Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Affect school 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
Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method
|
| Active Comparator: Basal body awareness Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings |
Behavioral: Affect School and Basal body awareness
Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method
|
Outcome Measures
Primary Outcome Measures
- Prevalence of depression [3 years]
Evaluate depression score before and after intervention
Secondary Outcome Measures
- Level of A1C [3 years]
Compare the A1C level before and after intervention
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Landstinget Kronoberg | Vaxjo | Kronoberg | Sweden | s-35251 |
Sponsors and Collaborators
- Lund University
- Landstinget Kronoberg, Sweden
Investigators
- Principal Investigator: Eva O Melin, MD, Landstinget Kronoberg, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FoU-Kronoberg Sweden 4522