Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
FoU Kronoberg, Landstinget Kronoberg
Information provided by (Responsible Party):
Eva Melin, Lund University
ClinicalTrials.gov Identifier:
NCT01714986
First received: October 24, 2012
Last updated: April 6, 2016
Last verified: April 2016

October 24, 2012
April 6, 2016
March 2009
December 2023   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate depression score before and after intervention
Complete list of historical versions of study NCT01714986 on ClinicalTrials.gov Archive Site
  • Level of HbA1c [ Time Frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline ] [ Designated as safety issue: No ]
    Compare the HbA1c level before and after intervention
  • Alexithymia [ Time Frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline ] [ Designated as safety issue: No ]
    Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
  • Anxiety [ Time Frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline ] [ Designated as safety issue: No ]
    Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
  • Self-image [ Time Frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline ] [ Designated as safety issue: No ]
    Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
Level of A1C [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare the A1C level before and after intervention
Not Provided
Not Provided
 
Psychological Variables and Hyperglycemia in Diabetes Mellitus
Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Depression
  • Alexithymia
  • Anxiety
  • Behavioral: Affect School
  • Behavioral: Body Awareness Therapy
  • Active Comparator: Affect School
    Psychological group education intervention
    Intervention: Behavioral: Affect School
  • Active Comparator: Body Awareness Therapy
    Physiotherapeutic psychosomatic intervention
    Intervention: Behavioral: Body Awareness Therapy
Melin EO, Svensson R, Gustavsson SÅ, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
December 2024
December 2023   (final data collection date for primary outcome measure)

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

Both
18 Years to 59 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01714986
FoU-Kronoberg 4522
No
Not Provided
Not Provided
Eva Melin, Lund University
Lund University
FoU Kronoberg, Landstinget Kronoberg
Principal Investigator: Eva O Melin, MD Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
Lund University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP