Clinical trial NCT03301922: Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders
Official title: Metacognitive Therapy and Work Interventions for Patients on Sick Leave Due to Common Mental Disorders: A Randomized Waiting List Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Keywords: Occupational Health Services
Metacognitive therapy
Work focused interventions
Sick leave
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Diakonhjemmet Hospital
First posted: 2017-10-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Detailed description: Common mental health disorders (CMD) such as anxiety and depression are leading contributors to the global burden of disease , generating substantial costs for societies in reduced productivity and increased benefit pay outs. In 2010, the worldwide cost of mental health disability was estimated at US$2.5-8.5 trillion in lost output, and the sum is projected to double by 2030 unless effective policy measures are implemented. For middle- and high-income countries, 30-50 % of disability applications stem from mental health issues, and the proportion is likely greater among the younger part of the work force. In Europe, depression is responsible for 13.7 % of all years lived with disability, and anxiety disorders likely have similar impact. Mental health issues are among the leading causes of disability and early retirement across the European region.

For affected individuals, anxiety and depression reduces quality of life, decreases functioning and increases the risk of further health problems. Sick leave is often used for adults with CMD, but may not always be helpful. Avoidance and isolation are behavioural strategies that maintain anxiety and depression. Absenteeism from work, an important social arena, may strengthen this behaviour, impeding recovery. Even when controlling for the impact of ill health, short term sick leave may in itself increase the risk of future long term absence. In addition, employment rates are 10-15% lower for people with mental ill health than the rest of the population. Exclusion from the work force is in turn associated with poorer mental health, and can heighten the risk of futures depression and even suicide. The relationship between CMD and reduced work-participation is therefore likely bidirectional, and sick leave may not work as intended despite its high cost for society.

The individual and societal burden from sick leave and mental health represents a key policy challenge on the global agenda and the need for efficient measures is urgent. Norway exemplifies this urgent need as expenditure on disability and sickness absence totals 5 % of GDP, by far the highest in the OECD. Efforts have been made to address the issue through several policy initiatives, such as the nationwide Faster Return to Work (FRW) program. The program facilitates buying treatment from different actors to reduce waiting times and thus potentially the duration of sick leave. The impact of the program is uncertain, as little research has been done on its efficacy. Scientific data on Norwegian sick leave follow up is mostly absent. Despite the magnitude of the challenge, there is a clear knowledge gap.

Investment in sick leave follow up has not been equally distributed amongst patient groups. Sixty per cent of all working days lost to disability or sick leave are due to mental health issues and musculoskeletal complaints. Sick leave due to CMD is growing. When caused by mental health issues, disability pension is awarded on average nine years earlier than for somatic reasons, resulting in more working years lost to disability. Though prevalent in the statistics, few CMD patients on sick leave receive treatment. Only 1.4 % of employees on sick leave are referred to specialized mental health treatment. As many as one in three people awarded disability pension for mental illness have never received any form of treatment prior to disability being granted. This shows a severe under-referral and under-treatment for this patient group despite being responsible for the majority of sick leave and disability costs.

A more targeted approach, integrating work-focused interventions with effective CMD treatment is needed for this patient group. Two recent studies have examined such an approach. In the Netherlands, Lagerveld and Blonk conducted a randomized controlled trial where 168 patients on sick leave due to CMD received either cognitive behavioural therapy (CBT), or CBT with an integrated work-focused intervention. Their results showed a 20 % decrease in sickness absence for patients receiving the work-focused intervention, while maintaining effective symptom reduction. In Germany, similar results were found with a smaller sample size. A multicentre trial in Norway looked at registry data for 1193 CMD patients receiving a variation of work-specific interventions, showing a clear reduction in sick leave and disability. Integrated work-focused treatment for CMD is thus a promising avenue of research.

Metacognitive therapy (MCT) is a treatment based on more recent theoretical developments. It has shown excellent results for anxiety and depression, and the treatment protocol for generalized anxiety disorder and social phobia is recommended in the NICE guidelines. Rather than challenging and changing specific thought content (CBT), metacognitive treatment aims to change and challenge maladaptive cognitive processes, among these rumination and worry, which are key components in CMD and sick leave.

