Clinical Trial

Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial

Study acronym: KAIROS

Recruiting

Record status

This record was last updated April 11, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Summary

In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2021-05-19; most recent amendment 2025-04-08.

Status change: Not Yet Recruiting → Recruiting 2021-07-13

Trial Details

NCT Number	NCT04900064
Lead Sponsor	Linnaeus University Collaborators: The Kamprad Family Foundation for Entrepreneurship, Research & Charity, Capio Group, Karolinska Institutet
Conditions	Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis, Insomnia, Generalized Anxiety Disorder, Burnout, Adjustment Disorders +5 more
Enrollment	1,242 participants
Start Date	2021-06-14
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-11