Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
Primary Purpose
Diabetes Mellitus, Depression, Alexithymia
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Affect School and Basal body awareness
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, depression, anxiety, negative self image, alexithymia, metabolic control, diabetes complications
Eligibility 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.
Sites / Locations
- Landstinget Kronoberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Affect school
Basal body awareness
Arm Description
Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist
Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings
Outcomes
Primary Outcome Measures
Prevalence of depression
Evaluate depression score before and after intervention
Secondary Outcome Measures
Level of A1C
Compare the A1C level before and after intervention
Full Information
NCT ID
NCT01498614
First Posted
December 21, 2011
Last Updated
November 28, 2018
Sponsor
Lund University
Collaborators
Landstinget Kronoberg, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01498614
Brief Title
Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
Official Title
Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator no longer at LU.
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Landstinget Kronoberg, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Depression, Alexithymia, Anxiety
Keywords
Diabetes mellitus, depression, anxiety, negative self image, alexithymia, metabolic control, diabetes complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Affect school
Arm Type
Experimental
Arm Description
Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist
Arm Title
Basal body awareness
Arm Type
Active Comparator
Arm Description
Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings
Intervention Type
Behavioral
Intervention Name(s)
Affect School and Basal body awareness
Intervention Description
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 Measure Information:
Title
Prevalence of depression
Description
Evaluate depression score before and after intervention
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Level of A1C
Description
Compare the A1C level before and after intervention
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva O Melin, MD
Organizational Affiliation
Landstinget Kronoberg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landstinget Kronoberg
City
Vaxjo
State/Province
Kronoberg
ZIP/Postal Code
s-35251
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
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