ALEXIDIAB: Psychological Variables and Hyperglycemia in Diabetes Mellitus

Sponsor

Lund University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01714986

Collaborator

FoU Kronoberg, Landstinget Kronoberg (Other)

Enrollment

Arms

189

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Depression Alexithymia Anxiety	Behavioral: Affect School Behavioral: Body Awareness Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Affect School Psychological group education intervention	Behavioral: Affect School
Active Comparator: Body Awareness Therapy Physiotherapeutic psychosomatic intervention	Behavioral: Body Awareness Therapy

Arm

Intervention/Treatment

Active Comparator: Affect School

Psychological group education intervention

Behavioral: Affect School

Active Comparator: Body Awareness Therapy

Physiotherapeutic psychosomatic intervention

Behavioral: Body Awareness Therapy

Outcome Measures

Primary Outcome Measures

Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c [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

Secondary Outcome Measures

Level of HbA1c [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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