Clinical Trial: Psychological Variables and Hyperglycemia in Diabetes Mellitus

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness

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 Summary:

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 ≥
Sponsor: Lund University

Current Primary Outcome: 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 ]

a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy


Original Primary Outcome: Prevalence of depression [ Time Frame: 3 years ]

Evaluate depression score before and after intervention


Current Secondary Outcome:

  • Level of HbA1c [ Time Frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline ]
    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 ]
    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 ]
    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 ]
    Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)


Original Secondary Outcome: Level of A1C [ Time Frame: 3 years ]

Compare the A1C level before and after intervention


Information By: Lund University

Dates:
Date Received: October 24, 2012
Date Started: March 2009
Date Completion: December 2024
Last Updated: April 6, 2016
Last Verified: April 2016