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

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ClinicalTrials.gov Identifier: NCT01498614
Recruitment Status : Unknown
Verified December 2011 by Eva Melin, Lund University.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
Sponsor:
Collaborator:
Landstinget Kronoberg, Sweden
Information provided by (Responsible Party):
Eva Melin, Lund University

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
Diabetes Mellitus Depression Alexithymia Anxiety Behavioral: Affect School and Basal body awareness Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2009
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Prevalence of depression [ Time Frame: 3 years ]
    Evaluate depression score before and after intervention


Secondary Outcome Measures :
  1. Level of A1C [ Time Frame: 3 years ]
    Compare the A1C level before and after intervention



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eva Melin, MD, PhD student, Lund University
ClinicalTrials.gov Identifier: NCT01498614     History of Changes
Other Study ID Numbers: FoU-Kronoberg Sweden 4522
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Affective Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms