Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
Condition: Women's Health; Quality of Life; Mental Health; Menopause; Primary Health Care; Sick Leave
Study type: Interventional

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.
    

Intervention name(s): Group information (GI); Structured person-centered support (PCS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Two factor design evaluating two separate treatment modalities
Masking: None (Open Label)
Primary purpose: Treatment