Complex Symptom DisordersNCT01568970
Multidisciplinary Return-to-work Rehabilitation and Return-to Work Follow-up
A study testing Return-to-work Rehabilitation + Follow up and Return-to-work rehabilitation in people with Complex Symptom Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Complex Symptom Disorders
- What is being tested?
- Return-to-work Rehabilitation + Follow up and Return-to-work rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-59 years
- A self defined goal of increasing their work ability and work participation within a period of no more than six months
- They fill the criteria of a complex symptom disorder, or they are diagnosed with a common mental disorder
- A satisfactory level of examination and treatment to participate at Hysnes Rehabilitation Centre
- Sick leave > 8weeks or receiving work ability assessment benefit for any diagnosis, except as stated below.
- On a level of linguistic, physical and mental function required to participate in the rehabilitation
Who cannot join
- Ongoing alcohol/drug abuse
- Ongoing psychosis, ongoing manic episode or suicide risk
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large cost for the Norwegian society.
The purpose of this study is to determine whether the patients included return to work after rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is considered to be the effect of Return-to-work rehabilitation measured before, during and after the stay at the rehabilitation centre:
Read more
The study specifically looks at the effect of structured and standardized return-to-work follow up of the patient, including contact with stakeholders (general practitioner, social security office and workplace).
In addition there is a need to describe the patients participating in the program. The aetiology of complex symptom disorders is poorly understood and the role of genetics and stress is not translatable to a complex symptom population. This complicates the transition from current biological research to a clinical use regarding these patients. If the investigators can assist in understanding how these patients, who are multiusers of health care and have received sickness benefit for a long time, develop their disorders and symptoms, it will be of great importance to the Norwegian community. Therefore the study consists of multimodal measurements of the patients before, during and after a rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol, medical-, psychological-, physiological diagnostics and work related factors.
Related aims:
Investigate if multidisciplinary treatment based on acceptance and commitment therapy, contributes to normalisation of cortisol release with regards to a standardized stress test.
See wether individual differences regarding the stress profile can predict return to work in patients with complex symptom disorders.
Investigate genetic risk factors in relation to Return to Work rehabilitation and identify treatment moderators in a multidisciplinary rehabilitation program.
- Conditions
- Complex Symptom Disorders
- Being tested
- Return-to-work Rehabilitation + Follow up, Return-to-work rehabilitation
- Keywords
- rehabilitation, return to work, sick leave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return-to-work Rehabilitation + Follow upBehavioural
Also called Acceptance commitment therapy
3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up
Return-to-work rehabilitationBehavioural
Also called Acceptance commitment therapy
3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up
| Study group | Role | What they receive |
|---|---|---|
| Return to work follow-up | Experimental | Regular contact between the patient and his/her caretaker at the rehabilitation center over a 6 month period, including joint communication between patient, caretaker at the rehabilitation center and stake holders such as social security office, general practitioner and workplace. Receives: Behavioral: Return-to-work Rehabilitation + Follow up |
| Standard follow-up | Active comparator | Standard follow-up of the patient after ended rehabilitation by the return-to-work stakeholders, ie. the general practitioner, social security office and the employer. Limited contact between the caretaker at the rehabilitation center and the patient and stakeholders. Receives: Behavioral: Return-to-work rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Differences in cumulative days of sick leave, as reported by the government database "FD-Trygd".
Measured: 1 year after the end of the stay at the rehabilitation center.
Secondary outcomes (3)
quality of life
Quality of life is assessed by 15D, SF8 and function subscale in SF-36
Measured: 5 years after the end of the rehabilitation stay
Functional status
Functional status will be measured with elements from the Norwegian Function Assessment Scale (Osteras et al., 2007) and the function subscale of SF-36 (Ware Jr \& Sherbourne, 1992)
Measured: 5 year after the end of the rehabilitation stay
level of symptoms (somatic and psychological)
The Hospital Anxiety and Depression Scale (HADS) measure changes in anxiety and depression.
Changes regarding physical and mental fatigue are registered through the Chalder Fatigue Questionnaire.
Changes in participants subjective experience of pain measured by numerical rating scale (NRS)
Measured: 5 year after the end of the rehabilitation stay,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Symptom DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petter Borchgrevink, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568970
- Sponsor's protocol ID
- 2010/2404
- Status last verified
- Dec 2018
- First submitted
- 8 Mar 2012
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hara KW, Bjorngaard JH, Brage S, Borchgrevink PC, Halsteinli V, Stiles TC, Johnsen R, Woodhouse A. Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation. J Occup Rehabil. 2018 Jun;28(2):265-278. doi: 10.1007/s10926-017-9711-4.
PubMed 28597308Vethe D, Kallestad H, Jacobsen HB, Landro NI, Borchgrevink PC, Stiles TC. The Relationship Between Improvement in Insomnia Severity and Long-Term Outcomes in the Treatment of Chronic Fatigue. Front Psychol. 2018 Sep 21;9:1764. doi: 10.3389/fpsyg.2018.01764. eCollection 2018.
PubMed 30298037
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
- ClinicalTrials.gov ID
- NCT01568970
- Acronym / sponsor ID
- 2010/2404
- Conditions
- Complex Symptom Disorders
- Keywords
- rehabilitation, return to work, sick leave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large cost for the Norwegian society.
The purpose of this study is to determine whether the patients included return to work after rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is considered to be the effect of Return-to-work rehabilitation measured before, during and after the stay at the rehabilitation centre:
The study specifically looks at the effect of structured and standardized return-to-work follow up of the patient, including contact with stakeholders (general practitioner, social security office and workplace).
In addition there is a need to describe the patients participating in the program. The aetiology of complex symptom disorders is poorly understood and the role of genetics and stress is not translatable to a complex symptom population. This complicates the transition from current biological research to a clinical use regarding these patients. If the investigators can assist in understanding how these patients, who are multiusers of health care and have received sickness benefit for a long time, develop their disorders and symptoms, it will be of great importance to the Norwegian community. Therefore the study consists of multimodal measurements of the patients before, during and after a rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol, medical-, psychological-, physiological diagnostics and work related factors.
Related aims:
Investigate if multidisciplinary treatment based on acceptance and commitment therapy, contributes to normalisation of cortisol release with regards to a standardized stress test.
See wether individual differences regarding the stress profile can predict return to work in patients with complex symptom disorders.
Investigate genetic risk factors in relation to Return to Work rehabilitation and identify treatment moderators in a multidisciplinary rehabilitation program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Return to work follow-up | Experimental | Behavioral: Return-to-work Rehabilitation + Follow upRegular contact between the patient and his/her caretaker at the rehabilitation center over a 6 month period, including joint communication between patient, caretaker at the rehabilitation center and stake holders such as social security office, general practitioner and workplace. |
| Standard follow-up | Active comparator | Behavioral: Return-to-work rehabilitationStandard follow-up of the patient after ended rehabilitation by the return-to-work stakeholders, ie. the general practitioner, social security office and the employer. Limited contact between the caretaker at the rehabilitation center and the patient and stakeholders. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-59 years
- A self defined goal of increasing their work ability and work participation within a period of no more than six months
- They fill the criteria of a complex symptom disorder, or they are diagnosed with a common mental disorder
- A satisfactory level of examination and treatment to participate at Hysnes Rehabilitation Centre
- Sick leave > 8weeks or receiving work ability assessment benefit for any diagnosis, except as stated below.
Key exclusion criteria (3 listed)
- Ongoing alcohol/drug abuse
- Ongoing psychosis, ongoing manic episode or suicide risk
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Return-to-work Rehabilitation + Follow upAlso: Acceptance commitment therapy3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up | Behavioural | Return to work follow-up |
| Return-to-work rehabilitationAlso: Acceptance commitment therapy3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up | Behavioural | Standard follow-up |
Primary outcome
Return to work
Time frame: 1 year after the end of the stay at the rehabilitation center.
Differences in cumulative days of sick leave, as reported by the government database "FD-Trygd".
3 secondary outcomes
quality of life
Time frame: 5 years after the end of the rehabilitation stay
Functional status
Time frame: 5 year after the end of the rehabilitation stay
level of symptoms (somatic and psychological)
Time frame: 5 year after the end of the rehabilitation stay,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Results publication: PubMed 28597308Hara KW, Bjorngaard JH, Brage S, Borchgrevink PC, Halsteinli V, Stiles TC, Johnsen R, Woodhouse A. Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation. J Occup Rehabil. 2018 Jun;28(2):265-278. doi: 10.1007/s10926-017-9711-4.
- Derived from this study: PubMed 30298037Vethe D, Kallestad H, Jacobsen HB, Landro NI, Borchgrevink PC, Stiles TC. The Relationship Between Improvement in Insomnia Severity and Long-Term Outcomes in the Treatment of Chronic Fatigue. Front Psychol. 2018 Sep 21;9:1764. doi: 10.3389/fpsyg.2018.01764. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Borchgrevink principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return-to-work Rehabilitation + Follow up and Return-to-work rehabilitation in people with Complex Symptom Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: 1 year after the end of the stay at the rehabilitation center.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568970, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.