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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: June 17, 2014
Last verified: June 2014
  Purpose

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.


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

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:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Kronoberg County Council, Växjö, Sweden
  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: June 17, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Diabetes mellitus
Depression
Anxiety
Alexithymia
Self Image
HbA1c
Psychoeducation

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

ClinicalTrials.gov processed this record on November 23, 2014