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Work-focused Metacognitive Therapy for Patients on Sick Leave Due to Common Mental Disorders

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ClinicalTrials.gov Identifier: NCT03301922
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Common mental health disorders such as anxiety and depression are leading causes of sickness absence and disability in Norway. Despite tremendous costs for individual and society, effective treatment is lacking. Mental health interventions do not typically target work situation, despite its importance for patient well-being. On a policy level, effective measures are impeded by a paucity of scientific data, and programs designed to address the issue such as Faster Return to Work ("Raskere tilbake") lack evaluation. The present project will test the effectiveness of integrated work-focused metacognitive therapy for reducing sick leave in patients with common mental disorders.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Work-focused Metacognitive therapy Other: Waiting list Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Work-focused Metacognitive Therapy for Patients on Sick Leave Due to Common Mental Disorders: A Randomized Waiting List Controlled Trial
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Work-focused metacognitive therapy
Work-focused metacognitive therapy
Behavioral: Work-focused Metacognitive therapy
Work-focused Metacognitive psychotherapy, up to maximum 12 sessions, with weekly session of 45-60 minute duration. The metacognitive treatment program is based on Wells' manual. The work-focused intervention is based on Lagerveld and Blonk. The interventions are run in parallel.

Waiting list
Waiting list
Behavioral: Work-focused Metacognitive therapy
Work-focused Metacognitive psychotherapy, up to maximum 12 sessions, with weekly session of 45-60 minute duration. The metacognitive treatment program is based on Wells' manual. The work-focused intervention is based on Lagerveld and Blonk. The interventions are run in parallel.

Other: Waiting list
Waiting list




Primary Outcome Measures :
  1. Changes in degree of sick leave [ Time Frame: From 2 years prior to intervention to 4 years after intervention ]
    data from National registers


Secondary Outcome Measures :
  1. Changes in depressive symptoms [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)

  2. Changes in anxiety symptoms [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes in anxiety symptoms measured by Beck Anxiety Inventory (BAI)

  3. Changes in metacognitions [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes in metacognitions symptoms measured by the Metacognitions Questionnaire 30 (MCQ-30)

  4. Changes in subjective health complaints [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes in symptoms measured by Subjective Health Complaints

  5. Changes in bullying and victimisation at work [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes in measured Negative Acts Questionnaire

  6. Changes in self-efficacy [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes measured with Return to work self-efficacy

  7. Changes in resilience [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes measured with The resilience scale for adults (RSA)

  8. Changes in quality of life [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 and 2 years follow-up ]
    Changes measured with EQ-5D-5L

  9. MINI - diagnostic interview [ Time Frame: From pre treatment, to post treatment (12 weeks) ]
    Diagnostic evaluations using MINI - International Neuropsychiatric Interview



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • on sick leave either partial or full, due to
  • clinically relevant level of anxiety and depression, and
  • eligible for work-related sick leave pay outs
  • given consent

Exclusion Criteria:

  • Serious mental illness (such as bipolar disorder or schizophrenia)
  • Substance abuse
  • Cluster A and B personality disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301922


Contacts
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Contact: Odin Hjemdal, prof 0047 73597889 odin.hjemdal@ntnu.no

Locations
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Norway
Poliklinikken Raskere Tilbake, Diakonhjemmet Sykehus Recruiting
Oslo, Norway
Contact: Odin Hjemdal, phd prof       odin.hjemdal@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Diakonhjemmet Hospital
Investigators
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Principal Investigator: Odin Hjemdal, prof Norwegian University of Science and Technology
Study Chair: Ragne GH Gjengedal Diakonhjemmet Hospital

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03301922     History of Changes
Other Study ID Numbers: 2015/1794
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Occupational Health Services
Metacognitive therapy
Work focused therapy
Sick leave

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders