Primary Health CareNCT05633940
The Effects of Primary Care Behavioral Health in Primary Care in Sweden
A study testing Implementation of the service delivery model primary care behavioral health in people with Primary Health Care and Mental Disorder, run by Region Östergötland at 1 site in Sweden.
Trial summary
The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Health Care, Mental Disorder, Behavioral Symptoms
- What is being tested?
- Implementation of the service delivery model primary care behavioral health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who seek care for mental health problems at a participating centre,
- Adult patients who have received any following International Classification of Diseases diagnose: F00-F99, Z56, Z73
- Adult patients who are prescribed any psychotropic drugs with ATC codes: N05A-C, N06A) at a participating centre.
- Adult patients who has an appointment to a behavioral health consultant at a participating centre.
- Health care professionals employed at a participating centre.
Who cannot join
- Not capable to leave informed consent.
- Medical staff:
- Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Primärvårdscentrum
Linköping, Östergötland County, 582 25
Hanna I Larsen, PhD, +46101044207, hanna.israelsson.larsen@regionostergotland.se
Eva Anskär, Med. Lic., +46705654329, Eva.Anskar@regionostergotland.se
About this study
The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.
Read the detailed description
Psychosocial and mental health problems is a growing public health concern and challenge for primary care where resources are scarce. The multi-professional novel service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care. The model offer high accessibility to brief interventions, is clinically intuitively attractive and has been disseminated in primary care organizations globally, as well as in Sweden. However, more research is needed on its effect and implementation in routine care. The objective is to investigate the effect of the new service delivery model PCBH on organization- staff- and patient outcomes, and to investigate the implementation of PCBH in terms of how and to which degree the new way of working is normalised in practice routines. This multicenter mixed-methods interventional study is designed as a controlled pragmatic clinical trial. The effect of PCBH will be investigated on organizational, staff and patient levels. Variables include waiting lists, symptoms, medication prescriptions, quality of life and working environment aspects. Study participants will be patients, staff and managers at the included primary care centers. Implementation of PCBH will be investigated regarding the implementation process and degree of implementation. Data will be both qualitative (individual interviews) and quantitative (registers, biomarkers and questionnaires). At least 24 intervention centers will be compared to an equal number of control centers. The research project will be conducted in several regions in Sweden during a period of 4 years. PCBH seems to offer a solution the challenges in modern primary care, but evidence is low. This study will provide much-needed clinically meaningful data regarding PCBH that hopefully could be used for future development of primary healthcare.
- Conditions
- Primary Health Care, Mental Disorder, Behavioral Symptoms
- Being tested
- Implementation of the service delivery model primary care behavioral health
- Medical subject headings
- Mental Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the service delivery model primary care behavioral healthBehavioural
The research project will study a real-world implementation of PCBH in routine primary care. The implementation is facilitated by a regional implementation group of psychologists with special training in PCBH. The active implementation period for each intervention center is 12 months, where continuous support, materials and training are offered by the implementation group.
| Study group | Role | What they receive |
|---|---|---|
| Implementation | Experimental | The centers that implement PCBH. Receives: Behavioral: Implementation of the service delivery model primary care behavioral health |
| No implementation | No intervention | Control centers that do not implement PCBH. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessibility at the health care center, measured in number of visits
Number of visits to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).
Measured: Baseline to 24 months.
Functional level of the patients.
Measured by Sheehan disability scale.
Measured: Baseline to 24 months.
Work environment among the medical staff
Measured by the COPSOQ III questionnaire , which is an instrument that measures psychosocial factors, stress, and the well-being of employees.
Measured: Baseline to 24 months.
Experience of primary care behavioral health among the medical staff
Data will be collected through qualitative interviews.
Measured: Baseline to 24 months.
Secondary outcomes (10)
Accessibility at the health care center, measured in waiting times.
Waiting times to first visit to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).
Measured: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Quality of life of the patients.
Measured by Euroqol 5 dimensions 5 levels, on a scale from 1 to 5 on each item where 1 means no problems and 5 means severe problems.
Measured: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of anxiety in the patients.
Measured by Generalised Anxiety Disorder Assessment (GAD-7), on a scale from 0-21, where higher points means higher risk for anxiety.
Measured: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of depression in the patients
Measured by the patient health questionnaire (PHQ-9) on a scale from 0-27, where higher points means higher risk for depression.
Measured: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Referrals to psychiatric care
The number of patients with mental health issues who are referred to psychiatric specialist care.
Measured: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Work commitment among the medical staff
Measured by the Utrecht Work Engagement Scale, where higher points mean higher work engagement.
Measured: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Exhaustion among the medical staff
Measured by the Karolinska exhaustion disorder scale (KEDS), where higher points indicate higher risk for exhaustion disorder.
Measured: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Fidelity to the core components among the medical staff
Measured by a questionnaire incorporating typical features of work according to primary care behavioral health.
Measured: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Medical treatment of patients due to mental health issues
Number of patients who are prescribed psychotropic drugs (ATC codes: N05A, N05B, N05C and N06A).
Measured: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Sick leave of patients due to mental health issues
Number of patients who are on sick leave due to mental health issues (defined as sick leave due to one or more F- or Z-diagnoses according to the International Classification of Diseases (ICD-10) codes in the F00-F99, Z56, Z63 and Z73 sections.
Measured: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County, Region Örebro County
- Responsible party
- Principal investigator, Hanna Israelsson Larsen, Region Östergötland
- Investigators
- Hanna I Larsen, PhD, Principal investigator, region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633940
- Sponsor's protocol ID
- 2020-05572
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not planned to be shared with other researchers.
Publications
Nordgren LB, Thomas K, Ruiz ES, Koshnaw K, Fredriksson M, Nilsen P, Larsen HI. Implementing the Primary Care Behavioral Health model into routine practice in Swedish primary care: a pilot trial. BMC Health Serv Res. 2026 Sep 3;26(1):1237. doi: 10.1186/s12913-026-15452-8.
PubMed 42706525Larsen HI, Thomas K, Nordgren LB, Ruiz ES, Koshnaw K, Nilsen P. Implementing primary care behavioral health in Swedish primary care - study protocol for a pragmatic stepped wedge cluster trial. BMC Prim Care. 2024 Aug 20;25(1):310. doi: 10.1186/s12875-024-02515-0.
PubMed 39164634
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Primary Care Behavioral Health in Primary Care in Sweden
- ClinicalTrials.gov ID
- NCT05633940
- Acronym / sponsor ID
- 2020-05572
- Conditions
- Primary Health Care, Mental Disorder, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Region Jönköping County, Region Örebro County
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Dec 2022 (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.
The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.
Detailed description
Psychosocial and mental health problems is a growing public health concern and challenge for primary care where resources are scarce. The multi-professional novel service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care. The model offer high accessibility to brief interventions, is clinically intuitively attractive and has been disseminated in primary care organizations globally, as well as in Sweden. However, more research is needed on its effect and implementation in routine care. The objective is to investigate the effect of the new service delivery model PCBH on organization- staff- and patient outcomes, and to investigate the implementation of PCBH in terms of how and to which degree the new way of working is normalised in practice routines. This multicenter mixed-methods interventional study is designed as a controlled pragmatic clinical trial. The effect of PCBH will be investigated on organizational, staff and patient levels. Variables include waiting lists, symptoms, medication prescriptions, quality of life and working environment aspects. Study participants will be patients, staff and managers at the included primary care centers. Implementation of PCBH will be investigated regarding the implementation process and degree of implementation. Data will be both qualitative (individual interviews) and quantitative (registers, biomarkers and questionnaires). At least 24 intervention centers will be compared to an equal number of control centers. The research project will be conducted in several regions in Sweden during a period of 4 years. PCBH seems to offer a solution the challenges in modern primary care, but evidence is low. This study will provide much-needed clinically meaningful data regarding PCBH that hopefully could be used for future development of primary healthcare.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation | Experimental | Behavioral: Implementation of the service delivery model primary care behavioral healthThe centers that implement PCBH. |
| No implementation | No intervention | –Control centers that do not implement PCBH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients who seek care for mental health problems at a participating centre,
- Adult patients who have received any following International Classification of Diseases diagnose: F00-F99, Z56, Z73
- Adult patients who are prescribed any psychotropic drugs with ATC codes: N05A-C, N06A) at a participating centre.
- Adult patients who has an appointment to a behavioral health consultant at a participating centre.
- Health care professionals employed at a participating centre.
Key exclusion criteria (3 listed)
- Not capable to leave informed consent.
- Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.
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 |
|---|---|---|
| Implementation of the service delivery model primary care behavioral healthThe research project will study a real-world implementation of PCBH in routine primary care. The implementation is facilitated by a regional implementation group of psychologists with special training in PCBH. The active implementation period for each intervention center is 12 months, where continuous support, materials and training are offered by the implementation group. | Behavioural | Implementation |
Primary outcome
Accessibility at the health care center, measured in number of visits
Time frame: Baseline to 24 months.
Number of visits to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).
Functional level of the patients.
Time frame: Baseline to 24 months.
Measured by Sheehan disability scale.
Work environment among the medical staff
Time frame: Baseline to 24 months.
Measured by the COPSOQ III questionnaire , which is an instrument that measures psychosocial factors, stress, and the well-being of employees.
Experience of primary care behavioral health among the medical staff
Time frame: Baseline to 24 months.
Data will be collected through qualitative interviews.
10 secondary outcomes
Accessibility at the health care center, measured in waiting times.
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Quality of life of the patients.
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of anxiety in the patients.
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of depression in the patients
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Referrals to psychiatric care
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Work commitment among the medical staff
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Exhaustion among the medical staff
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Fidelity to the core components among the medical staff
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Medical treatment of patients due to mental health issues
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Sick leave of patients due to mental health issues
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 42706525Nordgren LB, Thomas K, Ruiz ES, Koshnaw K, Fredriksson M, Nilsen P, Larsen HI. Implementing the Primary Care Behavioral Health model into routine practice in Swedish primary care: a pilot trial. BMC Health Serv Res. 2026 Sep 3;26(1):1237. doi: 10.1186/s12913-026-15452-8.
- Derived from this study: PubMed 39164634Larsen HI, Thomas K, Nordgren LB, Ruiz ES, Koshnaw K, Nilsen P. Implementing primary care behavioral health in Swedish primary care - study protocol for a pragmatic stepped wedge cluster trial. BMC Prim Care. 2024 Aug 20;25(1):310. doi: 10.1186/s12875-024-02515-0.
- Individual participant dataSharing planned: No. IPD are not planned to be shared with other researchers.
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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.
Hanna I Larsen, PhD principal investigator
region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of the service delivery model primary care behavioral health in people with Primary Health Care and Mental Disorder, run by Region Östergötland 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 3 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: looking for participants now, as of the sponsor's last update on 23 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna I Larsen, PhD (0046101044207, hanna.israelsson.larsen@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accessibility at the health care center, measured in number of visits (time frame: Baseline to 24 months.). The study lists 4 primary outcomes in all. 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 NCT05633940, which also lists 2 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 23 Apr 2024.