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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03663075
Study type Interventional
Source Vastra Gotaland Region
Contact
Status Completed
Phase N/A
Start date September 24, 2018
Completion date November 6, 2020

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