Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)
| Tracking Information | |||||
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| First Received Date ICMJE | October 24, 2012 | ||||
| Last Updated Date | October 25, 2012 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of depression [ Time Frame: 3 years ] [ Designated as safety issue: No ] Evaluate depression score before and after intervention |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01714986 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Level of A1C [ Time Frame: 3 years ] [ Designated as safety issue: No ] Compare the A1C level before and after intervention |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Psychological Variables and Hyperglycemia in Diabetes Mellitus | ||||
| Official Title ICMJE | Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness | ||||
| Brief Summary | We want to investigate if a specific group educational method - The Affect School - can improve the blood sugar levels of patients with diabetes who have difficulties managing their disease and at the same time show signs of psychological and emotional problems such as depression and alexithymia (difficulties identifying and describing feelings) Our primary hypothesis is that more patients with diabetes have emotional problems such as alexithymia than the general population and that this impairs their abilities to manage their diabetes disease. Our secondary hypothesis is that a group intervention directed at recognizing feelings and discerning them from body signals caused by the diabetes disease would improve the patients' abilities to manage their diabetes disease. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 321 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 59 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01714986 | ||||
| Other Study ID Numbers ICMJE | FoU-Kronoberg 4522 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eva Melin, Lund University | ||||
| Study Sponsor ICMJE | Lund University | ||||
| Collaborators ICMJE | FoU Kronoberg, Landstinget Kronoberg | ||||
| Investigators ICMJE |
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| Information Provided By | Lund University | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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