Mental DisorderinklusivNCT03328286
Improving Integration of Mentally Burdened Young Adults in the Labour Market
A study testing Weekly group meeting w/psychotherapist in people with Mental Disorder, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
Young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Weekly group meeting w/psychotherapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Aug 2017to 31 Dec 2019
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 to 25
- Participation in work integration programme "Lifetimehealth"
Who cannot join
- Insufficient knowledge of German
- Participant is under guardianship which doesn't allow legal capacity to act
Trial locations and contacts
1 site in 1 country.
About this study
Young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. The causality is unclear: they are either unable to find a job due to a pre-existing mental illness, or their failure in finding a job has contributed to the mental illness.
The Zurich University of Applied Sciences has developed an innovative intervention that includes psychotherapeutic support in a work integration programme. Recognising and treating mental illness early increases the chances of a successful transition to the labour market.
Read the detailed description
Unemployed young people with severe psychological impairments often find no training or workplace, despite the support of various existing services. Many of these young people suffer from a mental illness, but they are often neither diagnosed nor treated. In Switzerland, this is reflected in the increasing number of young people who receive a disability pension. To make matters worse, young people often do not use the necessary psychotherapeutic treatment. An explanation for this may be the fear of being stigmatized or the lack of insight that help is needed al all. A group of researchers has analyzed the dossiers of 400 young people who were given a disability pension 2010 and 2013 due to mental problems. They have found that the consultation often took place before the 23rd year of age and in 84% of the cases whole disability pensions were given. In the analysed cases only 14% had completed vocational training. The authors propose various measures, including prioritizing the completion of a professional apprenticeship, a systematic interdisciplinary assessment, a joint, longer-lasting integration management, as well as early detection and intervention in psychological disorders in school and vocational training. Our intervention meets these requirements. Together with lifetime health, a provider work working integrations programs, we have developed a low-threshold psychotherapeutic offer in addition to the existing work integration program. With this intervention we hope to reach the following goals. First: Facilitate the transition into a professional apprenticeship by increasing work ability and other variables. Secondly, the integration and cooperation of a psychotherapist in the work integration program allows for a systematic interdisciplinary assessment; third, the support of a psychotherapist offers a joint, longer-lasting integration management.
- Conditions
- Mental Disorder
- Being tested
- Weekly group meeting w/psychotherapist
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly group meeting w/psychotherapistBehavioural
Introduce a Psychotherapist in a work Integration program to further support Young adults in Job search and at the same time offering psychotherapeutic counselling. The participants will have a weekly meeting lasting 1.5 hour and additionally the can have 5 private counselling sessions with the psychotherapist if they wish
| Study group | Role | What they receive |
|---|---|---|
| Weekly group meeting w/psychotherapist | Experimental | All the participants fulfilling the eligibility criteria are asked to take part in an additional Intervention. The Intervention is a weekly group Meeting with a psychotherapist to discuss issues or Problems the Group members have Receives: Behavioral: Weekly group meeting w/psychotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Work Ability
Increase in work ability of participants, measured with the Work Ability Index. The Work Ability Index (WAI) is an instrument used in occupational health care and research to assess work ability of workers during health examinations and workplace surveys. The purpose of WAI is to help define necessary actions to maintain and promote work ability. The scoring system of the questionnaire categorises work ability, with recommendations for action provided for each category. Appropriate action can then be taken to prevent declining work ability.Each answer has a different score, with users calculating their total points to determine their final score. The minimum is 7, the maximum is 49. The four categories of scores and the objectives of the measures to be taken are as follows:
- 7-27 points (bad) - restore work ability;
- 28-36 points (moderate) - improve work ability;
- 37-43 points (good) - support work ability;
- 44-49 points (very good) - support work ability.
Measured: Up to 2 years
Secondary outcomes (1)
Change in Self-esteem
Increase in self-esteem of participants, measured with the Rosenberg Self-esteem Scale (SES). The SES is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self.
Scores are calculated as follows:
•For items 1, 2, 4, 6, and 7: Strongly agree = 3 Agree = 2 Disagree = 1 Strongly disagree = 0
•For items 3, 5, 8, 9, and 10 (which are reversed in valence): Strongly agree = 0 Agree = 1 Disagree = 2 Strongly disagree = 3
The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start15 Aug 2017
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filomena Sabatella, Zurich University of Applied Sciences
- Investigators
- Agnes von Wyl, Prof, Principal investigator, University of applied sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328286
- Sponsor's protocol ID
- 2017-00936
- Other IDs
- 2017
- Acronym
- inklusiv
- Status last verified
- Jan 2020
- First submitted
- 26 Sep 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabatella F, von Wyl A. Improving Work Ability of Mentally Burdened Emerging Adults in Vocational Integration Programs: A Study Protocol. Front Psychol. 2019 Jun 19;10:1391. doi: 10.3389/fpsyg.2019.01391. eCollection 2019.
PubMed 31275206
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Integration of Mentally Burdened Young Adults in the Labour Market
- ClinicalTrials.gov ID
- NCT03328286
- Acronym / sponsor ID
- inklusiv / 2017-00936
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- 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.
Young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. The causality is unclear: they are either unable to find a job due to a pre-existing mental illness, or their failure in finding a job has contributed to the mental illness.
The Zurich University of Applied Sciences has developed an innovative intervention that includes psychotherapeutic support in a work integration programme. Recognising and treating mental illness early increases the chances of a successful transition to the labour market.
Detailed description
Unemployed young people with severe psychological impairments often find no training or workplace, despite the support of various existing services. Many of these young people suffer from a mental illness, but they are often neither diagnosed nor treated. In Switzerland, this is reflected in the increasing number of young people who receive a disability pension. To make matters worse, young people often do not use the necessary psychotherapeutic treatment. An explanation for this may be the fear of being stigmatized or the lack of insight that help is needed al all. A group of researchers has analyzed the dossiers of 400 young people who were given a disability pension 2010 and 2013 due to mental problems. They have found that the consultation often took place before the 23rd year of age and in 84% of the cases whole disability pensions were given. In the analysed cases only 14% had completed vocational training. The authors propose various measures, including prioritizing the completion of a professional apprenticeship, a systematic interdisciplinary assessment, a joint, longer-lasting integration management, as well as early detection and intervention in psychological disorders in school and vocational training. Our intervention meets these requirements. Together with lifetime health, a provider work working integrations programs, we have developed a low-threshold psychotherapeutic offer in addition to the existing work integration program. With this intervention we hope to reach the following goals. First: Facilitate the transition into a professional apprenticeship by increasing work ability and other variables. Secondly, the integration and cooperation of a psychotherapist in the work integration program allows for a systematic interdisciplinary assessment; third, the support of a psychotherapist offers a joint, longer-lasting integration management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekly group meeting w/psychotherapist | Experimental | Behavioral: Weekly group meeting w/psychotherapistAll the participants fulfilling the eligibility criteria are asked to take part in an additional Intervention. The Intervention is a weekly group Meeting with a psychotherapist to discuss issues or Problems the Group members have |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 16 to 25
- Participation in work integration programme "Lifetimehealth"
Key exclusion criteria (2 listed)
- Insufficient knowledge of German
- Participant is under guardianship which doesn't allow legal capacity to act
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 |
|---|---|---|
| Weekly group meeting w/psychotherapistIntroduce a Psychotherapist in a work Integration program to further support Young adults in Job search and at the same time offering psychotherapeutic counselling. The participants will have a weekly meeting lasting 1.5 hour and additionally the can have 5 private counselling sessions with the psychotherapist if they wish | Behavioural | Weekly group meeting w/psychotherapist |
Primary outcome
Change in Work Ability
Time frame: Up to 2 years
Increase in work ability of participants, measured with the Work Ability Index. The Work Ability Index (WAI) is an instrument used in occupational health care and research to assess work ability of workers during health examinations and workplace surveys. The purpose of WAI is to help define necessary actions to maintain and promote work ability. The scoring system of the questionnaire categorises work ability, with recommendations for action provided for each category. Appropriate action can then be taken to prevent declining work ability.Each answer has a different score, with users calculating their total points to determine their final score. The minimum is 7, the maximum is 49. The four categories of scores and the objectives of the measures to be taken are as follows: * 7-27 points (bad) - restore work ability; * 28-36 points (moderate) - improve work ability; * 37-43 points (good) - support work ability; * 44-49 points (very good) - support work ability.
1 secondary outcome
Change in Self-esteem
Time frame: Up to 2 years
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 27 Jan 2020.
- Derived from this study: PubMed 31275206Sabatella F, von Wyl A. Improving Work Ability of Mentally Burdened Emerging Adults in Vocational Integration Programs: A Study Protocol. Front Psychol. 2019 Jun 19;10:1391. doi: 10.3389/fpsyg.2019.01391. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Agnes von Wyl, Prof principal investigator
University of applied sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly group meeting w/psychotherapist in people with Mental Disorder, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 2 inclusion and 2 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 27 Jan 2020. 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 Switzerland. 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?
Change in Work Ability (time frame: Up to 2 years). 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 NCT03328286, which also lists 1 linked publication.
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 27 Jan 2020.