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

Vastra Gotaland Region

Status: Completed

Conditions: Women's Health; Menopause; Quality of Life; Sick Leave; Primary Health Care; Mental Health

Treatments: Behavioral: Group information (GI); Behavioral: Structured person-centered support (PCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03663075

U1111-1219-6542

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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370 participants in 4 patient groups

Group 1

Experimental group

Description:

This group will receive the intervention Group information (GI).

Treatment:

Behavioral: Group information (GI)

Group 2

Experimental group

Description:

This group will receive the intervention Group information (GI) followed by Structured person-centered support (PCS)

Treatment:

Behavioral: Structured person-centered support (PCS)

Behavioral: Group information (GI)

Group 3

Experimental group

Description:

This group will receive the intervention Structured person-centered support (PCS)

Treatment:

Behavioral: Structured person-centered support (PCS)

Group 4

No Intervention group

Description:

This is a control group.