Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)
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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 |
- Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]Evaluate depression score before and after intervention
- 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 |
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 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 May 23, 2013