Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03301922 |
| Other study ID # |
2015/1794 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2017 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Norwegian University of Science and Technology |
| Contact |
Odin Hjemdal, prof |
| Phone |
0047 73597889 |
| Email |
odin.hjemdal[@]ntnu.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
