Stress, PsychologicalNCT01637363
Psychoeducation to Sick-listed Individuals With Mental Health Problems
A study testing Psychoeducation in people with Stress, Psychological, run by University of Aarhus at 1 site in Denmark.
Trial summary
In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Psychoeducation
- 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 siteDenmark
- Study dates
- Sep 2012to Feb 2016
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A score of 5 or more on SCL-8AD
Who cannot join
- Sick listed due to psychiatric symptoms in a period of 3 months or longer in the last year
- pregnant
- has a flexible job
- receive pension
- not communicating in Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Research Unit West, Regional Psychiatric Services
Herning, 7400
About this study
In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms.
The aim of this project is to systematically compare psychoeducation with the various standard offers to sick listed individuals with mental health conditions provided by job centers in four municipalities.
Read more
Psychoeducation is employed within the psychiatric healthcare system and is defined as a group based treatment by means of educating participants about psychiatric conditions. In the present project, the employed psychoeducation focuses on psyche and work life, and its purpose is to impart knowledge about psychiatric conditions in order to provide the sick listed individuals with qualifications to understand, and, thereby, improve their own situation. Among others, there will be information about the symptoms of various psychiatric conditions, diagnoses, and treatment options. Furthermore, the participants will learn about specific, useful, cognitive tools in regards to the barriers and difficulties they might experience when reentering the work force and leave sickness absence behind.
The project is designed as a randomized clinical trial in which the participants are offered either 1) psychoeducation as well as the standard offer to sick listed individuals provided by the municipality in which the individual lives or 2) the participants are offered merely the standard offer to sick listed individuals provided by the municipality.
The target group consists of recently sick listed individuals with mental health issues - whether diagnosed or not. The individuals must be inhabitants of the municipalities of Struer, Lemvig, Skive, and Holstebro.
The outcome measure is the determined as the duration of the sickness absence, the severity of the psychiatric condition, self-reported health, and 'locus of control´. These outcome measurements are assessed at baseline and after 3 and 6 months.
- Conditions
- Stress, Psychological
- Being tested
- Psychoeducation
- Keywords
- Psychoeducation, Stress, Sickness absence, Psychiatric symptoms, Locus of control, Self reported health
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
6 x 2 hours of psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Regular treatment | No intervention | This group is offered regular treatment from the job center i.e. exercise, mindfulness |
| Psychoeducation | Experimental | 6 x 2 hours of psychoeducation Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of sickness absence
Measured: 6 months after randomization
Secondary outcomes (3)
Locus of control
Measured: Baseline, 3 and 6 months after randomization
Self reported health
Measured: Baseline, 3 and 6 months after randomization
Psychological symptoms
Measured: Baseline, 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2016
- Study completionFeb 2016
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 Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Hans Jørgen Søgaard, MD, ph.d., Study chair, Psychiatric Research Unit West, Regional Psychiatric ServicesPernille Pedersen, MHs, Principal investigator, Psychiatric Research Unit West, Regional Psychiatric ServicesEllen A Nøhr, ph.d., Study chair, Institute of Clinical Research, University of Southern DenmarkChris Jensen, ph.d., Study chair, National Advisory Unit for Occupational Rehabilitation, Rauland, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637363
- Sponsor's protocol ID
- 11-2-2-011
- Other IDs
- 7-11-1347
- Status last verified
- May 2016
- First submitted
- 6 Jul 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen P, Sogaard HJ, Labriola M, Nohr EA, Jensen C. Effectiveness of psychoeducation in reducing sickness absence and improving mental health in individuals at risk of having a mental disorder: a randomised controlled trial. BMC Public Health. 2015 Aug 8;15:763. doi: 10.1186/s12889-015-2087-5.
PubMed 26253219Pedersen P, Sogaard HJ, Yde BF, Labriola M, Nohr EA, Jensen C. Psychoeducation to facilitate return to work in individuals on sick leave and at risk of having a mental disorder: protocol of a randomised controlled trial. BMC Public Health. 2014 Dec 17;14:1288. doi: 10.1186/1471-2458-14-1288.
