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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663075
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Women's Health Quality of Life Mental Health Menopause Primary Health Care Sick Leave Behavioral: Group information (GI) Behavioral: Structured person-centered support (PCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Two factor design evaluating two separate treatment modalities
Masking: None (Open Label)
Masking Description: This study evaluated the effect of groups sessions or individual support. This is not a pill so it is impossible to mask participants.
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Group 1
This group will receive the intervention Group information (GI).
Behavioral: Group information (GI)
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.

Experimental: Group 2
This group will receive the intervention Group information (GI) followed by Structured person-centered support (PCS)
Behavioral: Group information (GI)
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.

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

Experimental: Group 3
This group will receive the intervention Structured person-centered support (PCS)
Behavioral: Structured person-centered support (PCS)
The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.

No Intervention: Group 4
This is a control group.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study specifically aim to study women in the age 45-60 years attending primary health care for stress related symptoms.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663075


Locations
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Sweden
Research and Development Unit
Boras, Vastra Gotaland, Sweden, 503 38
Sponsors and Collaborators
Vastra Gotaland Region
Göteborg University
Investigators
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Principal Investigator: Lena Rindner Vastra Gotaland region, Sweden
  Study Documents (Full-Text)

Documents provided by Vastra Gotaland Region:
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03663075    
Other Study ID Numbers: U1111-1219-6542
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The descriptive data provided will be summary data for each group. The investigators will not show data from single participants.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No