychosomatic intervention
intervention type: Behavioral
intervention name: Affect School
arm group label: Affect School
intervention type: Behavioral
intervention name: Body Awareness Therapy
arm group label: Body Awareness Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Eva O Melin, MD
role: Principal Investigator
affiliation: Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Depression
mesh term: Affective Symptoms