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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01498614
• Other study ID #: FoU-Kronoberg Sweden 4522
• Status: Terminated
• Phase: N/A
• Start date: March 2009
• Est. completion date: November 28, 2018

Study information

• Verified date: November 2018
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 321
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Symptoms
• Alexithymia
• Anxiety
• Depression
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Sweden	Landstinget Kronoberg	Vaxjo	Kronoberg

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Landstinget Kronoberg, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of depression	Evaluate depression score before and after intervention	3 years
Secondary	Level of A1C	Compare the A1C level before and after intervention	3 years