Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders
1 other identifier
interventional
240
1 country
1
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 Metacognitive therapy and work-focused interventions for reducing sick leave in patients with common mental disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Oct 2017
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedSeptember 19, 2022
September 1, 2022
5.4 years
September 29, 2017
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in degree of sick leave
data from National registers
From 2 years prior to intervention - to 4 years after intervention
Changes in degree of sick leave
data from patients self-report
From 2 years prior to intervention - to 4 years after intervention
Changes in anxiety symptoms
Changes in depressive symptoms measured by Beck Anxiety Inventory (BAI)
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Changes in depressive symptoms
Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)
From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up
Secondary Outcomes (7)
Changes in metacognitions
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Changes in subjective health complaints
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Changes in bullying and victimisation at work
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Changes in self-efficacy
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Changes in resilience
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
- +2 more secondary outcomes
Other Outcomes (1)
Secondary analysis related to the onset of Covid-19
From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Study Arms (2)
Work-focused metacognitive therapy
EXPERIMENTALWork-focused metacognitive therapy
Waiting list
OTHERWaiting list
Interventions
Metacognitive therapy and work-focused interventions, 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Serious mental illness (such as bipolar disorder or schizophrenia)
- Substance abuse
- Cluster A and B personality disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poliklinikken Raskere Tilbake, Diakonhjemmet Sykehus
Oslo, Norway
Related Publications (2)
Gjengedal RGH, Hannisdal M, Osnes K, Reme SE, Wells A, Blonk R, Lending HD, Johnson SU, Lagerveld SE, Anyan F, Nordahl HM, Gerritsen RBTW, Bjorndal MT, Wright D, Sandin K, Bjontegard KS, Schwach J, Hjemdal O. Metacognitive therapy and work-focus for patients with depression, anxiety or comorbid depression and anxiety on sick leave: a single-centre, open-label randomised controlled trial. EClinicalMedicine. 2025 Nov 6;89:103613. doi: 10.1016/j.eclinm.2025.103613. eCollection 2025 Nov.
PMID: 41357335DERIVEDSandin K, Gjengedal RGH, Osnes K, Hannisdal M, Berge T, Leversen JSR, Rov LG, Reme SE, Lagerveld S, Blonk R, Nordahl HM, Shields G, Wells A, Hjemdal O. Metacognitive therapy and work-focused interventions for patients on sick leave due to anxiety and depression: study protocol for a randomised controlled wait-list trial. Trials. 2021 Nov 27;22(1):854. doi: 10.1186/s13063-021-05822-4.
PMID: 34838125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odin Hjemdal, prof
Norwegian University of Science and Technology
- STUDY CHAIR
Ragne GH Gjengedal
Diakonhjemmet Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2017
First Posted
October 4, 2017
Study Start
October 31, 2017
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
September 19, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share