The Effects of Primary Care Behavioral Health in Primary Care in Sweden
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Östergötland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Implementation of the service delivery model primary care behavioral health
BehavioralThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: ImplementationExperimental treatment 1 intervention
Group B: No implementationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to 24 months.2
Functional level of the patients.
Measured by Sheehan disability scale.
Time frame
Baseline to 24 months.3
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.
Time frame
Baseline to 24 months.4
Experience of primary care behavioral health among the medical staff
Data will be collected through qualitative interviews.
Time frame
Baseline to 24 months.Secondary outcomes
1
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).
Time frame
In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.2
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.
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).3
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.
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).4
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov