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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Landstinget Kronoberg, Sweden
Information provided by (Responsible Party):
Eva Melin, Lund University
ClinicalTrials.gov Identifier:
NCT01498614
First received: December 21, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus
Depression
Alexithymia
Anxiety
 Behavioral: Affect School and Basal body awareness

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Evaluate depression score before and after intervention


Secondary Outcome Measures:
  • Level of A1C [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare the A1C level before and after intervention


Enrollment: 321
Study Start Date: March 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498614

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Eva Melin, MD, PhD student, Lund University
ClinicalTrials.gov Identifier: NCT01498614     History of Changes
Other Study ID Numbers: FoU-Kronoberg Sweden 4522
Study First Received: December 21, 2011
Last Updated: December 22, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Diabetes mellitus
depression
anxiety
negative self image
 alexithymia
metabolic control
diabetes complications

Additional relevant MeSH terms:
Affective Symptoms
Anxiety Disorders
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
 Mental Disorders
Mood Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013