Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
This trial is active, not recruiting.
|Conditions||diabetes mellitus, depression, alexithymia, anxiety|
|Treatment||affect school and basal body awareness|
|Collaborator||Landstinget Kronoberg, Sweden|
|Start date||March 2009|
|End date||May 2012|
|Trial size||321 participants|
|Trial identifier||NCT01498614, FoU-Kronoberg Sweden 4522|
Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
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.
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.
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.
|Intervention model||parallel assignment|
Prevalence of depression
time frame: 3 years
Level of A1C
time frame: 3 years
Male or female participants from 18 years up to 59 years old.
Inclusion Criteria: - Type 1 and type 2 diabetes at a specialist outpatient clinic in Vaxjo 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.
|Official title||Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness|
|Principal investigator||Eva O Melin, MD|
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