Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)

This study has been completed.
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: October 25, 2012
Last verified: October 2012

October 24, 2012
October 25, 2012
March 2009
November 2011   (final data collection date for primary outcome measure)
Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evaluate depression score before and after intervention
Same as current
Complete list of historical versions of study NCT01714986 on ClinicalTrials.gov Archive Site
Level of A1C [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare the A1C level before and after intervention
Same as current
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

We want to investigate if a specific group educational method - The Affect School - can improve the blood sugar levels of patients with diabetes who have difficulties managing their disease and at the same time show signs of psychological and emotional problems such as depression and alexithymia (difficulties identifying and describing feelings)

Our primary hypothesis is that more patients with diabetes have emotional problems such as alexithymia than the general population and that this impairs their abilities to manage their diabetes disease.

Our secondary hypothesis is that a group intervention directed at recognizing feelings and discerning them from body signals caused by the diabetes disease would improve the patients' abilities to manage their diabetes disease.

Background:

Depression is common in patients with diabetes and is associated with impaired metabolic control. 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 (BBA) is a stress-reducing technique.

Purpose:

Our aim is to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with AS and BBA 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 of 350 people with 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 A1c ≥ 8 and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: AFF <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: 9 group meetings and 6 individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cytokines, hormones, cortisol.

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
  • Behavioral: Treatment as usual
  • Active Comparator: Treatment as usual
    No active intervention
    Intervention: Behavioral: Treatment as usual
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
April 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 and type 2 diabetes at a specialist outpatient clinic in Vaxjo, Sweden

Exclusion Criteria:

  • Other severe somatic disorder, including being deaf or blind.
  • Severe psychiatric disorder requiring psychiatric specialist care;
  • psychotic disorder,
  • bipolar disorder,
  • severe drug abuse.
  • Inadequate knowledge of Swedish.
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01714986
FoU-Kronoberg 4522
No
Eva Melin, Lund University
Lund University
FoU Kronoberg, Landstinget Kronoberg
Principal Investigator: Eva O Melin, MD FoU Kronoberg, Landstinget Kronoberg
Lund University
October 2012

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