DepressionPRIM-CARENCT02378272
Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care
A study testing care manager for depression in people with Depression, run by Göteborg University at 1 site in Sweden.
Trial summary
The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- care manager for depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2014to 31 Dec 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed mild-moderate depression,
- 18 - 80 years,
- attending primary care center
Who cannot join
- schizophrenia,
- abuse/addiction,
- psychosis,
- bipolar syndrome,
- suicidal ideation or earlier suicide attempt,
- ongoing deep depression,
- generalized anxiety syndrome,
- not communicable in Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Primary Health Care, Sahlgrenska Academy
Gothenburg, Region Västra Götaland, 40530
About this study
Official title: RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective compared with the traditional Swedish primary care organization. The aim is also to evaluate the care manager function in a health economic perspective.
The specific aims are to develop and evaluate an evidence-based care manager program for patients with mild to moderate depression and to compare the evidence-based care manager program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of the program on patients' health in relation to the running costs of the program.
Read the detailed description
Methods The research questions will be tested in a randomised controlled trial with follow ups 3 and 6 months in the primary care setting in cooperation between universities of Gothenburg, Karolinska Institute and primary care centres (PCC) of regions/county councils of Västra Götaland, and Dalarna.
Design A cluster randomized controlled trial of two groups (intervention and control). Randomization will be at the level of the primary care centers (PCCs).
Population of study Patients aged 18 and up that visit one of 20 different urban and rural PCCs.
Randomization All PCCs in the participating regions without employed onsite mental health professionals are invited to participate in the study. Around twenty practices will be matched into 10 blocks by depression treatment practices, thereafter 1 practice from each block will be randomly assigned to receive the care manager intervention program.
Intervention At the intervention practices, a district nurse will apply around 15-25% of working time as care coordinator for management of care for the patients with depression. Before patient recruitment begins, physicians and the nurse/district nurse (care manager) will participate in sessions for training in providing clinical services (patient information and education on patient's preferred treatment, assessment of patient's depressive symptoms and regular telephone contacts, follow up visits etc).
Recruitment of patients and Data collection Patients aged 18 and up that visit primary health care centres and are diagnosed by the General Practitioner (GP) with light/medium depression disorder according to PRIME-MD (4). The patients will be monitored up to 6 months after inclusion in the study by an individual interview (first visit, 3 and 6 months).
All parameters will be assessed at baseline and 3 and 6 months; prescription of antidepressants, number of days of labour lost, socio-demographic and economic variables, alcohol consumption, physical activity, and ethnicity. BDI-II, EuroQoL-5D, Work Ability Instrument (WAI) Karasek Job strain Model , medication, other treatment (psychological, counselling, or other).
For somatic health reasons, also blood pressure and p-glucose will be monitored, and blood samples for bio-bank storage.
Outcome criteria Change in: depression symptoms (BDI-II), work ability index (WAI), Job strain (Karasek), EQ-5D, QALYs from baseline to 3 and 6 months. Amount of sick listing (days, %), days of labour lost.
Statistical analysis Analysis of covariance, controlling for baseline value, will be used to estimate the overall treatment effectiveness (difference in score) at final follow-up. Subgroup analysis by gender as well as age adjustments will also be performed.
Power calculation The primary variable is the level of depression (as measured by the BDI-II) and analyzed in an ANCOVA model with repeated measures. In order to detect an effect of 3 units in the difference between the two groups, with a power of 80% and a significance level of 10% (two-sided) about 200 patients is needed in each group (9). The underlying assumption is a standard deviation in the group of 10 units, a within-subject correlation of 0.4, and a within-cluster-correlation of 0.1, i.e. a design effect of 1.9 to correct for having a cluster analysis.
Cost-effectiveness analysis A cost- effectiveness analysis (CEA) with quality-adjusted life years (QALY) as measure of effect will be performed.
The region Västra Götaland has proclaimed interest in the study, and financially supports the study.
