Depression Clinical Trial
Official title:
Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes:
Intervention Study With Affect School and Basal Body Awareness
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.
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