PubMed 25516423
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation to Sick-listed Individuals With Mental Health Problems
- ClinicalTrials.gov ID
- NCT01637363
- Acronym / sponsor ID
- 11-2-2-011
- Conditions
- Stress, Psychological
- Keywords
- Psychoeducation, Stress, Sickness absence, Psychiatric symptoms, Locus of control, Self reported health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- Sep 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jul 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.
In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms.
The aim of this project is to systematically compare psychoeducation with the various standard offers to sick listed individuals with mental health conditions provided by job centers in four municipalities.
Psychoeducation is employed within the psychiatric healthcare system and is defined as a group based treatment by means of educating participants about psychiatric conditions. In the present project, the employed psychoeducation focuses on psyche and work life, and its purpose is to impart knowledge about psychiatric conditions in order to provide the sick listed individuals with qualifications to understand, and, thereby, improve their own situation. Among others, there will be information about the symptoms of various psychiatric conditions, diagnoses, and treatment options. Furthermore, the participants will learn about specific, useful, cognitive tools in regards to the barriers and difficulties they might experience when reentering the work force and leave sickness absence behind.
The project is designed as a randomized clinical trial in which the participants are offered either 1) psychoeducation as well as the standard offer to sick listed individuals provided by the municipality in which the individual lives or 2) the participants are offered merely the standard offer to sick listed individuals provided by the municipality.
The target group consists of recently sick listed individuals with mental health issues - whether diagnosed or not. The individuals must be inhabitants of the municipalities of Struer, Lemvig, Skive, and Holstebro.
The outcome measure is the determined as the duration of the sickness absence, the severity of the psychiatric condition, self-reported health, and 'locus of control´. These outcome measurements are assessed at baseline and after 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular treatment | No intervention | –This group is offered regular treatment from the job center i.e. exercise, mindfulness |
| Psychoeducation | Experimental | Behavioral: Psychoeducation6 x 2 hours of psychoeducation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A score of 5 or more on SCL-8AD
Key exclusion criteria (5 listed)
- Sick listed due to psychiatric symptoms in a period of 3 months or longer in the last year
- pregnant
- has a flexible job
- receive pension
- not communicating in Danish
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 |
|---|---|---|
| Psychoeducation6 x 2 hours of psychoeducation | Behavioural | Psychoeducation |
Primary outcome
length of sickness absence
Time frame: 6 months after randomization
3 secondary outcomes
Locus of control
Time frame: Baseline, 3 and 6 months after randomization
Self reported health
Time frame: Baseline, 3 and 6 months after randomization
Psychological symptoms
Time frame: Baseline, 3 and 6 months after randomization
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 12 May 2016.
- Derived from this study: PubMed 26253219Pedersen P, Sogaard HJ, Labriola M, Nohr EA, Jensen C. Effectiveness of psychoeducation in reducing sickness absence and improving mental health in individuals at risk of having a mental disorder: a randomised controlled trial. BMC Public Health. 2015 Aug 8;15:763. doi: 10.1186/s12889-015-2087-5.
- Derived from this study: PubMed 25516423Pedersen P, Sogaard HJ, Yde BF, Labriola M, Nohr EA, Jensen C. Psychoeducation to facilitate return to work in individuals on sick leave and at risk of having a mental disorder: protocol of a randomised controlled trial. BMC Public Health. 2014 Dec 17;14:1288. doi: 10.1186/1471-2458-14-1288.
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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.
Hans Jørgen Søgaard, MD, ph.d. study chair
Psychiatric Research Unit West, Regional Psychiatric Services
Pernille Pedersen, MHs principal investigator
Psychiatric Research Unit West, Regional Psychiatric Services
Ellen A Nøhr, ph.d. study chair
Institute of Clinical Research, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Stress, Psychological, run by University of Aarhus at 1 site in Denmark.
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 5 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 12 May 2016. 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 Denmark. 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?
length of sickness absence (time frame: 6 months after randomization). 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 NCT01637363, 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 12 May 2016.