The Effect of Group and Individual Counseling on Mental Health, Quality of Life and Sick Leave in 45-60 Year Old Women With Stress Related Symptoms - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Short term effect of group education (GI) on change in quality of life
研究概览
简要总结
Background:
Stress-related ill health is today the most common cause of long-term sick leave in women in the middle of life and a common cause of visits to primary health care.
Objective:
To implement and investigate the effect of education in group and/or individually held in primary health care clinics embracing aspects of mental health, quality of life, sick leave and the needs women aged 45-60 with stress-related symptoms have.
Method The study is a randomized controlled trial with a two-factor design. The study evaluates both group information (GI) and structured person-centered support (PCS) and possible interaction effects between these two treatment modalities. The group education consists of four information sessions discussing myths around menopause, physiology, local estrogen deficiency symptoms, women's cardiovascular health, stress-related ill health, mental health, relationships, sexuality, lust and possible treatment options. In addition, conversations about insight into obstacles and resources, coping strategies and behavioral changes will be included. The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies. Participants will be block randomized into four groups; GI, PCS, GI+PCS or control.
Expected result Implementation of group and individual support calls is expected to improve health for women seeking primary care care. The results are expected to increase the knowledge of how women's health is affected by short-term care in primary care through reduced sick leave days, reduced care needs, return to work and increased quality of life. The result may improve existing primary care routines for women, and if needed, for a more individualized care contact and support.
详细描述
Background:
Stress-related ill health is today the most common cause of long-term sick leave in women in the middle of life and a common cause of visits to primary health care. Women seem to suffer more than men in the same age group. Few evidence based treatment options exist and none of them has a proven effect on return to work.
Objective:
To implement and investigate the effect of education in group and/or individually held in primary health care clinics embracing aspects of mental health, quality of life, sick leave and the needs women aged 45-60 with stress-related symptoms have.
Method The study is a randomized controlled trial with a two-factor design. The study evaluates both group information (GI) and structured person-centered support (PCS) and possible interaction effects between these two treatment modalities. The group education consists of four information sessions discussing myths around menopause, physiology, local estrogen deficiency symptoms, women's cardiovascular health, stress-related ill health, mental health, relationships, sexuality, lust and possible treatment options. In addition, conversations about insight into obstacles and resources, coping strategies and behavioral changes will be included. The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies. Participants will be block randomized into four groups; GI, PCS, GI+PCS or control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study evaluated the effect of groups sessions or individual support. This is not a pill so it is impossible to mask participants.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The woman has at least one possible stress related problem such as depression, anxiety, gastrointestinal disturbance, unexplained muscular pain or cardiovascular illness such as hypertension or coronary heart disease.
- •The woman have not been on sick leave for more than 30 days during the preceding 60 days.
- •The woman can easily understand and communicate freely in the Swedish language.
- •The woman does not have severe mental illness such as schizophrenia, other psychosis or known neuropsychiatric disorder. The woman is not in terminal palliative care.
- •The woman does not have severe depression (MADRS scores >20 or express suicidal ideation)
排除标准
- •The woman do not wish to continue participation
结局指标
主要结局
Short term effect of group education (GI) on change in quality of life
时间窗: Change from baseline to six months after completed intervention
What is the effect of group education (GI) on quality of life (measured by change in scores in SF36 from baseline to 6 months after completed intervention)
次要结局
- Short term effect of group education (GI) on change in depressive mood(Change from baseline to six months after completed intervention)
- Short term effect of group education (GI) on stress levels(Change from baseline to six months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on stress levels(Change from baseline to 12 months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on change in days on sick leave(Change from baseline to six months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on change in quality of life(Change from baseline to six months after completed intervention)
- Short term effect of group education (GI) on change in days on sick leave(Change from baseline to six months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on stress levels(Change from baseline to six months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on change in depressive mood(Change from baseline to 12 months after completed intervention)
- Long term effect of group education (GI) on change in days on sick leave(Change from baseline to 12 months after completed intervention)
- Long term effect of group education (GI) on change in depressive mood(Change from baseline to 12 months after completed intervention)
- Short term effect of group education (GI) on levels of anxiety(Change from baseline to 6 months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on levels of anxiety(Change from baseline to 6 months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on visits to primary health care(Change from baseline to 6 months after completed intervention)
- Short term effect of Structured person-centered support (PCS) on change in depressive mood(Change from baseline to six months after completed intervention)
- Long term effect of group education (GI) on change in quality of life(Change from baseline to 12 months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on change in days on sick leave(Change from baseline to 12 months after completed intervention)
- Long term effect of group education (GI) on stress levels(Change from baseline to 12 months after completed intervention)
- Long term effect of group education (GI) on levels of anxiety(Change from baseline to 12 months after completed intervention)
- Long term effect of group education (GI) on visits to primary health care(Change from baseline to 12 months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on change in quality of life(Change from baseline to 12 months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on levels of anxiety(Change from baseline to 12 months after completed intervention)
- Long term effect of Structured person-centered support (PCS) on visits to primary health care(Change from baseline to 12 months after completed intervention)
- Short term effect of group education (GI) on visits to primary health care(Change from baseline to 6 months after completed intervention)