The study will be a randomized controlled trial. Participants will be persons with a primary diagnosis of common mental disorders, anxiety and depression. Experienced independent diagnosticians will assess all patients by using structural interviews MINI (MINI International Neuropsychiatric Interview).

All patients will be randomized in blocks to two groups in order to compare the following conditions: MCT and work-focused interventions, and a wait list control condition. After the waiting period of either 8 or 12 weeks, the patients in the wait-list condition will be allocated to the treatment condition. Both between-subjects and within-subjects comparisons will be conducted.

Questions that will be addressed are:

1. MCT and work-focused interventions will be superior to the wait-list condition in make participants return to work
2. Which changes in predictors related to treatment predict return to work
3. MCT and work-focused interventions will be superior to the wait-list condition for improving mental health
4. MCT and work-focused interventions will be more cost-efficient than the wait-list condition
5. Evaluate the sustainability of return to work for patients on sick leave due to common mental disorders after MCT and work-focused interventions
6. Examine impact of different potential prognostic factors on work function, both at the end of treatment and at one year follow-up.
7. If the effect of MCT and work-focused interventions will sustain one year after the end of therapy
8. Explore if patients will have reduced use of sick leave in the four years following after treatment compared to the two years prior to treatment based on register data.

The meta-cognitive treatment program is based on Wells' manual. The work-focused intervention is based on an adopted Norwegian version of Lagerveld and Blonk. The interventions are run in parallel. The patients who are receiving MCT and work-focused interventions will be treated up to maximum 12 sessions, with weekly session of 45-60 minute duration.

The treatment will be administered according to the originators published treatment protocols for MCT.

1. All patients referred to the clinic will be consecutively assessed at intake (MINI). Based on diagnosis and criteria for inclusion and exclusion, the patients will be asked to volunteer to participate in the study and confirm by signing a form of consent.
2. Patients will be randomized to one of the two conditions.
3. Patients will be asked to self-rate symptoms on a battery of self-report questionnaires.
4. Work-focused meta-cognitive therapy will be given to patients in group 1, while group 2 is a waiting list control. Waiting list controls will be rated but not treated and will wait for treatment for either 8 or 12 weeks.
5. After waiting they will be transferred to the treatment group.
6. The patients will be assessed prior to treatment, by at end of treatment weeks in treatment, and at six months and at, one and two years of follow-up.
7. Reassessment of the diagnosis and symptom severity is made by post-treatment.

Criteria for recovery will be: Jacobsen criteria of a minimum change and patients crossing the cut-off point on two measures: The BDI and BAI. Other outcome measures will include:

* Reduction of depressive symptoms as measured by self-report questionnaires
* Number of patients with no diagnosis based on MINI after treatment
* Relapse rate during six months and at, one year follow-up

A comparison between the two groups of patients will be conducted at post-treatment. Follow-up data will be analysed based on 6 month and at one year of follow up for the treatment condition with self-report and a four year follow-up with register data. A within group analyses will be conducted in order to estimate effect sizes and significant clinical change estimates.

Participants will be randomized in patients divided on three conditions in a 1:2 ratio. One factors are controlled for in the randomization, namely, gender. A computer program provided by NTNU WebCRF will generate the randomization list.

Eligibility 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

Primary outcomes:
measure: Changes in degree of sick leave
timeFrame: From 2 years prior to intervention - to 4 years after intervention
measure: Changes in degree of sick leave
timeFrame: From 2 years prior to intervention - to 4 years after intervention
measure: Changes in anxiety symptoms
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in depressive symptoms
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months 1 year follow-up
Secondary outcomes:
measure: Changes in metacognitions
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in subjective health complaints
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in bullying and victimisation at work
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in self-efficacy
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in resilience
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: Changes in quality of life
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
measure: MINI - diagnostic interview
timeFrame: From pre treatment, to post treatment (12 weeks)
Other outcomes:
measure: Secondary analysis related to the onset of Covid-19
timeFrame: From pre treatment, to post treatment (12 weeks), 6 months and 1 year follow-up
Locations:
city: Oslo
country: Norway
facility: Poliklinikken Raskere Tilbake, Diakonhjemmet Sykehus
Study officials:
affiliation: Norwegian University of Science and Technology
name: Odin Hjemdal, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Diakonhjemmet Hospital
name: Ragne GH Gjengedal
role: STUDY_CHAIR
References:
citation: Sandin 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.