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

Study acronym: KAIROS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Site details revised at 2 of 4 sitesv5
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v4
  3. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2021 to Jun 14, 2021
    • Site details revised at 4 of 4 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Linnaeus University
17 trials monitored
See 1 trial at risk
Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
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.
Trial Details
NCT Number NCT04900064
Lead Sponsor Linnaeus University
Collaborators: The Kamprad Family Foundation for Entrepreneurship, Research & Charity, Capio Group, Karolinska Institutet
Conditions
(from sponsor)		 Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis, Insomnia, Generalized Anxiety Disorder, Burnout, Adjustment Disorders +5 more
Related terms Adjustment Disorders, Burnout, Psychological, Depression, Generalized Anxiety Disorder, Hypochondriasis, Obsessive-Compulsive Disorder, Panic Disorder, Phobia, Social, Sleep Initiation and Maintenance Disorders, Stress, Psychological
Enrollment 1,242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov