Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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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

Conditions
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Women's Health, Quality of Life, Mental Health, Menopause, Primary Health Care, Sick Leave

Intervention / Treatment
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* Behavioral: Group information (GI)
* Behavioral: Structured person-centered support (PCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: The woman do not wish to continue participation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Two factor design evaluating two separate treatment modalities
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>This group will receive the intervention Group information (GI). | Behavioral: Group information (GI)<br>* The group education consists of four information sessions discussing myths and 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.<br>|
| Experimental: Group 2<br>This group will receive the intervention Group information (GI) followed by Structured person-centered support (PCS) | Behavioral: Group information (GI)<br>* The group education consists of four information sessions discussing myths and 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.<br>Behavioral: Structured person-centered support (PCS)<br>* The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.<br>|
| Experimental: Group 3<br>This group will receive the intervention Structured person-centered support (PCS) | Behavioral: Structured person-centered support (PCS)<br>* The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.<br>|
| No Intervention: Group 4<br>This is a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term effect of group education (GI) on change in quality of life | 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) | Change from baseline to six months after completed intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term effect of Structured person-centered support (PCS) on change in days on sick leave | What is the effect of Structured person-centered support (PCS) on change in number of days on sick leave. (At baseline the number of days on sick leave up until present time is stated by women currently being on sick leave. At the 6 month follow the same information is retrieved is retrieved. The change is the difference between these measurements.) | Change from baseline to six months after completed intervention | 
| Short term effect of Structured person-centered support (PCS) on change in depressive mood | What is the effect of Structured person-centered support (PCS) on depressive mood (measured by change in scores in MADRS from baseline to 6 months after completed intervention) | Change from baseline to six months after completed intervention | 
| Short term effect of Structured person-centered support (PCS) on change in quality of life | What is the effect of Structured person-centered support (PCS) on quality of life (measured by change in scores in SF36 from baseline to 6 months after completed intervention) | Change from baseline to six months after completed intervention | 
| Short term effect of Structured person-centered support (PCS) on stress levels | What is the effect of Structured person-centered support (PCS) on stress levels (measured by change in scores in PSS-14 from baseline to 6 months after completed intervention) | Change from baseline to six months after completed intervention | 
| Short term effect of group education (GI) on change in days on sick leave | What is the effect of group education (GI) on change in number of days on sick leave. (At baseline the number of days on sick leave up until present time is stated by women currently being on sick leave. At the 6 month follow the same information is retrieved is retrieved. The change is the difference between these measurements.) | Change from baseline to six months after completed intervention | 
| Short term effect of group education (GI) on change in depressive mood | What is the effect of group education (GI) on depressive mood (measured by change in scores in MADRS from baseline to 6 months after completed intervention) | Change from baseline to six months after completed intervention | 
| Short term effect of group education (GI) on stress levels | What is the effect of group education (GI) on stress levels (measured by change in scores in PSS-14 from baseline to 6 months after completed intervention). | Change from baseline to six months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on change in days on sick leave | What is the effect of Structured person-centered support (PCS) on change in number of days on sick leave. (At baseline the number of days on sick leave up until present time is stated by women currently being on sick leave. At the 12 month follow the same information is retrieved is retrieved. The change is the difference between these measurements.) | Change from baseline to 12 months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on change in depressive mood | What is the effect of Structured person-centered support (PCS) on depressive mood (measured by change in scores in MADRS from baseline to 12 months after completed intervention) | Change from baseline to 12 months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on change in quality of life | What is the effect of Structured person-centered support (PCS) on quality of life (measured by change in scores in SF36 from baseline to 12 months after completed intervention) | Change from baseline to 12 months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on stress levels | What is the effect of Structured person-centered support (PCS) on stress levels (measured by change in scores in PSS-14 from baseline to 12 months after completed intervention) | Change from baseline to 12 months after completed intervention | 
| Long term effect of group education (GI) on change in days on sick leave | What is the effect of group education (GI) on change in number of days on sick leave. (At baseline the number of days on sick leave up until present time is stated by women currently being on sick leave. At the 12 month follow the same information is retrieved is retrieved. The change is the difference between these measurements.) | Change from baseline to 12 months after completed intervention | 
| Long term effect of group education (GI) on change in depressive mood | What is the effect of group education (GI) on depressive mood (measured by change in scores in MADRS from baseline to 12 months after completed intervention) | Change from baseline to 12 months after completed intervention | 
| Long term effect of group education (GI) on change in quality of life | What is the effect of group education (GI) on quality of life (measured by change in scores in SF36 from baseline to 12 months after completed intervention) | Change from baseline to 12 months after completed intervention | 
| Long term effect of group education (GI) on stress levels | What is the effect of group education (GI) on stress levels (measured by change in scores in PSS-14 from baseline to 12 months after completed intervention). | Change from baseline to 12 months after completed intervention | 
| Short term effect of group education (GI) on levels of anxiety | What is the effect of group education (GI) on stress levels (measured by change in scores in HAD from baseline to 6 months after completed intervention). | Change from baseline to 6 months after completed intervention | 
| Long term effect of group education (GI) on levels of anxiety | What is the effect of group education (GI) on stress levels (measured by change in scores in HAD from baseline to 12 months after completed intervention). | Change from baseline to 12 months after completed intervention | 
| Short term effect of Structured person-centered support (PCS) on levels of anxiety | What is the effect of Structured person-centered support (PCS) on stress levels (measured by change in scores in HAD from baseline to 6 months after completed intervention). | Change from baseline to 6 months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on levels of anxiety | What is the effect of Structured person-centered support (PCS) on stress levels (measured by change in scores in HAD from baseline to 12 months after completed intervention). | Change from baseline to 12 months after completed intervention | 
| Short term effect of Structured person-centered support (PCS) on visits to primary health care | What is the effect of Structured person-centered support (PCS) on visits to primary health care (women are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 6 months. The measurement is the change in proportion of women who visited the primary health care center). | Change from baseline to 6 months after completed intervention | 
| Long term effect of Structured person-centered support (PCS) on visits to primary health care | What is the effect of Structured person-centered support (PCS) on visits to primary health care (women are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 12 months. The measurement is the change in proportion of women who visited the primary health care center). | Change from baseline to 12 months after completed intervention | 
| Short term effect of group education (GI) on visits to primary health care | What is the effect of group education (GI) on visits to primary health care (women are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 6 months. The measurement is the change in proportion of women who visited the primary health care center). | Change from baseline to 6 months after completed intervention | 
| Long term effect of group education (GI) on visits to primary health care | What is the effect of group education (GI) on visits to primary health care (women are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 12 months. The measurement is the change in proportion of women who visited the primary health care center). | Change from baseline to 12 months after completed intervention |