- Conditions
- Depression
- Being tested
- care manager for depression
- Keywords
- Care Manager, Primary Care, Depressive symptoms, quality of life, return to work
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care manager for depressionOther
District nurse (care manager for depression) providing clinical services ( in cooperation with GP) as patient information and education on patient's preferred treatment, development of care plan, assessment of patient's depressive symptoms and regular telephone contacts.
| Study group | Role | What they receive |
|---|---|---|
| Care manager for depression | Experimental | A district nurse will apply around 15-25% of working time as care coordinator (care manager for depression) at PCC for management of care for all recruited patients with depression Receives: Other: care manager for depression |
| Treatment As Usual | No intervention | Management of recruited patients with depression continued as usually applied at PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)
Self-reported level of depressive symptoms measured by Beck Depression Inventory II
Measured: 0- 6 months
Secondary outcomes (4)
Sick-listing (Amount of sick-listing days during 0-6 months observation period)
Amount of sick-listing days during 0-6 months observation period
Measured: 6 months
Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model)
Perception of job strain measured by Karasek Job Strain Model
Measured: 0-6 months
Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D)
Self-reported level of perceived Quality of Life measured by EQ-5D
Measured: 0- 6 months
Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index)
Self-reported level of perceived work ability measured by Work Ability Index
Measured: 0 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion31 Jan 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Björkelund, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378272
- Sponsor's protocol ID
- RS 1938-2013
- Acronym
- PRIM-CARE
- Status last verified
- Sep 2023
- First submitted
- 2 Feb 2015
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjorkelund C, Svenningsson I, Hange D, Udo C, Petersson EL, Ariai N, Nejati S, Wessman C, Wikberg C, Andre M, Wallin L, Westman J. Clinical effectiveness of care managers in collaborative care for patients with depression in Swedish primary health care: a pragmatic cluster randomized controlled trial. BMC Fam Pract. 2018 Feb 9;19(1):28. doi: 10.1186/s12875-018-0711-z.
PubMed 29426288Holst A, Ginter A, Bjorkelund C, Hange D, Petersson EL, Svenningsson I, Westman J, Andre M, Wikberg C, Wallin L, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study. BMJ Open. 2018 Nov 12;8(11):e024741. doi: 10.1136/bmjopen-2018-024741.
PubMed 30420353Petersson EL, Hange D, Udo C, Bjorkelund C, Svenningsson I. Long-term effect of a care manager on work ability for patients with depression - the PRIM-CARE RCT. Work. 2022;72(2):601-609. doi: 10.3233/WOR-205272.
PubMed 35527596Holst A, Labori F, Bjorkelund C, Hange D, Svenningsson I, Petersson EL, Westman J, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: 12-month economic evaluation of a pragmatic randomised controlled trial. Cost Eff Resour Alloc. 2021 Aug 17;19(1):52. doi: 10.1186/s12962-021-00304-5.
PubMed 34404426Af Winklerfelt Hammarberg S, Bjorkelund C, Nejati S, Magnil M, Hange D, Svenningsson I, Petersson EL, Andre M, Udo C, Ariai N, Wallin L, Wikberg C, Westman J. Clinical effectiveness of care managers in collaborative primary health care for patients with depression: 12- and 24-month follow-up of a pragmatic cluster randomized controlled trial. BMC Prim Care. 2022 Aug 9;23(1):198. doi: 10.1186/s12875-022-01803-x.
PubMed 35945493Augustsson P, Petersson EL, Bjorkelund C, Persson Kylen S, Wikberg C. Organisational and social work-environment experiences after care manager implementation: a repeated cross-sectional study in Swedish primary care. Scand J Prim Health Care. 2026 Dec;44(1):1-12. doi: 10.1080/02813432.2025.2538486. Epub 2025 Jul 28.
PubMed 40726123Svenningsson I, Hange D, Udo C, Tornbom K, Bjorkelund C, Petersson EL. The care manager meeting the patients' unique needs using the care manager model-A qualitative study of experienced care managers. BMC Fam Pract. 2021 Sep 3;22(1):175. doi: 10.1186/s12875-021-01523-8.
PubMed 34474682Svenningsson I, Petersson EL, Udo C, Westman J, Bjorkelund C, Wallin L. Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression. BMC Fam Pract. 2019 Jul 27;20(1):108. doi: 10.1186/s12875-019-0998-4.
