Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, depression, alexithymia, anxiety
Treatment affect school and basal body awareness
Sponsor Lund University
Collaborator Landstinget Kronoberg, Sweden
Start date March 2009
End date May 2012
Trial size 321 participants
Trial identifier NCT01498614, FoU-Kronoberg Sweden 4522

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist
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 is an educational method with 9 group sessions followed by 6 individual meetings
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

Primary Outcomes

Measure
Prevalence of depression
time frame: 3 years

Secondary Outcomes

Measure
Level of A1C
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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.

Additional Information

Official title Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Principal investigator Eva O Melin, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Lund University.