Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03301922 |
Recruitment Status :
Recruiting
First Posted : October 4, 2017
Last Update Posted : September 2, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anxiety Depression | Behavioral: Metacognitive therapy and work-focused interventions Other: Waiting list | Not Applicable |

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: | Metacognitive Therapy and Work Interventions 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Work-focused metacognitive therapy
Work-focused metacognitive therapy
|
Behavioral: Metacognitive therapy and work-focused 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. |
Waiting list
Waiting list
|
Behavioral: Metacognitive therapy and work-focused 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. Other: Waiting list Waiting list |
- Changes in degree of sick leave [ Time Frame: From 2 years prior to intervention - to 4 years after intervention ]data from National registers
- Changes in degree of sick leave [ Time Frame: From 2 years prior to intervention - to 4 years after intervention ]data from patients self-report
- Changes in anxiety symptoms [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes in depressive symptoms measured by Beck Anxiety Inventory (BAI)
- Changes in depressive symptoms [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up ]Changes in depressive symptoms measured by Beck Depression Inventory II (BDI-II)
- Changes in metacognitions [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes in metacognitions symptoms measured by the Metacognitions Questionnaire 30 (MCQ-30)
- Changes in subjective health complaints [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes in symptoms measured by Subjective Health Complaints
- Changes in bullying and victimisation at work [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes in measured Negative Acts Questionnaire
- Changes in self-efficacy [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes measured with Return to work self-efficacy
- Changes in resilience [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes measured with The resilience scale for adults (RSA)
- Changes in quality of life [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Changes measured with EQ-5D-5L
- MINI - diagnostic interview [ Time Frame: From pre treatment, to post treatment (12 weeks) ]Diagnostic evaluations using MINI - International Neuropsychiatric Interview
- Secondary analysis related to the onset of Covid-19 [ Time Frame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up ]Sub-analyses taking into consideration the onset of Covid-19 in Norway by mid March 2020

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Odin Hjemdal, prof | 0047 73597889 | odin.hjemdal@ntnu.no |
Norway | |
Poliklinikken Raskere Tilbake, Diakonhjemmet Sykehus | Recruiting |
Oslo, Norway | |
Contact: Odin Hjemdal, phd prof odin.hjemdal@ntnu.no |
Principal Investigator: | Odin Hjemdal, prof | Norwegian University of Science and Technology | |
Study Chair: | Ragne GH Gjengedal | Diakonhjemmet Hospital |
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT03301922 |
Other Study ID Numbers: |
2015/1794 |
First Posted: | October 4, 2017 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Occupational Health Services Metacognitive therapy Work focused interventions Sick leave |
Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders |