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Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)

Primary Purpose

Diabetes Mellitus, Depression, Alexithymia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Affect School
Body Awareness Therapy
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Depression, Anxiety, Alexithymia, Self Image, HbA1c, Psychoeducation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c >70 mmol/mol, and one of the following: depression, alexithymia, anxiety or a negative self image.

Exclusion Criteria:

•1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure, deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe personality disorder or severe substance abuse), 3) cognitive deficiencies (mental retardation, stroke or dementia); or 5) inadequate Swedish

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Affect School

    Body Awareness Therapy

    Arm Description

    Psychological group education intervention

    Physiotherapeutic psychosomatic intervention

    Outcomes

    Primary Outcome Measures

    Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
    a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy

    Secondary Outcome Measures

    Level of HbA1c
    Compare the HbA1c level before and after intervention
    Alexithymia
    Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
    Anxiety
    Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
    Self-image
    Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)

    Full Information

    First Posted
    October 24, 2012
    Last Updated
    December 19, 2018
    Sponsor
    Lund University
    Collaborators
    FoU Kronoberg, Landstinget Kronoberg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01714986
    Brief Title
    Psychological Variables and Hyperglycemia in Diabetes Mellitus
    Acronym
    ALEXIDIAB
    Official Title
    Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not active
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lund University
    Collaborators
    FoU Kronoberg, Landstinget Kronoberg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Depression, Alexithymia, Anxiety
    Keywords
    Diabetes mellitus, Depression, Anxiety, Alexithymia, Self Image, HbA1c, Psychoeducation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Affect School
    Arm Type
    Active Comparator
    Arm Description
    Psychological group education intervention
    Arm Title
    Body Awareness Therapy
    Arm Type
    Active Comparator
    Arm Description
    Physiotherapeutic psychosomatic intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Affect School
    Intervention Type
    Behavioral
    Intervention Name(s)
    Body Awareness Therapy
    Primary Outcome Measure Information:
    Title
    Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
    Description
    a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
    Time Frame
    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
    Secondary Outcome Measure Information:
    Title
    Level of HbA1c
    Description
    Compare the HbA1c level before and after intervention
    Time Frame
    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
    Title
    Alexithymia
    Description
    Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
    Time Frame
    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
    Title
    Anxiety
    Description
    Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
    Time Frame
    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
    Title
    Self-image
    Description
    Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
    Time Frame
    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c >70 mmol/mol, and one of the following: depression, alexithymia, anxiety or a negative self image. Exclusion Criteria: •1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure, deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe personality disorder or severe substance abuse), 3) cognitive deficiencies (mental retardation, stroke or dementia); or 5) inadequate Swedish
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva O Melin, MD
    Organizational Affiliation
    Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27121185
    Citation
    Melin EO, Svensson R, Gustavsson SA, Winberg A, Denward-Olah E, Landin-Olsson M, Thulesius HO. Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials. Trials. 2016 Apr 27;17(1):221. doi: 10.1186/s13063-016-1347-8.
    Results Reference
    derived

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    Psychological Variables and Hyperglycemia in Diabetes Mellitus

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