ClinicalTrials.gg
CompletedNCT04672616IpUpdated Jul 17, 2023

Inklusiv Plus: Mental Health Of Unemployed Adolescents And Young Adults

An interventional study of Group psychotherapy in Mental Disorder, sponsored by Zurich University of Applied Sciences. Completed at 1 site in Switzerland. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Zurich University of Applied Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mental Disorder

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Keywords

  • emerging adulthood
  • unemployment
  • transition
03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's enrollment of 250 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Zurich University of Applied Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participation in work integration programme

Exclusion criteria

Exclusion Criteria:

  • Insufficient knowledge of German
  • Participant is under guardianship which doesn't allow legal capacity to act
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Group psychotherapy

    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

    Behavioral: Group psychotherapy

Interventions

  • BehavioralGroup psychotherapy

    The intervention is a group psychotherapeutic offer for mentally burdened adolescents and young adults to support their professional integration.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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).

    Time frame: Up to 2 years

Other outcomes

  1. Psychopathological symptoms

    Psychopathological symptoms are measured using the Brief Symptom Checklist (BSCL; Franke, 2000). The BSCL records any subjective impairment caused by physical and especially psychological symptoms The BSCL consists of 53 items, i.e. statements to which the patient is to say whether they apply not at all, a little, moderately, strongly or very strongly (not at all = 0, very strongly = 4). Higher values indicate greater stress. The psychological stress is recorded on nine scales (aggressiveness/ hostility, anxiety, depression, paranoid thinking, phobic anxiety, psychoticism, somatization, insecurity in social contact, compulsiveness) and three global parameters.

    Time frame: Up to 2 years

  2. Structural impairments

    With the Operationalized Psychodynamic Diagnostics Structural Questionnaire (OPD-SFK; Ehrenthal et al., 2015) structural limitations of personality can be quickly mapped in the self-assessment with 12 items. The questions are answered according on a Likert scale: 0=not at all true, 1=rather not true, 2=partly true, 3=rather true, 4=totally true. The Self-perception subscale links aspects of the self with structural skills of emotion regulation, the Contact Shaping subscale links interactional skills with aspects of self-uncertainty. The Relationship Model subscale maps the representation of relationship experiences, associated with corresponding expectations for new relationships. The value range of the sum score is from 0 (="highest structural level") to 48 (="lowest structural level").

    Time frame: Up to 2 years

  3. Interpersonal problems

    Interpersonal difficulties are recorded with the Inventory of Interpersonal Problems (IIP-D; Horowitz et al., 2016). The scale comprises 32 items. The IIP identifies respondents as "hard to do" (i.e., behavioral inhibitions) or "does too much" (i.e., behavioral excesses) on a 0 (not at all) to 4 (extremely) Likert-type scale. It provides an overall score and 8 subscale scores: domineering, vindictive, cold, socially avoidant, non-assertive, exploitable, overly nurturant, and intrusive. The overall score shows the extent of interpersonal problems.

    Time frame: Up to 2 years

07

Study locations

1 site
  • ZHAW
    Zürich, Zurich 8005, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Jul 2022, 20 months.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 20 months is below that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2020
First posted
Dec 17, 2020
StartActual
Nov 1, 2020
Primary completionActual
Jul 31, 2022
CompletionActual
Feb 28, 2023
Last update
Jul 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04672616
Lead sponsor
Zurich University of Applied Sciences
Responsible party
Filomena Sabatella (Prinicipal Investigator, Zurich University of Applied Sciences) — Principal investigator
First posted
Dec 17, 2020
Start date
Nov 1, 2020
Primary completion
Jul 31, 2022
Completion
Feb 28, 2023
Last update
Jul 17, 2023

Study contacts

Agnes von Wyl, Prof
principal investigator · University of applied sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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