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A Multicentre Randomised Controlled Trial of the Norwegian Health in Work Service. The NSAC Efficacy Study

Study acronym: NSAC
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Sep 2026 to Oct 2026
    • Study title expanded, about 3 words
    v11
  2. Eligibility criteria expanded, about 13 words
    • Collaborators: 5 to 4
    v10
  3. Eligibility criteria expanded, about 24 wordsv9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v8
  5. Primary completion date: Oct 2024 to Sep 2026
    • Secondary endpoints: details revised at 15 of 15 entries
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria expanded, about 23 wordsv6
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jan 2023 to Jan 16, 2023
    v4
  4. Primary completion date: Feb 2024 to Oct 2024v3 Show 5 more changesShow less
    • Study completion date: Feb 2030 to Oct 2034
    • Start date: Dec 2022 to Jan 2023
    • Interventions: NSAC - ordinary (Other), NSAC - rapid (Other), NSAC - waiting list control (Other) to NSAC - active control (Other), NSAC - ordinary (Other), NSAC - rapid (Other)
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 667 words
  5. Start date: May 2022 to Dec 2022
    • Primary completion date: Sep 2023 to Feb 2024
    • Study completion date: Sep 2029 to Feb 2030
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Nordlandssykehuset HF
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Anxiety
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Depression
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The Norwegian Sickness Absence Clinic (NSAC) is a publicly funded specialist outpatient health service, which is uniquely available for the work force. The overall aim of the NSAC is prevention of sickness absence, promote return to work (RTW) among those on sickness absence and prevent long term disability benefit dependency. In addition to being a health service, the NSAC has a focus on work and functional recovery, including also non-health related factors. Patients can be referred by general practitioners for mental health problems and musculoskeletal problems. The NSAC has a lower threshold for severity than specialist health services generally, and in particular for mental health problems. The efficacy of this service is unknown. The NSAC Efficacy Study is a randomized controlled multicentre trial which aims to assess the effect of the NSAC service. "Helse i Arbeid" is the Norwegian name for NSAC, and the Norwegian abbreviation is "HiA". The Norwegian study name is HIANOR. The NSAC Efficacy Study involves five different NSACs across northern Norway, and will recruit 2500 patients, randomized to in equal proportions to three treatment arms: 1. NSAC - rapid: treatment at the NSAC at- or within 4 weeks 2. NSAC - ordinary: treatment at the NSAC after 10-14 weeks 3. NSAC - active control: monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval) The overall aim is to assess the effect of the NSAC service, with the hypothesis that the NSAC service is superior to what resembles treatment as usual (TAU) for outcomes such as return to work or improved health (waiting list control). Many of the diagnoses or problems for which patients are referred to the NSACs naturally improve regardless of health interventions, and - as of date - no research has been conducted to assess the efficacy of the service.
Trial Details
NCT Number NCT05310695
Lead Sponsor Nordlandssykehuset HF
Collaborators: University Hospital of North Norway, Helgeland Hospital Trust, Finnmarkssykehuset HF (Kirkenes, Norway), UiT The Arctic University of Norway
Conditions
(from sponsor)		 Musculoskeletal Disorder, Anxiety Disorders, Depression, Fatigue, Pain, Occupational Exposure, Work Related Stress, Workplace Bullying +3 more
Related terms Anxiety Disorders, Bullying, Depression, Fatigue, Musculoskeletal Diseases, Occupational Stress, Pain
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov