Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
研究概览
简要总结
The investigators want to try the psycho educational method "The Affect School with Script Analysis and the physiotherapeutic mind-body therapy "Basal Body Awareness Therapy in patients with diabetes, high HbA1c and psychological symptoms, in order to improve psychological health- with the primary outcome reduced depression. Secondary outcomes are improved improved glycemic control and self-image, and reduced alexithymia and anxiety.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Affect School
Psychological group education intervention
干预措施: Affect School (Behavioral)
Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
干预措施: Body Awareness Therapy (Behavioral)
结局指标
主要结局
Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
时间窗: 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
次要结局
- Level of HbA1c(First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline)
- Alexithymia(First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline)
- Anxiety(First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline)
- Self-image(First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline)