Women's HealthNCT03663075
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
A study testing Group information (GI) and Structured person-centered support (PCS) in people with Women's Health and Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Women's Health, Quality of Life, Mental Health
- What is being tested?
- Group information (GI) and Structured person-centered support (PCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSweden
- Study dates
- 24 Sep 2018to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- The woman do not wish to continue participation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Research and Development Unit
Borås, Västra Götaland County, 503 38
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Women's Health, Quality of Life, Mental Health, Menopause, Primary Health Care, Sick Leave
- Being tested
- Group information (GI), Structured person-centered support (PCS)
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group information (GI)Behavioural
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.
Structured person-centered support (PCS)Behavioural
The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group will receive the intervention Group information (GI). Receives: Behavioral: Group information (GI) |
| Group 2 | Experimental | This group will receive the intervention Group information (GI) followed by Structured person-centered support (PCS) Receives: Behavioral: Group information (GI); Behavioral: Structured person-centered support (PCS) |
| Group 3 | Experimental | This group will receive the intervention Structured person-centered support (PCS) Receives: Behavioral: Structured person-centered support (PCS) |
| Group 4 | No intervention | This is a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.)
Measured: Change from baseline to six months after completed intervention
Short term effect of Structured person-centered support (PCS) on change in depressive mood
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)
Measured: Change from baseline to six months after completed intervention
Short term effect of Structured person-centered support (PCS) on change in quality of life
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)
Measured: Change from baseline to six months after completed intervention
Short term effect of Structured person-centered support (PCS) on stress levels
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)
Measured: Change from baseline to six months after completed intervention
Short term effect of group education (GI) on change in days on sick leave
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.)
Measured: Change from baseline to six months after completed intervention
Short term effect of group education (GI) on change in depressive mood
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)
Measured: Change from baseline to six months after completed intervention
Short term effect of group education (GI) on stress levels
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).
Measured: Change from baseline to six months after completed intervention
Long term effect of Structured person-centered support (PCS) on change in days on sick leave
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.)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of Structured person-centered support (PCS) on change in depressive mood
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)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of Structured person-centered support (PCS) on change in quality of life
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)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of Structured person-centered support (PCS) on stress levels
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)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of group education (GI) on change in days on sick leave
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.)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of group education (GI) on change in depressive mood
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)
Measured: Change from baseline to 12 months after completed intervention
Long 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 12 months after completed intervention)
Measured: Change from baseline to 12 months after completed intervention
Long term effect of group education (GI) on stress levels
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).
Measured: Change from baseline to 12 months after completed intervention
Short term effect of group education (GI) on levels of anxiety
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).
Measured: Change from baseline to 6 months after completed intervention
Long term effect of group education (GI) on levels of anxiety
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).
Measured: Change from baseline to 12 months after completed intervention
Short term effect of Structured person-centered support (PCS) on levels of anxiety
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).
Measured: Change from baseline to 6 months after completed intervention
Long term effect of Structured person-centered support (PCS) on levels of anxiety
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).
Measured: Change from baseline to 12 months after completed intervention
Short term effect of Structured person-centered support (PCS) on visits to primary health care
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).
Measured: Change from baseline to 6 months after completed intervention
Long term effect of Structured person-centered support (PCS) on visits to primary health care
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).
Measured: Change from baseline to 12 months after completed intervention
Short term effect of group education (GI) on visits to primary health care
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).
Measured: Change from baseline to 6 months after completed intervention
Long term effect of group education (GI) on visits to primary health care
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).
Measured: Change from baseline to 12 months after completed intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start24 Sep 2018
- Primary completion26 Feb 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two factor design evaluating two separate treatment modalities
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Lena Rindner, Principal investigator, Vastra Gotaland region, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663075
- Sponsor's protocol ID
- U1111-1219-6542
- Status last verified
- Nov 2020
- First submitted
- 29 Aug 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The descriptive data provided will be summary data for each group. The investigators will not show data from single participants.
Publications
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.
PubMed 36964526
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03663075
- Acronym / sponsor ID
- U1111-1219-6542
- Conditions
- Women's Health, Quality of Life, Mental Health, Menopause, Primary Health Care, Sick Leave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two factor design evaluating two separate treatment modalities
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Group information (GI)This group will receive the intervention Group information (GI). |
| Group 2 | Experimental | Behavioral: Group information (GI), Behavioral: Structured person-centered support (PCS)This group will receive the intervention Group information (GI) followed by Structured person-centered support (PCS) |
| Group 3 | Experimental | Behavioral: Structured person-centered support (PCS)This group will receive the intervention Structured person-centered support (PCS) |
| Group 4 | No intervention | –This is a control group. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- The woman do not wish to continue participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 1, Group 2 |
| 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. | Behavioural | Group 2, Group 3 |
Primary outcome
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)
23 secondary outcomes
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
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
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
Short term effect of Structured person-centered support (PCS) on stress levels
Time frame: Change from baseline to six months after completed intervention
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
Short term effect of group education (GI) on change in depressive mood
Time frame: Change from baseline to six months after completed intervention
Short term effect of group education (GI) on stress levels
Time frame: Change from baseline to six months after completed intervention
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
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
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
Long term effect of Structured person-centered support (PCS) on stress levels
Time frame: Change from baseline to 12 months after completed intervention
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
Long term effect of group education (GI) on change in depressive mood
Time frame: Change from baseline to 12 months after completed intervention
Long term effect of group education (GI) on change in quality of life
Time frame: Change from baseline to 12 months after completed intervention
Long term effect of group education (GI) on stress levels
Time frame: Change from baseline to 12 months after completed intervention
Short term effect of group education (GI) on levels of anxiety
Time frame: Change from baseline to 6 months after completed intervention
Long term effect of group education (GI) on levels of anxiety
Time frame: Change from baseline to 12 months after completed intervention
Short term effect of Structured person-centered support (PCS) on levels of anxiety
Time frame: Change from baseline to 6 months after completed intervention
Long term effect of Structured person-centered support (PCS) on levels of anxiety
Time frame: Change from baseline to 12 months after completed intervention
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
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
Short term effect of group education (GI) on visits to primary health care
Time frame: Change from baseline to 6 months after completed intervention
Long term effect of group education (GI) on visits to primary health care
Time frame: Change from baseline to 12 months after completed intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 36964526Rindner 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.
- Individual participant dataSharing planned: No. The descriptive data provided will be summary data for each group. The investigators will not show data from single participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Rindner principal investigator
Vastra Gotaland region, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group information (GI) and Structured person-centered support (PCS) in people with Women's Health and Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term effect of group education (GI) on change in quality of life (time frame: Change from baseline to six months after completed intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.