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

NCT03663075 | Completed

• 1 other identifier: U1111-1219-6542
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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)

  Change from baseline to six months after completed intervention

Secondary Outcomes (23)

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

  Change from baseline to six months after completed intervention

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

  Change from baseline to six months after completed intervention

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

  Change from baseline to six months after completed intervention

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

  Change from baseline to six months after completed intervention

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

  Change from baseline to six months after completed intervention

Study Arms (4)

Group 1

EXPERIMENTAL

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

Behavioral: Group information (GI)

Group 2

EXPERIMENTAL

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

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

Group 3

EXPERIMENTAL

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

Behavioral: Structured person-centered support (PCS)

Group 4

NO INTERVENTION

This is a control group.

Interventions

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.

Group 1; Group 2

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.

Group 2; Group 3

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: This study specifically aim to study women in the age 45-60 years attending primary health care for stress related symptoms.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• The woman do not wish to continue participation

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Research and Development Unit

Borås, Västra Götaland County, 503 38, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36964526 RESULT

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Lena Rindner

  Vastra Gotaland region, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study evaluated the effect of groups sessions or individual support. This is not a pill so it is impossible to mask participants.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Two factor design evaluating two separate treatment modalities

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 10, 2018
• Study Start: September 24, 2018
• Primary Completion: February 26, 2020
• Study Completion: November 6, 2020
• Last Updated: June 22, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)