Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03663075
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2018-08-29
Brief Title:
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 womens 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 GIPCS 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 womens 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
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 andor 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 womens 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 GIPCS 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 womens 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:
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 andor 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 womens 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 GIPCS 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 womens 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
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 andor 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 womens 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 GIPCS 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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None