Clinical trial NCT03663075: Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Quality of Life
Mental Health
Menopause
Primary Health Care
Sick Leave
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2018-09-10
Enrollment: 370
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two factor design evaluating two separate treatment modalities
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short term effect of group education (GI) on change in quality of life
timeFrame: Change from baseline to six months after completed intervention
Secondary outcomes:
measure: Short term effect of Structured person-centered support (PCS) on change in days on sick leave
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of Structured person-centered support (PCS) on change in depressive mood
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of Structured person-centered support (PCS) on change in quality of life
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of Structured person-centered support (PCS) on stress levels
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of group education (GI) on change in days on sick leave
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of group education (GI) on change in depressive mood
timeFrame: Change from baseline to six months after completed intervention
measure: Short term effect of group education (GI) on stress levels
timeFrame: Change from baseline to six months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on change in days on sick leave
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on change in depressive mood
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on change in quality of life
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on stress levels
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of group education (GI) on change in days on sick leave
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of group education (GI) on change in depressive mood
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of group education (GI) on change in quality of life
timeFrame: Change from baseline to 12 months after completed intervention
measure: Long term effect of group education (GI) on stress levels
timeFrame: Change from baseline to 12 months after completed intervention
measure: Short term effect of group education (GI) on levels of anxiety
timeFrame: Change from baseline to 6 months after completed intervention
measure: Long term effect of group education (GI) on levels of anxiety
timeFrame: Change from baseline to 12 months after completed intervention
measure: Short term effect of Structured person-centered support (PCS) on levels of anxiety
timeFrame: Change from baseline to 6 months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on levels of anxiety
timeFrame: Change from baseline to 12 months after completed intervention
measure: Short term effect of Structured person-centered support (PCS) on visits to primary health care
timeFrame: Change from baseline to 6 months after completed intervention
measure: Long term effect of Structured person-centered support (PCS) on visits to primary health care
timeFrame: Change from baseline to 12 months after completed intervention
measure: Short term effect of group education (GI) on visits to primary health care
timeFrame: Change from baseline to 6 months after completed intervention
measure: Long term effect of group education (GI) on visits to primary health care
timeFrame: Change from baseline to 12 months after completed intervention
Other outcomes:
Locations:
city: Boras
country: Sweden
facility: Research and Development Unit
state: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland region, Sweden
name: Lena Rindner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rindner L, Nordeman L, Stromme G, Hange D, Gunnarsson R, Rembeck G. Effect of group education and person-centered support in primary health care on mental health and quality of life in women aged 45-60 years with symptoms commonly associated with stress: a randomized controlled trial. BMC Womens Health. 2023 Mar 24;23(1):128. doi: 10.1186/s12905-023-02221-6.