Moving on! Can a Tailored Treatment in a Primary Care Setting Reduce Symptoms, Healthcare Consumption, Sick Leave and Prevent Pain and Hypertension in Individuals With Anxiety Disorders?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Symptoms of anxiety - BAI
研究概览
简要总结
The goal of this clinical study is to investigate the effects of two different interventions in patients with anxiety disorder and who seeks help at primary care centers. The participants will choose between two interventions:
- A 12-week physical exercise program with three training sessions per week, or
- A modified version of eHealth Lift, a digital development of the Health Lift, an evidence based lifestyle-intervention for health promotion and prevention in primary health care.
The participant will fill in self-assessment scales and questionnaires and also have BMI and blood pressure measured at the start of the study, at 12-weeks after the study start and after 1 year.
The main question the investigators aim to answer is if the interventions are better than treatment as usual for this group of patients regarding:
- symptoms of anxiety and depression
- pain
- sleep
- alcohol habits
- fatigue
- general health
- work ability/sick leave
- physical activity
- perceived quality of life
- BMI and blood pressure
- number of health care contacts
- psychopharmaceuticals and analgesics prescribed
- health literacy
详细描述
Every third patient in the waiting room at a Swedish primary healthcare center is seeking help for common mental disorders including anxiety (1). Anxiety disorders substantially reduce quality of life and daily functioning and are, among mental disorders, the second leading cause of years lived with disability and the sixth-leading cause of disability globally. Anxiety disorders are also associated with elevated risks of pain, cardiovascular disease (CVD) and premature mortality (2), emphasizing the importance of finding effective treatment strategies that can be addressed in primary care.
Specific research questions:
- Can a tailored treatment and secondary prevention in a primary care setting reduce symptoms of anxiety, healthcare consumption, sick leave, pain and prevent hypertension in individuals with anxiety disorders?
- Are there long-term effects at 1 year of follow-up regarding the outcome measures?
- Is the treatment/secondary preventive strategy associated with health economic benefits?
Significance and scientific novelty: Despite the high burden of anxiety, there are major knowledge gaps when it comes to secondary preventive measures. This intervention aims to reduce anxiety, improve the quality of life, work ability and health in primary health care patients with anxiety disorders. Little research has focused on lifestyle improvements or exercise specifically in the treatment of anxiety. In Sweden there are guidelines from The National Board of Health and welfare for treatment of depression with exercise, but guidelines for treatment of anxiety disorders are currently lacking. Also results from this study may extend the current understanding and practice in the field of treatment and secondary prevention of anxiety disorders within primary care.
This project aims to combine evidence-based interventions to tailor a lifestyle intervention with different steps focusing on patient control and participation since the individual chooses the intervention arm. Two evidence-based lifestyle interventions will combined and evaluated: the modified eHealth Lift/Care manager according to regional clinical guidelines and PHYSBI, a promising new strategy with an intensive training program, a new approach for treating anxiety disorders. If a simple intervention program in primary care can alleviate anxiety, improve quality of life, cognitive performance, and work ability, prevent pain and hypertension, this may have a great positive impact both at the individual level and from a societal perspective. The investigators hope to increase the availability of person-centered, evidence-based and cost-effective measures to promote both physical and mental health in patients with anxiety disorders. Moreover, the interventions are designed to easily be implemented in regular primary care activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of anxiety disorder (panic syndrome, 41.0; generalized anxiety, F41.1; mixed anxiety- and depression, F41.2 and F41.3; anxiety not otherwise specified, F41.9).
- •Seeking care at primary care centers within the Region Västra Götaland.
- •With or without ongoing treatment with psychoactive medication (antidepressants or anxiolytics).
排除标准
- •Pregnancy
- •Physical difficulties in performing a physical exercise program
- •Pathological electrocardiogram
- •Low BMI (under 17.5)
- •Ongoing alcohol/substance abuse
- •Ongoing exhaustion disorder or psychotic disorder
- •Newly discovered (within 6 months) atrial fibrillation
- •High suicide risk as assessed by the general practitioner
- •Limited knowledge in the Swedish language.
结局指标
主要结局
Symptoms of anxiety - BAI
时间窗: After one year follow-up
Established psychiatric self-assessment scale Beck Anxiety Inventory (BAI). BAI is organized in 21 items, with scoring from nothing (0 p), slightly (1 p), moderately (2p) and severely (3p) and total ratings range from nothing, minimal/mild (score 0-15), moderately (score 16-25) and severely (score 26-63).
Symptoms of Generalized Anxiety Disorder - GAD-7
时间窗: After one year follow-up
An established psychiatric self-assessment scale GAD-7 (Symptoms of Generalized Anxiety Disorder). A 7-item scale where anxiety severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety
Symptoms of anxiety - HAD
时间窗: After one year follow-up
The established psychiatric self-assessment scale HAD (Hospital Anxiety and Depression Scale Symptoms of anxiety) is a scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Score 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal (case).
Symptoms of inner tension - MADRS-S; question 2
时间窗: After one year follow-up
The established psychiatric self-assessment scale MADRS-S (Montgomery-Åsberg Depression Rating Scale); question 2, which asks about inner tension (a proxy for anxiety). The question is scaled from 0 to 6, with higher scores reflecting more severe symptoms.
次要结局
- Symptoms of depression - MADRS-S(After one year follow-up)
- Symptoms of pain - PSQ(After one year follow-up)
- Sleep quality - ISI(After one year follow-up)
- Alcohol habits - AUDIT(After one year follow-up)
- Fatigue - MFS(After one year follow-up)
- Health-related quality of life - EQ-5D(After one year follow-up)
- Work ability - C2WI(After one year follow-up)
- Physical activity - IPAQ(After one year follow-up)
- Body mass index - BMI(After one year follow-up)
- Blood pressure - mmHg(After one year follow-up)
- Health care contacts - registry data(After one year follow-up)
- Prescribed medication - registry data(After one year follow-up)
- Sick leave - registry data(After one year follow-up)
- Mental and Physical health - registry data(After one year follow-up)
- Sick leave and work ability - questionnaire(After one year follow-up)
- Used psychopharmaceuticals - questionnaire(After one year follow-up)
- Physical activity - questionnaire(After one year follow-up)
- Pain - questionnaire(After one year follow-up)
- Health care consumption - questionnaire(After one year follow-up)