Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)
|ClinicalTrials.gov Identifier: NCT01714986|
Recruitment Status : Enrolling by invitation
First Posted : October 26, 2012
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Depression Alexithymia Anxiety||Behavioral: Affect School Behavioral: Body Awareness Therapy||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Affect School
Psychological group education intervention
|Behavioral: Affect School|
Active Comparator: Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
|Behavioral: Body Awareness Therapy|
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714986
|Principal Investigator:||Eva O Melin, MD||Fou Kronoberg, Kronoberg County Council, Växjö, Sweden|