Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Depression, Alexithymia, Anxiety

Intervention / Treatment
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* Behavioral: Affect School and Basal body awareness


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affect school<br>Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist | Behavioral: Affect School and Basal body awareness<br>* Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method<br>|
| Active Comparator: Basal body awareness<br>Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings | Behavioral: Affect School and Basal body awareness<br>* Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of depression | Evaluate depression score before and after intervention | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of A1C | Compare the A1C level before and after intervention | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alexithymia, Diabetes mellitus, depression, anxiety, negative self image, metabolic control, diabetes complications