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Completed

NCT Number: NCT03663075

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

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.

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Key information

Conditions

Women's Health Behavior Menopause Mental Health Personal Satisfaction Primary Health Care Psychological Well-Being Quality of Life Sick Leave

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Research and Development Unit

Borås, Västra Götaland County, 503 38, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group information (GI)

Behavioral

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.

Structured person-centered support (PCS)

Behavioral

The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.

Primary outcomes

  1. Short term effect of group education (GI) on change in quality of life

    Time frame: 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)

Secondary outcomes

  1. Short term effect of Structured person-centered support (PCS) on change in days on sick leave

    Time frame: Change from baseline to six months after completed intervention

    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.)

  2. Short term effect of Structured person-centered support (PCS) on change in depressive mood

    Time frame: Change from baseline to six months after completed intervention

    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)

  3. Short term effect of Structured person-centered support (PCS) on change in quality of life

    Time frame: Change from baseline to six months after completed intervention

    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)

  4. Short term effect of Structured person-centered support (PCS) on stress levels

    Time frame: Change from baseline to six months after completed intervention

    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)

  5. Short term effect of group education (GI) on change in days on sick leave

    Time frame: Change from baseline to six months after completed intervention

    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.)

  6. Short term effect of group education (GI) on change in depressive mood

    Time frame: Change from baseline to six months after completed intervention

    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)

  7. Short term effect of group education (GI) on stress levels

    Time frame: Change from baseline to six months after completed intervention

    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).

  8. Long term effect of Structured person-centered support (PCS) on change in days on sick leave

    Time frame: Change from baseline to 12 months after completed intervention

    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.)

  9. Long term effect of Structured person-centered support (PCS) on change in depressive mood

    Time frame: Change from baseline to 12 months after completed intervention

    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)

  10. Long term effect of Structured person-centered support (PCS) on change in quality of life

    Time frame: Change from baseline to 12 months after completed intervention

    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)

  11. Long term effect of Structured person-centered support (PCS) on stress levels

    Time frame: Change from baseline to 12 months after completed intervention

    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)

  12. Long term effect of group education (GI) on change in days on sick leave

    Time frame: Change from baseline to 12 months after completed intervention

    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.)

  13. Long term effect of group education (GI) on change in depressive mood

    Time frame: Change from baseline to 12 months after completed intervention

    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)

  14. Long term effect of group education (GI) on change in quality of life

    Time frame: Change from baseline to 12 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 12 months after completed intervention)

  15. Long term effect of group education (GI) on stress levels

    Time frame: Change from baseline to 12 months after completed intervention

    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).

  16. Short term effect of group education (GI) on levels of anxiety

    Time frame: Change from baseline to 6 months after completed intervention

    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).

  17. Long term effect of group education (GI) on levels of anxiety

    Time frame: Change from baseline to 12 months after completed intervention

    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).

  18. Short term effect of Structured person-centered support (PCS) on levels of anxiety

    Time frame: Change from baseline to 6 months after completed intervention

    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).

  19. Long term effect of Structured person-centered support (PCS) on levels of anxiety

    Time frame: Change from baseline to 12 months after completed intervention

    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).

  20. Short term effect of Structured person-centered support (PCS) on visits to primary health care

    Time frame: Change from baseline to 6 months after completed intervention

    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).

  21. Long term effect of Structured person-centered support (PCS) on visits to primary health care

    Time frame: Change from baseline to 12 months after completed intervention

    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).

  22. Short term effect of group education (GI) on visits to primary health care

    Time frame: Change from baseline to 6 months after completed intervention

    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).

  23. Long term effect of group education (GI) on visits to primary health care

    Time frame: Change from baseline to 12 months after completed intervention

    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).

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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