Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)
Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
調査の概要
詳細な説明
Background:
Depression is common in patients with diabetes and is associated with impaired glycemic control and elevated cortisol levels. 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 (BBAT) is a stress-reducing technique and is used in psychiatric care in Scandinavia in order to improve psychiatric health.
Purpose:
The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients at baseline. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with Affect School with Script Analysis and Basal Body Awareness Therapy 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 in two steps. First step started in 2009 and consists of 350 people with diabetes, 90% with type 1 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 HbA1c >70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: Affinity dimension <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: 10 group meetings and 5individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.
Second step will start in 2015: Recruitment of 350 people from primary care with type 2 diabetes with high A1c and either depression, alexithymia, negative self image or anxiety. Randomization procedures and patient characteristics will be assessed in the same way as above.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c >70 mmol/mol, and one of the following: depression, alexithymia, anxiety or a negative self image.
Exclusion Criteria:
•1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure, deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe personality disorder or severe substance abuse), 3) cognitive deficiencies (mental retardation, stroke or dementia); or 5) inadequate Swedish
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Affect School
Psychological group education intervention
|
|
アクティブコンパレータ:Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
時間枠:First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Level of HbA1c
時間枠:First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Compare the HbA1c level before and after intervention
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Alexithymia
時間枠:First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Anxiety
時間枠:First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Self-image
時間枠:First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Eva O Melin, MD、Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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