NCT05335382 (KAIROS) is a NA clinical trial of Brief Interventions (BI) in Psychological Distress, sponsored by Linnaeus University.

Who is sponsoring NCT05335382?

NCT05335382 is sponsored by Linnaeus University.

What drugs are being tested in NCT05335382?

Interventions in NCT05335382: Brief Interventions (BI), Care As Usual (CAU).

What condition does NCT05335382 study?

NCT05335382 studies Psychological Distress, Life Style Induced Illness, Life Stress, Mental Health Disorder.

Is NCT05335382 still recruiting?

NCT05335382 is currently active, enrolled. Last updated 13 April 2025.

Last reviewed 2025-04-13 · How we verify

NCT05335382: KAIROS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Implementation and Evaluation of Primary Care Behavioral Health in Sweden

Active, enrolled NA Last updated 13 April 2025

What this trial tests

NA trial testing Brief Interventions (BI) in Psychological Distress in 666 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2022

Primary endpoint
4 April 2024

30 June 2026

Quick facts

Lead sponsor	Linnaeus University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	666
Start date	1 January 2022
Primary completion	4 April 2024
Estimated completion	30 June 2026
Sites	17 locations across Sweden

Drugs / interventions tested

Brief Interventions (BI)
Care As Usual (CAU)

Conditions studied

Psychological Distress — all drugs for Psychological Distress →
Life Style Induced Illness — all drugs for Life Style Induced Illness →
Life Stress — all drugs for Life Stress →
Mental Health Disorder — all drugs for Mental Health Disorder →

Sponsor

Linnaeus University

Who can join

18 and older, any sex, with Psychological Distress or Life Style Induced Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Primary Care Behavioral Health in Sweden - a protocol of a cluster randomized trial evaluating outcomes related to implementation, organization, and patients (KAIROS).
Farnsworth von Cederwald A, Lilja JL, Hentati Isacsson N, Kaldo V. · · 2023 · PMID 37907899 · DOI 10.1186/s12913-023-10180-9
Primary Care Behavioral Health in Sweden – A Cluster Randomized Trial Evaluating Outcomes Related to Implementation, Organization, and Patients (KAIROS) – Study Protocol
von Cederwald AF, Lilja JL, Isacsson NH, Kaldo V. · · 2023 · DOI 10.21203/rs.3.rs-3275738/v1

Verify or expand the search:

Other recruiting trials for Psychological Distress

Currently open trials in the same condition.

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NCT07214428 — Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students · NA · active not recruiting

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05335382 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Linnaeus University
Last refreshed: 13 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05335382.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing