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
Phase: NA
Conditions: Women's Health, Quality of Life, Mental Health, Menopause, Primary Health Care, Sick Leave
Sponsor: Vastra Gotaland Region

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
Effect of primary care education on mental health, quality of life, need for 
sick leave and health care consumption in women 45-60 years with stress-
related symptoms. A randomized controlled trial. 
 
Principal investigator 
Lena Rindner, RN, ADB, PhMag, PhD Student 
Närhälsan, Health Care, Borås, The Research and Development Center Södra Älvsborg, 
Närhälsan, Research and Development, Primary Health Care Region Västra Götaland, 
Department of Public Health and Community Medicine/Primary Health Care, Institute of 
Medicine, the Sahlgrenska Academy, University of Gothenburg, Sweden 
e-mail: lena.rindner@vgregion.se  
Co-investigators 
Lena Nordeman, RPT, PhD 
Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, 
Primary Health Care Region, Västra Götaland, Sweden  
University of Gothenburg, Sahlgrenska Academy, Institute of Neuroscience and Physiology 
Department of Health and Rehabilitation, Unit of Physiotherapy, Sweden. 
e-mail: lena.nordeman@vgregion.se  
Dominique Hange, MD, PhD, Docent, Associate Professor 
Närhälsan, Svenljunga Health Care Center, Department of Public Health and Community 
Medicine/Primary Health Care, Institute of Medicine, the Sahlgrenska Academy, University 
of Gothenburg, Sweden 
e-post: dominique.hange@vgregion.se 
 
Ronny Gunnarsson, MD, PhD, Adjunct Professor  
Research and Development Center Södra Älvsborg, Närhälsan, Research and Development 
Department of Public Health and Community Medicine/Primary Health Care, Institute of 
Medicine, the Sahlgrenska Academy, University of Gothenburg, Sweden 
e-mail: ronny.gunnarsson@infovoice.se 
Gun Rembeck, RN, RM, PhD 
Närhälsan, Research and Development, Primary Health Care Region Västra Götaland,  
The Research and Development Center Södra Älvsborg, Borås, Närhälsan Borås Young 
Persons Clinic, Sweden  
e-mail: gun.rembeck@vgregion.se  

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
Åsa Premberg, RN, RM, RhD 
Research and Development Primary Health Care,R&D Centre Gothenburg and Södra 
Bohuslän. 
e-mail: asa.premberg@vgregion.se 
Irene Svenningsson, RN, AND, PhD 
Research and Development Primary Health Care, R,D & E Centre Fyrbodal, Sweden 
e-mail: irene.sveningsson@vgregion.se 
Gunilla Strömme, RN, RM, B Sc 
Närhälsan Mark Antenatal Clinic, Sweden 
e-mail: gunilla.stromme@vgregion.se 
Arne Rindner, MD 
Södra Älvsborgs Hospital, Borås, Sweden 
e-mail: arne.rindner@vgregion.se 
Håkan Wallgren 
Frölunda sjukhus, Västra Frölunda, Sweden 
e-mail: hakwa61@gmail.com  

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
 
 
Summary 
Background 
Stress related ill health is today a common cause for long term sick leave among women in 
their midst of life as well as being a common cause for visits to the primary health care. 
Aim 
To investigate the effect on mental health, quality of life and sick leave of education provided 
within the primary health care given in group or individually for women aged 45-60 years 
with stress related symptoms. 
Methods 
This is a randomised controlled clinical trial using a two factor design. 
Education is given as four sessions exploring menopause, physiology, oestrogen deficiency, 
cardiovascular health, consequences of stress, mental health, relationships, sexuality and lust 
as well as potential actions to improve the situation. In addition, the group sessions will touch 
base on topics like obstacles and resources, coping strategies, and behavioural changes. 
The individual education will be person-centred and given as five sessions focusing on stress 
related symptoms, ill health, physiology and coping strategies. 
Expected result 
If any of these two interventions turns out to be successful it may provide low cost 
intervention options for a common problem often seen in primary health care. 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
Introduction 
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 primary care visits (1). It is clear that women suffer 
from long-term sickness and ill health to a greater degree than men (2). Women's physical and 
mental health in Sweden shows a marked decrease in the ages of 45-60 years (3). During this 
life phase, called menopause, the woman undergoes a hormonal transformation (3). Stress-
related symptoms appear after a long time with high stress load without sufficient recovery 
(4). There are currently few studies with high evidence-based treatment on stress-related 
symptoms (5). Busch et al show in an evaluation that 70% of people who have undergone 
rehabilitation overall are satisfied with the treatment. The treatment, on the other hand, has 
not led to increased return to work (6). 
Research shows that women often lack information about physical and mental and urogenital 
changes under the "middle of life" / menopause (7). 
Group education is a method and participation in group education can be a good way for 
women to get information and exchange experiences (8). 
Earlier studies evaluating patient education in hypertonia and diabetes show significant 
improvement (9.10). Talking can raise awareness about choices and consequences, create 
insight into behaviours and provide insight into the overall life situation to find the core of ill 
health (11). Arving et al shows that health-related quality of life increased faster in patients 
receiving support calls than those who received normal treatment (12). 
There is a lack of primary care studies that evaluate the effect of education in group and / or 
individually for women 45-60 years with stress-related symptoms. 
The wast number of middle aged women with ill health and subsequent high risk for disease 
risk and increasing number of long-term sick leave shows that it is important to study 
women's health in this age group. 
Aim 
To study the effect of education in a group or individually delivered in primary health care on 
mental health, quality of life and sick leave in women aged 45-60 with stress-related 
symptoms. 
Research questions 
A. Is there any effect of group information (GI) on quality of life, mental health, sick leave or 
visits to a primary health care centre compared to a control group? 
1. 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) – 
Primary research question (other questions are secondary). 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
2. 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)  
3. 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.)  
4. 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.)  
5. 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)  
6. 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)  
7. 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. 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).  
9. 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).  
10. 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).  
11. 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). 
12. 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). 
B. Is there any effect of structured person-centered support (PCS) on quality of life, mental 
health, sick leave or visits to a primary health care centre compared to a control group? 
13. 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)? 
14. 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)? 
15. 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 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
until present time is stated by women currently being on sick leave. At the 6 
months follow the same information is retrieved is retrieved. The change is the 
difference between these measurements.) 
16. 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 
months follow the same information is retrieved is retrieved. The change is the 
difference between these measurements.)  
17. 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)? 
18. 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)? 
19. 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)? 
20. 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)? 
21. 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)? 
22. 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)? 
23. 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)? 
24. 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)? 
Methods 
Selection of patients, inclusion criteria and logistics 
Women, 45-60 years old, reached through advertisements in newspapers and on a website, are 
offered to participate in the study. Application for participation in the study is made 
electronically via Fou Primary Care Södra Älvsborg website or by telephone to research 
nurse. Inclusion criteria: 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
a. The woman has some mental and / or physical health problems such as 
depression, anxiety, gastrointestinal symptoms, muscular symptoms and / or 
cardiovascular symptoms. 
b. The woman has been on sick leave for a maximum of 30 days in the last two 
months. 
c. The woman has no major language difficulties that prevent understanding and 
speaking Swedish language as well as filling in forms. 
d. Woman lacks serious illness such as psychosis, severe depression or dementia 
e. The woman is not treated in palliative care 
f. The woman has no ongoing drug or alcohol abuse. 
Research nurse contacts the woman via telephone and provides further information about the 
study where the opportunity is given to ask questions. If the woman meets all inclusion 
criteria and choose to accept the study, electronically self-administered questionnaires about 
self-assessed health and health-related quality of life will be sent to all participants, as well as 
a written informed consent that is signed. Self-administered questionnaires and consent kits 
are filled in via link on R & D Primary Care Södra Älvsborg's website. 
The research nurse is responsible for administration of questionnaires and arranging physical 
check-up. 
Group allocation 
Research randomizer is used to generate a random series based on block-randomization in 
blocks of four. The random series is transferred to closed sealed opaque envelopes, each 
containing group assignment. The manufacture of these closed envelopes is done by a person 
who is not involved in the study. 
Randomization occurs after the woman answered all questionnaires at baseline. Then the 
research nurse opens the next sealed numbered envelope and the patch inside describes what 
group the woman is allocated to: 
• Group 1: group information (GI) 
• Group 2: group information (GI) + person-centred support (PCS) 
• Group 3: person-centred support (PCS) 
• Group 4: no GI or PCS (control group) 
Intervention 
Group information (GI). 
Midwives and district nurses participate as group leaders. Each group training includes 12 
women and comprises four one-and-a-half hours of information with topics related to physical 
and mental changes in the body as well as conversations aimed to make behaviour, 
consequences of behaviour and choices in life conscious. 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
The first group event contains education with the definition and myths of "middle of life" / 
menopause, physiology, menstrual cycle, hormonal conversion, local oestrogen deficiency 
symptoms, osteoporosis and information on treatment options and self-care advice. 
The second group event contains teaching and information on cardiovascular health, its risk 
and health factors, physiology, mental health, relationships, sexuality and lust as well as 
information on treatment options and self-care advice. 
The third group event contains insights into stress-related ill health, physiology, social 
relationships in family and work, sexuality and lust, insight into obstacles and resources, 
coping strategies and behavioural changes to promote health. 
The fourth group event contains insights on relationships, sexuality and lust as well as a 
summary of "How do we want to live to feel good?" Insight into obstacles and resources, 
coping strategies and behavioural changes to promote health. 
Structured person-centred support (PCS): 
Individually structured person-centred education is carried out by a district nurse or midwife. 
It includes five sessions. The conversation contains dialogue on symptoms of stress-related ill 
health, what is happening in the body (physiology), relationships, coping strategies, 
requirements, guilt, exercise and diet. Women randomized to receive both group education 
and individual education will receive group education first. 
Control 
The research nurse informs women in all groups that they can contact the primary health care 
centre if they wish to explore what can be offered from there. If the woman contacts the 
health care centre, they are treated according to the health care centre’s current routines. 
Hence, any education or treatment provided outside the scope of this research project can vary 
between health care centres. Group education and individual education for the other groups 
are provided on top of the primary health care centre’s standard measures. 
Data collection 
The following information is collected at baseline. 
• Demographic data: age, work, education, family situation, hormone treatment, 
cardiovascular disease, stress disorder, cause of healthcare contact (psychological and 
/ or physical) and prior sick leave days. In addition, they are asked if they have visited 
the healthcare centre for the past two months as a patient and, if so, for what (a 
number of standard symptoms can be selected) 
• Blood pressure: blood pressure with electronic blood pressure cuff, if necessary 
manual blood pressure, the mean of two blood pressure is recorded at the time of 
visitation. 
• MRS: measures the occurrence of menopausal symptoms. The questionnaire 
consisting of 11 questions brings together menopause symptoms in three main groups; 
somatic symptoms, urogenital symptoms and mental symptoms. The questionnaire 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
indicates the severity of symptoms on a 5-degree scale. Low incidence of symptoms 
indicates 0 points and high incidence of symptoms 4 points. Total sum, individual 
questions and three subgroups are reported. The instrument has been tested for 
reliability and validity (14). 
• MADRS: investigates the degree of depression and depressive symptoms. The 
questionnaire consists of 9 questions, which are graded on a 6-degree scale where 0 
points indicate a low incidence of symptoms and 6 points indicate a high incidence of 
symptoms and ill health. The instrument has been tested for reliability and validity 
(15). 
• SF-36: examines physical and mental health as well as changes over time. The 
questionnaire consists of 36 multiple-choice questions, divided into eight subdivisions. 
Scores are between 0 - 100, higher value indicates better health experience. The 
instrument has been tested for reliability and validity (16). 
• HAD: investigates the degree of anxiety and depressive symptoms. The form consists 
of 14 questions with seven issues that measure anxiety (HAD-A) and seven issues that 
measure depression (HAD-D) and graded on a 4-degree scale. Each question can yield 
between 0 and 3 points and summed to give a score scale of 0-21 for respective 
anxiety and depressive symptoms. Higher points indicate higher incidence of 
symptoms. The instrument has been tested for reliability and validity (17). 
• s-UMS, self-assessed fatigue syndrome. Identify individuals who have developed or 
may be developing a clinical fatigue syndrome with impaired work ability and 
increased risk of sick leave. The form has four questions with queries. The instrument 
has been tested for reliability and validity (18). 
• PSS-14: Measurement of self-assessed general perceived stress. how often you have 
experienced life as unpredictable, uncontrollable and congestive in the last month. The 
form has fourteen questions. The Swedish translation has shown good internal validity 
(19). 
• AUDIT: self-assessment test for alcohol consumption and consists of ten questions 
divided into three domains: consumption, addiction and alcohol-related injuries. 
Results above the cut-off limit 6 points for women and 8 points for men indicate a 
risky drinking. The instrument has been tested for reliability and validity (20). 
Follow-up of intervention takes place six and twelve months after completion of treatment / 
education. Midwife and district nurse participate in the follow-up. During this visit, follow-up 
of quality of life, mental health, care needs and sick leave is made by the woman filling in the 
same questionnaire as at baseline. 
Data is collected by the research nurse at baseline and six and twelve months after completion 
of education. Returned questionnaires are encoded and code lists will be filed at the R & D 
unit Södra Älvsborg in a locked and fireproof archive for more than ten years. Code key is 
stored separately. Access to the material has project managers and supervisors. Electronic 
stored data is stored on the computer's network device H so it is backed up automatically, not 
on the workstation hard drive. Data is stored on the Västra Götaland region password-
protected computer. Tape and video recordings are not used. 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
Statistical analysis 
Questionnaires are summarized according to manuals. Data is described descriptively with a 
appropriate estimates. The scientific research questions will be analysed by multivariate 
regression where the two interventions GI and PCS, each being an independent variable, is 
entered a two-factor model, where interaction effects between the two interventions is also 
evaluated. Moreover, age becomes an independent confounding variable. A regression is 
made for each outcome measure (each scientific question). The level of significance is set to 
≤0.05. IBM SPSS version 20 or later will be used. 
Sample size estimation 
Sample size estimations are made for research questions 1, 3 and 5. When estimating sample 
size, we assume a significance level of 0.05, power of 0.80 and that we do a two-way test. 
When estimating sample sizes, we use simple group comparison for two independent groups 
with Mann-Whitney's test as surrogate test. 
Research 
question 
Assumptions 
Assumed 
”Effect 
size” 
Number 
required 
1 (primary) 
We assume that the quality of life increases by three 
points in the intervention group and zero points in the 
control group. Furthermore, the standard deviation is 
eight in both groups. 
0,38 
236 
3 
We assume that days on sick leave decrease by two days 
in the intervention group and by 0.5 days in the control 
group. Furthermore, the standard deviation is five days 
in both groups. 
0.30 
368 
5 
In a previous pilot study (13), a decrease of -0.44 (SD 
5.0) in MADRS depression scores was seen in the 
intervention group while increasing +0.10 in the control 
group (SD 4.8). The pilot study had two group events. 
This study has four group events, which we consider to 
be considerably better structured. We assume that the 
depression score decreases by -1.5, everything else is the 
same. 
0,33 
312 
We plan to include a total of 370 women. 
Expected results 
If any of the interventions shows an effect compared to controls it would add a low-cost tool 
for primary health care in the work to improve women’s health. It could also be used 
preventative for women with stress related symptoms before there is a need for frequent visits 
to the primary health care or need for sick leave. 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
 
References 
1. Lytsy P, Larsson K, Anderzen I. Health in women on long-term sick leave because of pain 
or mental illness. International journal of rehabilitation research Internationale Zeitschrift fur 
Rehabilitationsforschung Revue internationale de recherches de readaptation. 2015;38(1):27-
33. 
2. Försäkringskassan. Avslutade sjukfall efter diagnos. . 
http://www.forsakringskassan.se/wps/wcm/connect/3228cb04-e323-40fa-8bf3-
5cffebe0bcf4/socialforsakringsrapport_2009_5.pdf?MOD=AJPERES: 2008. 
3. Nelson HD. Menopause. Lancet. 2008;371(9614):760-70. 
4. Åsberg M GK, Herlofson J, Jacobsson L, Krakau I, Nygren A, Perski A & Svensson A. 
Utmattningssyndrom - en kunskapsöversikt om stressrelaterad psykisk ohälsa. . 
http://www.stressmedicin.com/upload/Regionkanslierna/ISM%20Institutet%20f%C3%B6r%2
0stressmedicin/Publikationer/ISM-h%C3%A4ften/ISM Socialstyrelsen, 2003. 
5. Peterson U, Bergstrom G, Demerouti E, Gustavsson P, Asberg M, Nygren A. Burnout 
levels and self-rated health prospectively predict future long-term sickness absence: a study 
among female health professionals. Journal of occupational and environmental medicine. 
2011;53(7):788-93. 
6. Busch H, Bodin L, Bergstrom G, Jensen IB. Patterns of sickness absence a decade after 
pain-related multidisciplinary rehabilitation. Pain. 2011;152(8):1727-33. 
7. Ayers B, Forshaw M, Hunter MS. The impact of attitudes towards the menopause on 
women's symptom experience: a systematic review. Maturitas. 2010;65(1):28-36. 
8.STRONG Neves ECM, Birkhauser M, Samsioe G, Lambrinoudaki I, Palacios S, Borrego 
RS, et al. EMAS position statement: The ten point guide to the integral management of 
menopausal health. Maturitas. 2015;81(1):88-92. 
9. Kuhmmer R, Lazzaretti RK, Guterres CM, Raimundo FV, Leite LE, Delabary TS, et al. 
Effectiveness of multidisciplinary intervention on blood pressure control in primary health 
care: a randomized clinical trial. BMC health services research. 2016;16:456. 
10. Flode M, Iversen MM, Aarflot M, Haltbakk J. Lasting impact of an implemented self-
management programme for people with type 2 diabetes referred from primary care: a one-
group, before-after design. Scandinavian journal of caring sciences. 2017. 
11. Molarius A, Berglund K, Eriksson C, Eriksson HG, Linden-Bostrom M, Nordstrom E, et 
al. Mental health symptoms in relation to socio-economic conditions and lifestyle factors--a 
population-based study in Sweden. BMC public health. 2009;9:302. 

 
 
 
Närhälsan, Region Västra Götaland, Sweden 
Study protocol: Effect of primary care education on mental health, quality of life, need for sick leave and health 
care consumption in women 45-60 years with stress-related symptoms. A randomized controlled trial. 
12th of September 2018 
Version 6 
12. Arving C, Sjoden PO, Bergh J, Hellbom M, Johansson B, Glimelius B, et al. Individual 
psychosocial support for breast cancer patients: a randomized study of nurse versus 
psychologist interventions and standard care. Cancer nursing. 2007;30(3):E10-9. 
13. Rindner L, Stromme G, Nordeman L, Hange D, Gunnarsson R, Rembeck G. Reducing 
menopausal symptoms for women during the menopause transition using group education in a 
primary health care setting-a randomized controlled trial. Maturitas. 2017;98:14-9. 
14.Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, et al. The 
Menopause Rating Scale (MRS) scale: a methodological review. Health and quality of life 
outcomes. 2004;2:45. 
15. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. 
The British journal of psychiatry : the journal of mental science. 1979;134:382-9. 
16. Taft C, Karlsson J, Sullivan M. Performance of the Swedish SF-36 version 2.0. Quality of 
life research : an international journal of quality of life aspects of treatment, care and 
rehabilitation. 2004;13(1):251-6. 
17. Snaith R P. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 
2003; 1: 29. Published online 2003 Aug. 1. doi: 10.1186/1477-7525-1-29 
18.Glise K, Hadzibajramovic E, Jonsdottir IH, Ahlborg G, Jr. Self-reported exhaustion: a 
possible indicator of reduced work ability and increased risk of sickness absence among 
human service workers. International archives of occupational and environmental health. 
2010;83(5):511-20. 
19. Nordin M, Nordin S. Psychometric evaluation and normative data of the Swedish version 
of the 10-item perceived stress scale. Scandinavian journal of psychology. 2013;54(6):502-7. 
20. Bergman H, Källmén H, Hermansson U. audit–The Alcohol Use Disorders Identification 
Test, manual. Translated and adapted for use in Sweden) Stockholm, Karolinska Institute. 
1994.