Mental DisorderIpNCT04672616
Inklusiv Plus: Mental Health Of Unemployed Adolescents And Young Adults
A study testing Group psychotherapy in people with Mental Disorder, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
The expansion project "Inclusive Plus", which is financed by Innosuisse, is based on a pilot project. The psychotherapeutic offer developed in the previous project for psychologically burdened adolescents and young adults to support them in their professional integration was revised and supplemented and is being… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2020to 28 Feb 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participation in work integration programme
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
The expansion project "Inclusive Plus", which is financed by Innosuisse, is based on a pilot project. The psychotherapeutic offer developed in the previous project for psychologically burdened adolescents and young adults to support them in their professional integration was revised and supplemented and is being reviewed in this project. In addition to the group psychotherapeutic intervention, 5 one-on-one interviews are offered as needed. In addition, regular further training courses on mental health and illness in adolescence are implemented. And finally, a conference is to promote cooperation between referring physicians and bridge offers. The intervention will be implemented in 5 cantons (Zurich, Berne, Lucerne, St. Gallen, Appenzell Ausserrhoden) and in 7 different bridge services. The program is aimed at adolescents and young adults between 16 and 29 years of age who have sufficient knowledge of German. Participation is voluntary and the group size for the psychotherapy group is limited to 8 participants. The main question is whether the integration of young people with mental stress into the labor market is more successful. At three points in time (entry, exit, six months after exit) changes in selected indicators (including work ability, mental health, functional status, behaviour in seeking help) are measured. In addition, changes in the groups of participants will be surveyed. The implementation of the psychotherapy groups in the respective bridge offers will take place in autumn 2020, and the study will be completed with the last follow-up by the end of 2022.
Read the detailed description
In Switzerland, almost one in six young people has no further professional solution after the compulsory school years. So-called bridge offers have been created for these young people. Despite these offers, adolescents and young adults with multiple burdens often do not find a training place or job. Young people who have not found a follow-up solution are significantly more likely to suffer from mental impairments and disorders than those who begin an apprenticeship or attend secondary school. According to Sabatella and von Wyl, this may be due on the one hand to the fact that a lack of an apprenticeship places a psychological burden on them. On the other hand, it can be assumed that many young people do not find an apprenticeship or job precisely because of a mental illness. Furthermore, the psychological impairments and illnesses are often not recognized or treated. This is probably due to the fact that young people often fail to make use of appropriate psychotherapeutic services, on the one hand because of the fear of being stigmatized, and on the other hand because they often seem to lack the insight to need and make use of help. The problem of mental stress and illness in adolescence is also reflected in IV consultations. The rate of new pensioners is significantly higher among 18 to 19-year-olds. Early treatment without delay can positively influence the course of an illness. In contrast, it has been shown that the longer people wait to treat a mental illness, the greater the risk of chronification. Therefore, treatment of mental illness is especially important for young people. The further development of these young people is not - as often feared - impaired. On the contrary, their professional and personal future prospects become more positive. As a result, cases of full retirement can be reduced, which has a positive effect on health costs.
Against this background, the pilot project "inclusive", which preceded this project and was financed by the Gebert Rüf Foundation, was carried out. In cooperation with the bridge offer lifetime health, an innovative approach for a better integration of work was developed, applied and tested for two years: The existing care team of lifetime health was supplemented by a psychotherapist who conducted a 90-minute weekly group psychotherapy session with the young clients of lifetime health. He was also in contact with the team and the clients as needed.
This (group) psychotherapeutic offer developed in the previous project for mentally burdened adolescents and young adults to support them in their professional integration was revised and supplemented. In the current project phase it is being implemented in 7 further bridge offers in five cantons. For an initial assessment of whether such an offer is also suitable for adults, a group is also offered for adults at one of the locations. The project is financed by Innosuisse.
- Conditions
- Mental Disorder
- Being tested
- Group psychotherapy
- Keywords
- emerging adulthood, unemployment, transition
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group psychotherapyBehavioural
The intervention is a group psychotherapeutic offer for mentally burdened adolescents and young adults to support their professional integration.
| Study group | Role | What they receive |
|---|---|---|
| Group psychotherapy | Experimental | Weekly group meeting w/psychotherapist: 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: Group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social functioning status
The social functioning status is assessed using the Mini-ICF-APP (Linden et al., 2009), based on the International Classification of Functioning, Disability and Health (ICF) published by the WHO. The ICF is a complex document and the Mini-ICFAPP (Mini-ICF-Rating for limitations of Activities and Participation in Psychological disorders) was developed to allow the reliable and rapid measurement and recording of impairments of capacity. It is used in this study as a self-assessment tool to describe and quantify activity and participation impairments in the context of mental illness. 13 areas are rated on a five-point Likert-scale (0 =no impairment, 1 =mild impairment, 2 =moderate disability, 3 = severe disability, 4 =total disability). The self-rating scores will then be averaged in order to have one overall score and then this overall score will be compared on three different time points (pre-treatment, post treatment and 6 months follow up). High scores here mean high impairment.
Measured: Up to 2 years
Secondary outcomes (1)
Change in Work Ability
The Work Ability Index (WAI) is an instrument used in occupational health care and research to assess work ability of workers. 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. This overall score will be compared on three different time points (pre-treatment, post treatment and 6 month follow up).
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 posted17 Dec 2020
- Study start1 Nov 2020
- Primary completion31 Jul 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 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
- NCT04672616
- Sponsor's protocol ID
- 2020-02184
- Acronym
- Ip
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2020
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inklusiv Plus: Mental Health Of Unemployed Adolescents And Young Adults
- ClinicalTrials.gov ID
- NCT04672616
- Acronym / sponsor ID
- Ip / 2020-02184
- Conditions
- Mental Disorder
- Keywords
- emerging adulthood, unemployment, transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (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.
The expansion project "Inclusive Plus", which is financed by Innosuisse, is based on a pilot project. The psychotherapeutic offer developed in the previous project for psychologically burdened adolescents and young adults to support them in their professional integration was revised and supplemented and is being reviewed in this project. In addition to the group psychotherapeutic intervention, 5 one-on-one interviews are offered as needed. In addition, regular further training courses on mental health and illness in adolescence are implemented. And finally, a conference is to promote cooperation between referring physicians and bridge offers. The intervention will be implemented in 5 cantons (Zurich, Berne, Lucerne, St. Gallen, Appenzell Ausserrhoden) and in 7 different bridge services. The program is aimed at adolescents and young adults between 16 and 29 years of age who have sufficient knowledge of German. Participation is voluntary and the group size for the psychotherapy group is limited to 8 participants. The main question is whether the integration of young people with mental stress into the labor market is more successful. At three points in time (entry, exit, six months after exit) changes in selected indicators (including work ability, mental health, functional status, behaviour in seeking help) are measured. In addition, changes in the groups of participants will be surveyed. The implementation of the psychotherapy groups in the respective bridge offers will take place in autumn 2020, and the study will be completed with the last follow-up by the end of 2022.
Detailed description
In Switzerland, almost one in six young people has no further professional solution after the compulsory school years. So-called bridge offers have been created for these young people. Despite these offers, adolescents and young adults with multiple burdens often do not find a training place or job. Young people who have not found a follow-up solution are significantly more likely to suffer from mental impairments and disorders than those who begin an apprenticeship or attend secondary school. According to Sabatella and von Wyl, this may be due on the one hand to the fact that a lack of an apprenticeship places a psychological burden on them. On the other hand, it can be assumed that many young people do not find an apprenticeship or job precisely because of a mental illness. Furthermore, the psychological impairments and illnesses are often not recognized or treated. This is probably due to the fact that young people often fail to make use of appropriate psychotherapeutic services, on the one hand because of the fear of being stigmatized, and on the other hand because they often seem to lack the insight to need and make use of help. The problem of mental stress and illness in adolescence is also reflected in IV consultations. The rate of new pensioners is significantly higher among 18 to 19-year-olds. Early treatment without delay can positively influence the course of an illness. In contrast, it has been shown that the longer people wait to treat a mental illness, the greater the risk of chronification. Therefore, treatment of mental illness is especially important for young people. The further development of these young people is not - as often feared - impaired. On the contrary, their professional and personal future prospects become more positive. As a result, cases of full retirement can be reduced, which has a positive effect on health costs.
Against this background, the pilot project "inclusive", which preceded this project and was financed by the Gebert Rüf Foundation, was carried out. In cooperation with the bridge offer lifetime health, an innovative approach for a better integration of work was developed, applied and tested for two years: The existing care team of lifetime health was supplemented by a psychotherapist who conducted a 90-minute weekly group psychotherapy session with the young clients of lifetime health. He was also in contact with the team and the clients as needed.
This (group) psychotherapeutic offer developed in the previous project for mentally burdened adolescents and young adults to support them in their professional integration was revised and supplemented. In the current project phase it is being implemented in 7 further bridge offers in five cantons. For an initial assessment of whether such an offer is also suitable for adults, a group is also offered for adults at one of the locations. The project is financed by Innosuisse.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group psychotherapy | Experimental | Behavioral: Group psychotherapyWeekly group meeting w/psychotherapist: 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in work integration programme
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 |
|---|---|---|
| Group psychotherapyThe intervention is a group psychotherapeutic offer for mentally burdened adolescents and young adults to support their professional integration. | Behavioural | Group psychotherapy |
Primary outcome
Social functioning status
Time frame: Up to 2 years
The social functioning status is assessed using the Mini-ICF-APP (Linden et al., 2009), based on the International Classification of Functioning, Disability and Health (ICF) published by the WHO. The ICF is a complex document and the Mini-ICFAPP (Mini-ICF-Rating for limitations of Activities and Participation in Psychological disorders) was developed to allow the reliable and rapid measurement and recording of impairments of capacity. It is used in this study as a self-assessment tool to describe and quantify activity and participation impairments in the context of mental illness. 13 areas are rated on a five-point Likert-scale (0 =no impairment, 1 =mild impairment, 2 =moderate disability, 3 = severe disability, 4 =total disability). The self-rating scores will then be averaged in order to have one overall score and then this overall score will be compared on three different time points (pre-treatment, post treatment and 6 months follow up). High scores here mean high impairment.
1 secondary outcome
Change in Work Ability
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 17 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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 Group psychotherapy 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 1 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 17 Jul 2023. 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?
Social functioning status (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?
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 17 Jul 2023.