PubMed 31351444
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
- ClinicalTrials.gov ID
- NCT02378272
- Acronym / sponsor ID
- PRIM-CARE / RS 1938-2013
- Conditions
- Depression
- Keywords
- Care Manager, Primary Care, Depressive symptoms, quality of life, return to work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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.
The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective compared with the traditional Swedish primary care organization. The aim is also to evaluate the care manager function in a health economic perspective.
The specific aims are to develop and evaluate an evidence-based care manager program for patients with mild to moderate depression and to compare the evidence-based care manager program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of the program on patients' health in relation to the running costs of the program.
Detailed description
Methods The research questions will be tested in a randomised controlled trial with follow ups 3 and 6 months in the primary care setting in cooperation between universities of Gothenburg, Karolinska Institute and primary care centres (PCC) of regions/county councils of Västra Götaland, and Dalarna.
Design A cluster randomized controlled trial of two groups (intervention and control). Randomization will be at the level of the primary care centers (PCCs).
Population of study Patients aged 18 and up that visit one of 20 different urban and rural PCCs.
Randomization All PCCs in the participating regions without employed onsite mental health professionals are invited to participate in the study. Around twenty practices will be matched into 10 blocks by depression treatment practices, thereafter 1 practice from each block will be randomly assigned to receive the care manager intervention program.
Intervention At the intervention practices, a district nurse will apply around 15-25% of working time as care coordinator for management of care for the patients with depression. Before patient recruitment begins, physicians and the nurse/district nurse (care manager) will participate in sessions for training in providing clinical services (patient information and education on patient's preferred treatment, assessment of patient's depressive symptoms and regular telephone contacts, follow up visits etc).
Recruitment of patients and Data collection Patients aged 18 and up that visit primary health care centres and are diagnosed by the General Practitioner (GP) with light/medium depression disorder according to PRIME-MD (4). The patients will be monitored up to 6 months after inclusion in the study by an individual interview (first visit, 3 and 6 months).
All parameters will be assessed at baseline and 3 and 6 months; prescription of antidepressants, number of days of labour lost, socio-demographic and economic variables, alcohol consumption, physical activity, and ethnicity. BDI-II, EuroQoL-5D, Work Ability Instrument (WAI) Karasek Job strain Model , medication, other treatment (psychological, counselling, or other).
For somatic health reasons, also blood pressure and p-glucose will be monitored, and blood samples for bio-bank storage.
Outcome criteria Change in: depression symptoms (BDI-II), work ability index (WAI), Job strain (Karasek), EQ-5D, QALYs from baseline to 3 and 6 months. Amount of sick listing (days, %), days of labour lost.
Statistical analysis Analysis of covariance, controlling for baseline value, will be used to estimate the overall treatment effectiveness (difference in score) at final follow-up. Subgroup analysis by gender as well as age adjustments will also be performed.
Power calculation The primary variable is the level of depression (as measured by the BDI-II) and analyzed in an ANCOVA model with repeated measures. In order to detect an effect of 3 units in the difference between the two groups, with a power of 80% and a significance level of 10% (two-sided) about 200 patients is needed in each group (9). The underlying assumption is a standard deviation in the group of 10 units, a within-subject correlation of 0.4, and a within-cluster-correlation of 0.1, i.e. a design effect of 1.9 to correct for having a cluster analysis.
Cost-effectiveness analysis A cost- effectiveness analysis (CEA) with quality-adjusted life years (QALY) as measure of effect will be performed.
The region Västra Götaland has proclaimed interest in the study, and financially supports the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care manager for depression | Experimental | Other: care manager for depressionA district nurse will apply around 15-25% of working time as care coordinator (care manager for depression) at PCC for management of care for all recruited patients with depression |
| Treatment As Usual | No intervention | –Management of recruited patients with depression continued as usually applied at PCC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed mild-moderate depression,
- 18 - 80 years,
- attending primary care center
Key exclusion criteria (8 listed)
- schizophrenia,
- abuse/addiction,
- psychosis,
- bipolar syndrome,
- suicidal ideation or earlier suicide attempt,
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 |
|---|---|---|
| care manager for depressionDistrict nurse (care manager for depression) providing clinical services ( in cooperation with GP) as patient information and education on patient's preferred treatment, development of care plan, assessment of patient's depressive symptoms and regular telephone contacts. | Other | Care manager for depression |
Primary outcome
Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)
Time frame: 0- 6 months
Self-reported level of depressive symptoms measured by Beck Depression Inventory II
4 secondary outcomes
Sick-listing (Amount of sick-listing days during 0-6 months observation period)
Time frame: 6 months
Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model)
Time frame: 0-6 months
Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D)
Time frame: 0- 6 months
Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index)
Time frame: 0 - 6 months
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 21 Sep 2023.
- Results publication: PubMed 29426288Bjorkelund C, Svenningsson I, Hange D, Udo C, Petersson EL, Ariai N, Nejati S, Wessman C, Wikberg C, Andre M, Wallin L, Westman J. Clinical effectiveness of care managers in collaborative care for patients with depression in Swedish primary health care: a pragmatic cluster randomized controlled trial. BMC Fam Pract. 2018 Feb 9;19(1):28. doi: 10.1186/s12875-018-0711-z.
- Results publication: PubMed 30420353Holst A, Ginter A, Bjorkelund C, Hange D, Petersson EL, Svenningsson I, Westman J, Andre M, Wikberg C, Wallin L, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study. BMJ Open. 2018 Nov 12;8(11):e024741. doi: 10.1136/bmjopen-2018-024741.
- Results publication: PubMed 35527596Petersson EL, Hange D, Udo C, Bjorkelund C, Svenningsson I. Long-term effect of a care manager on work ability for patients with depression - the PRIM-CARE RCT. Work. 2022;72(2):601-609. doi: 10.3233/WOR-205272.
- Results publication: PubMed 34404426Holst A, Labori F, Bjorkelund C, Hange D, Svenningsson I, Petersson EL, Westman J, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: 12-month economic evaluation of a pragmatic randomised controlled trial. Cost Eff Resour Alloc. 2021 Aug 17;19(1):52. doi: 10.1186/s12962-021-00304-5.
- Results publication: PubMed 35945493Af Winklerfelt Hammarberg S, Bjorkelund C, Nejati S, Magnil M, Hange D, Svenningsson I, Petersson EL, Andre M, Udo C, Ariai N, Wallin L, Wikberg C, Westman J. Clinical effectiveness of care managers in collaborative primary health care for patients with depression: 12- and 24-month follow-up of a pragmatic cluster randomized controlled trial. BMC Prim Care. 2022 Aug 9;23(1):198. doi: 10.1186/s12875-022-01803-x.
- Derived from this study: PubMed 40726123Augustsson P, Petersson EL, Bjorkelund C, Persson Kylen S, Wikberg C. Organisational and social work-environment experiences after care manager implementation: a repeated cross-sectional study in Swedish primary care. Scand J Prim Health Care. 2026 Dec;44(1):1-12. doi: 10.1080/02813432.2025.2538486. Epub 2025 Jul 28.
- Derived from this study: PubMed 34474682Svenningsson I, Hange D, Udo C, Tornbom K, Bjorkelund C, Petersson EL. The care manager meeting the patients' unique needs using the care manager model-A qualitative study of experienced care managers. BMC Fam Pract. 2021 Sep 3;22(1):175. doi: 10.1186/s12875-021-01523-8.
- Derived from this study: PubMed 31351444Svenningsson I, Petersson EL, Udo C, Westman J, Bjorkelund C, Wallin L. Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression. BMC Fam Pract. 2019 Jul 27;20(1):108. doi: 10.1186/s12875-019-0998-4.
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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.
Cecilia Björkelund principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care manager for depression in people with Depression, run by Göteborg University 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 3 inclusion and 8 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 21 Sep 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?
Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II) (time frame: 0- 6 months). 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 NCT02378272, which also lists 8 linked publications.
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 21 Sep 2023.