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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01498614
Other study ID # FoU-Kronoberg Sweden 4522
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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