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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Depression
Alexithymia
Anxiety
Behavioral: Affect School
Behavioral: Body Awareness Therapy
Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Evaluate depression score before and after intervention


Secondary Outcome Measures:
  • Level of A1C [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare the A1C level before and after intervention


Enrollment: 321
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment as usual
No active intervention
Behavioral: Treatment as usual
Active Comparator: Affect School
Psychological group education intervention
Behavioral: Affect School
Active Comparator: Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
Behavioral: Body Awareness Therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714986

Sponsors and Collaborators
Lund University
FoU Kronoberg, Landstinget Kronoberg
Investigators
Principal Investigator: Eva O Melin, MD FoU Kronoberg, Landstinget Kronoberg
  More Information

No publications provided

Responsible Party: Eva Melin, MD, PhD student, Lund University
ClinicalTrials.gov Identifier: NCT01714986     History of Changes
Other Study ID Numbers: FoU-Kronoberg 4522
Study First Received: October 24, 2012
Last Updated: October 25, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Diabetes mellitus
Depression
Anxiety
Alexithymia
Self Image
A1C
Psychoeducation

Additional relevant MeSH terms:
Affective Symptoms
Anxiety Disorders
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mental Disorders
Mood Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014