Implementation and Evaluation of Primary Care Behavioral Health in Sweden

NCT05335382 | Active Not Recruiting

• 1 other identifier: 2020-04198-A1
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)

  The eight items constituting the four domains of Life activities, Cognition, Getting along, and Participation in the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.

  Change during the period Pre, Week 4, Week 8, and Week 12

• Waiting time until first appointment

  Waiting time from the patient contacting their PCC with a behavioural health concern to being seen by a physician or psychosocial resource among patients in the study

  From documented identification/self-referral to documented first visit at PCC (up to 6 months after identification)

Secondary Outcomes (27)

• WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (2 domains)

  Change during the period Pre, Week 12 and 1 year

• Third next available appointment (TNAA)

  Measured each week from implementation to up to 2 years

• Patient Health Questionnaire 9-Item (PHQ-9)

  Change during the period Pre, Week 12 and 1 year

• Patient Health Questionnaire 2-Item (PHQ-2)

  Change during the period Pre, Week 4, Week 8, Week 12 and 1 year

• Generalized Anxiety Disorder 7-item (GAD-7)

  Change during the period Pre, Week 12 and 1 year

Other Outcomes (21)

• Change during the period Pre, Week 12 and 1 year

  Pre, Week 12, 1 year

• Availability of bookable appointments

  Monthly from study start up to 2 years

• Future capacity

  Monthly from study start up to 2 years

Study Arms (2)

Implementing PCBH directly

EXPERIMENTAL

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

Behavioral: Brief Interventions (BI)

Delayed implementation of PCBH

ACTIVE COMPARATOR

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) .

Behavioral: Care As Usual (CAU)

Interventions

Brief Interventions (BI) 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.

Also known as: Focused CBT, Focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy

Implementing PCBH directly

Care As Usual (CAU) 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.

Delayed implementation of PCBH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linnaeus University: lead
• Vastra Gotaland Region: collaborator
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator
• Karolinska Institutet: collaborator
• Capio Group: collaborator

Study Sites (17)

Närhälsan Hjällbo Vårdcentral

Angered, Sweden

Location

Närhälsan Bollebygd Vårdcentral

Bollebygd, Sweden

Location

Närhälsan Dalsjöfors Vårdcentral

Dalsjöfors, Sweden

Location

Närhälsan Mösseberg Vårdcentral

Falköping, Sweden

Location

Närhälsan Oden Vårdcentral

Falköping, Sweden

Location

Närhälsan Eriksberg Vårdcentral

Gothenburg, Sweden

Location

Närhälsan Gibraltargatan Vårdcentral

Gothenburg, Sweden

Location

Närhälsan Majorna Vårdcentral

Gothenburg, Sweden

Location

Närhälsan Sannegården Vårdcentral

Gothenburg, Sweden

Location

Närhälsan Gråbo Vårdcentral

Gråbo, Sweden

Location

Närhälsan Tjörn Vårdcentral

Kållekärr, Sweden

Location

Närhälsan Solgärde Vårdcentral

Kungälv, Sweden

Location

Närhälsan Ågårdsskogen Vårdcentral

Lidköping, Sweden

Location

Närhälsan Mellerud Vårdcentral

Mellerud, Sweden

Location

Närhälsan Munkedal Vårdcentral

Munkedal, Sweden

Location

Närhälsan Stenungsund Vårdcentral

Stenungsund, Sweden

Location

Närhälsan Källstorp Vårdcentral

Trollhättan, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37907899 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Mental Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Viktor Kaldo, Professor

  Linnaeus University, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will only be informed that the study is assessing the quality of primary care, and will not know that PCBH has been or will be implemented. Since primary and most secondary outcomes are patient-rated, outcomes assessors are also deemed to be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Primary care centers are cluster randomized between implementing PCBH directly or implementing later. Patients seeking care at each PCC are not individually randomized, but are given the form of care that is currently offered at their PCC (pre- or post-implementation).

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: April 19, 2022
• Study Start: January 1, 2022
• Primary Completion: April 4, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (17)