Implementation and Evaluation of Primary Care Behavioral Health in Sweden

NCT05335382 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2025-04-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV
  • The Kamprad Family Foundation for Entrepreneurship, Research & Charity

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • Capio Group

    collaborator OTHER
  • Linnaeus University

    lead OTHER

Principal Investigators

  • Viktor Kaldo, Professor · Linnaeus University, Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-04-04
Completion
2026-06-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335382 on ClinicalTrials.gov