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NCT Number: NCT05633940

The Effects of Primary Care Behavioral Health in Primary Care in Sweden

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.

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Key information

Conditions

Primary Health Care Behavior Behavioral Symptoms Mental Disorder Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primärvårdscentrum

Linköping, Östergötland County, 582 25, Sweden

Location status: Recruiting

Location contact

Eva Anskär, Med. Lic.

CONTACT

[email protected]

+46705654329

Hanna I Larsen, PhD

CONTACT

[email protected]

+46101044207

Kristin Thomas, PhD

SUB_INVESTIGATOR

Lise Bergman-Nordgren, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients:

Inclusion criteria

, one of following:

  • 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.

Exclusion criteria

  • Not capable to leave informed consent.

Medical staff:

Inclusion criteria

  • Health care professionals employed at a participating centre.

Exclusion criteria

  • Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.

Treatment and study plan

Implementation of the service delivery model primary care behavioral health

Behavioral

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.

Primary outcomes

  1. 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).

  2. Functional level of the patients.

    Time frame: Baseline to 24 months.

    Measured by Sheehan disability scale.

  3. 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.

  4. Experience of primary care behavioral health among the medical staff

    Time frame: Baseline to 24 months.

    Data will be collected through qualitative interviews.

Secondary outcomes

  1. 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.

    Waiting times to first visit to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).

  2. 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).

    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.

  3. 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).

    Measured by Generalised Anxiety Disorder Assessment (GAD-7), on a scale from 0-21, where higher points means higher risk for anxiety.

  4. 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).

    Measured by the patient health questionnaire (PHQ-9) on a scale from 0-27, where higher points means higher risk for depression.

  5. Referrals to psychiatric care

    Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.

    The number of patients with mental health issues who are referred to psychiatric specialist care.

  6. Work commitment among the medical staff

    Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.

    Measured by the Utrecht Work Engagement Scale, where higher points mean higher work engagement.

  7. Exhaustion among the medical staff

    Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.

    Measured by the Karolinska exhaustion disorder scale (KEDS), where higher points indicate higher risk for exhaustion disorder.

  8. Fidelity to the core components among the medical staff

    Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.

    Measured by a questionnaire incorporating typical features of work according to primary care behavioral health.

  9. 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.

    Number of patients who are prescribed psychotropic drugs (ATC codes: N05A, N05B, N05C and N06A).

  10. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Anskär, Med. Lic.

CONTACT

[email protected]

0046705654329

Hanna I Larsen, PhD

CONTACT

[email protected]

0046101044207

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Collaborators

  • Region Jönköping County
  • Region Örebro County

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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