Implementation and Evaluation of Primary Care Behavioral Health in Sweden

NCT ID: NCT05335382

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-06-30

Brief Summary

In this multicenter study, the investigators want to compare treatment outcomes for patients with mental and behavioral health problems in traditional primary care (Care As Usual, CAU) and primary care centres that work according to the Primary Care Behavioral Health (PCBH) model. In addition to this, the investigators want to study organisation-level outcomes, such as access to care, perceived teamwork and work environment. To achieve this, primary care centres that have expressed interest in implementing PCBH will be cluster randomised between implementing directly or waiting for implementation.

Detailed Description

The overarching goal of primary care is to offer all patients individualised and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that a large proportion of patients suffer from mental and behavioural health problems, alone or in combination with one or several chronic illnesses. Despite many patients needing psychosocial interventions, there is a lack of mental health professionals as well as clear pathways for these patients.

Primary Care Behavioral Health (PCBH) is an innovative way of organising primary care, where mental health professionals have more yet shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients achieve relevant behavioral changes, so called brief interventions are used, which are based on isolated components from psychological treatments such as Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Brief interventions usually stretch over 1-4 treatment sessions. Assessments within the model are generally contextual and largely avoid psychiatric diagnostics, instead focusing on the patient's situation and their associated coping strategies - whether they be positive or negative. Although PCBH is gaining in popularity, recent reviews conclude that among the evaluation trials there are very few comparative studies. As such, there is a great need for proper evaluation of a method that is already widely implemented.

Data will be collected at 17 primary care centers (PCCs) in Västra Götalandsregionen, Sweden, that have expressed an interest in implementing PCBH. The study is looking at both patient and organizational level variables. The PCCs will be randomized between implementing PCBH immediately (December 2021) or delayed with 5-9 months (implementation in late spring or early autumn of 2022). Outcome data will be collected also from the PCCs waiting for implementation, while they apply Care as Usual (CAU). Collection of patient self-ratings will start before the first implementation of PCBH to ensure functional data collection routines and possibly create a longer baseline, but the main analysis will use data from the period from when PCCs in the Early implementation arm actually have implemented PCBH to a good enough level and until PCCs in the control group start their implementation. Data from all PCCs will be continuously be collected also during the period when the delayed group implements PCBH. For individual patients, the primary end-point for the primary outcome (everyday functioning) will be 12 weeks after the first visit. Patient outcomes are also measured after 1 year.

Outcome at the organizational level will be measured in several ways, and here the primary outcome will be two measures of waiting time between identification of patient (i.e. them self-referring for mental or behavioral health issues) and the first visit: (a) actual waiting-time and (b) Outcome at the organizational level will be measured in several ways, and here the primary outcome will be two measures of waiting time between identification of patient (i.e. them self-referring for mental or behavioral health issues) and the first visit: (a) actual waiting-time for each patient identified as relevant for inclusion and (b) Third Next Available Appointment (TNAA) for the PCC as a whole, measured at the same day and time each week.

Fidelity will be measured by an expert group as well as using four questionnaires, one for each of mental health professionals, medical doctors, registered nurses and leadership. Implementation data will also be collected from these professional groups/roles at the implementing PCCs, for example with the s-NoMAD questionnaire.

During the implementation process, all psychosocial resources (all relevant psychologists, social workers, psychotherapists and so on) will be trained in the PCBH model during 3 days. The psychosocial resources are required to already be equipped with basic training in psychotherapy, for example in CBT or psychodynamic therapies. All training will be followed up with six 4-hour group supervision sessions. PCC leaders, doctors and nurses will be included in the supervision when a need to work on inter-professional issues arises and might also receive some separate, extra supervision for up till 10 h in total if necessary. In addition to this, all PCCs will go through a half-day training of all clinical personnel at the PCC, of which 2 hours is set aside with an implementation group where all professions at the PCC are represented.

The overall main research question is:

1. Is PCBH superior to traditional primary health care in yielding the best patient outcomes regarding level of functioning (primary outcome) and symptoms, reaching the most patients, and reducing wait-times and costs?

Secondary research questions include:

2. Is (1) true also for the sub-group of complex patients with somatic/mental comorbidities and social difficulties?

3. Is PCBH superior to traditional primary care in reducing objectively measured sick-leave? Is this, and level of functioning and symptoms, moderated by which intervention is given within PCBH? Is this true also for the sub-group of complex patients? Is this subgroup also reached by behavioral health interventions more than in traditional primary care?

4. Does the implementation of PCBH result in lower levels of prescribed pharmacological treatment for depression, anxiety, sleep, and pain?

5. What changes to group and organizational variables like teamwork, knowledge about and respect for other professions, clinical knowledge about behavior health and work environment satisfaction occur after the implementation of PCBH?

