Mental DisordersNCT01181635
Can Psychotherapy Reduce Sickness Absence?
A study testing Psychotherapy in people with Mental Disorders, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to examine if psychotherapy can reduce sickness absence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine if psychotherapy can reduce sickness absence.
Read the detailed description
Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.
- Conditions
- Mental Disorders
- Being tested
- Psychotherapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Standard psychotherapy for psychiatric disorders.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Short-term pychotherapy and/or psychoeduchative courses. Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence
Present status (working or sick).
Measured: Before, after and 6 months after treatment.
Secondary outcomes (2)
Psychiatric symptoms
CORE-OM.
Measured: Before, after and 6 months after treatment.
Quality of life (QALY)
15 D
Measured: Before, after and 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
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 Mental DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bjørn Lau, phd, Study director, Lovisenberg Diakonale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181635
- Sponsor's protocol ID
- 2010/494 (REK)
- Status last verified
- Apr 2016
- First submitted
- 12 Aug 2010
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Victor M, Lau B, Ruud T. Predictors of Return to Work 6 Months After the End of Treatment in Patients with Common Mental Disorders: A Cohort Study. J Occup Rehabil. 2018 Sep;28(3):548-558. doi: 10.1007/s10926-017-9747-5.
PubMed 29234955Victor M, Lau B, Ruud T. Predictors of return to work among patients in treatment for common mental disorders: a pre-post study. BMC Public Health. 2017 Jul 18;18(1):27. doi: 10.1186/s12889-017-4581-4.
PubMed 28720129
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Psychotherapy Reduce Sickness Absence?
- ClinicalTrials.gov ID
- NCT01181635
- Acronym / sponsor ID
- 2010/494 (REK)
- Conditions
- Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Aug 2010 (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 purpose of this study is to examine if psychotherapy can reduce sickness absence.
Detailed description
Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: PsychotherapyShort-term pychotherapy and/or psychoeduchative courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PsychotherapyStandard psychotherapy for psychiatric disorders. | Behavioural | Psychotherapy |
Primary outcome
Sickness absence
Time frame: Before, after and 6 months after treatment.
Present status (working or sick).
2 secondary outcomes
Psychiatric symptoms
Time frame: Before, after and 6 months after treatment.
Quality of life (QALY)
Time frame: Before, after and 6 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 29234955Victor M, Lau B, Ruud T. Predictors of Return to Work 6 Months After the End of Treatment in Patients with Common Mental Disorders: A Cohort Study. J Occup Rehabil. 2018 Sep;28(3):548-558. doi: 10.1007/s10926-017-9747-5.
- Derived from this study: PubMed 28720129Victor M, Lau B, Ruud T. Predictors of return to work among patients in treatment for common mental disorders: a pre-post study. BMC Public Health. 2017 Jul 18;18(1):27. doi: 10.1186/s12889-017-4581-4.
- Individual participant dataSharing planned: No
Related trials for Mental Disorders
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
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.
Bjørn Lau, phd study director
Lovisenberg Diakonale Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Mental Disorders, run by Lovisenberg Diakonale Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. 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?
Results are not available in the source record.
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?
Sickness absence (time frame: Before, after and 6 months after treatment.). 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 NCT01181635, 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 9 Aug 2019.