6. How does the level of fidelity, acceptability and implementation quality affect patient and implementation outcomes? Do these variables moderate results in all above research questions?

7. Which obstacles and facilitators are observed during implementation of PCBH? What factors influence fidelity and health care personnel satisfaction with PCBH?

PCBH has the potential to increase the quality and access of care for many patients with mental and behavioural health problems. This study is the first to step towards answering whether or not the effects of PCBH are large enough to merit large-scale implementation.

Conditions

Psychological Distress; Life Style Induced Illness; Life Stress; Mental Health Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Implementing PCBH directly

PCCs randomized to this arm will immediately start the implementation of PCBH.

Group Type: EXPERIMENTAL

Brief Interventions (BI)

Intervention Type: BEHAVIORAL

'Brief Interventions' (BI) is a multitude of interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI), however interventions from other schools of therapy can also be used. The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.

Delayed implementation of PCBH

PCCs randomized to this arm will have a delayed start of their PCBH implementation, waiting between 5-9 months. During this time, the same patient-level and organizational-level data will be collected from these centers while they continue to use traditional primary care / Care As Usual (CAU) .

Group Type: ACTIVE_COMPARATOR

Care As Usual (CAU)

Intervention Type: BEHAVIORAL

Care As Usual includes the PCC's current routine care for patients with mental and behavioral problems. This can include a multitude of procedures and treatment, such as pharmacological treatment, supportive care, cognitive behavioural therapy (CBT) and psychodynamic therapy of varying lengths. Interviews with patients as well as medical journals will be used to categorise what type of care each individual patient has received.

Interventions

Brief Interventions (BI)

'Brief Interventions' (BI) is a multitude of interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI), however interventions from other schools of therapy can also be used. The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.

Intervention Type: BEHAVIORAL

Care As Usual (CAU)

Care As Usual includes the PCC's current routine care for patients with mental and behavioral problems. This can include a multitude of procedures and treatment, such as pharmacological treatment, supportive care, cognitive behavioural therapy (CBT) and psychodynamic therapy of varying lengths. Interviews with patients as well as medical journals will be used to categorise what type of care each individual patient has received.

Intervention Type: BEHAVIORAL

Other Intervention Names

Focused CBT; Focused ACT; Focused Cognitive Behavioural Therapy; Focused Acceptance and Commitment Therapy

Eligibility Criteria

Inclusion Criteria

• All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.

Exclusion Criteria

• Does not speak Swedish well enough to fill out questionnaires.
• Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

The Kamprad Family Foundation for Entrepreneurship, Research & Charity

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Capio Group

OTHER

Sponsor Role: collaborator

Linnaeus University

OTHER

Sponsor Role: lead

Responsible Party

Viktor Kaldo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Kaldo, Professor

Role: PRINCIPAL_INVESTIGATOR

Linnaeus University, Karolinska Institutet

Locations

Närhälsan Hjällbo Vårdcentral

Angered, , Sweden

Närhälsan Bollebygd Vårdcentral

Bollebygd, , Sweden

Närhälsan Dalsjöfors Vårdcentral

Dalsjöfors, , Sweden

Närhälsan Mösseberg Vårdcentral

Falköping, , Sweden

Närhälsan Oden Vårdcentral

Falköping, , Sweden

Närhälsan Eriksberg Vårdcentral

Gothenburg, , Sweden

Närhälsan Gibraltargatan Vårdcentral

Gothenburg, , Sweden

Närhälsan Majorna Vårdcentral

Gothenburg, , Sweden

Närhälsan Sannegården Vårdcentral

Gothenburg, , Sweden

Närhälsan Gråbo Vårdcentral

Gråbo, , Sweden

Närhälsan Tjörn Vårdcentral

Kållekärr, , Sweden

Närhälsan Solgärde Vårdcentral

Kungälv, , Sweden

Närhälsan Ågårdsskogen Vårdcentral

Lidköping, , Sweden

Närhälsan Mellerud Vårdcentral

Mellerud, , Sweden

Närhälsan Munkedal Vårdcentral

Munkedal, , Sweden

Närhälsan Stenungsund Vårdcentral

Stenungsund, , Sweden

Närhälsan Källstorp Vårdcentral

Trollhättan, , Sweden

Countries

Sweden

References

Farnsworth von Cederwald A, Lilja JL, Hentati Isacsson N, Kaldo V. Primary Care Behavioral Health in Sweden - a protocol of a cluster randomized trial evaluating outcomes related to implementation, organization, and patients (KAIROS). BMC Health Serv Res. 2023 Oct 31;23(1):1188. doi: 10.1186/s12913-023-10180-9.

Reference Type: DERIVED

PMID: 37907899 (View on PubMed)

Other Identifiers

2020-04198-A1

Identifier Type: -

Identifier Source: org_study_id