NCT04672616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

November 17, 2020

Last Update Submit

July 14, 2023

Conditions

Keywords

emerging adulthoodunemploymenttransition

Outcome Measures

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.

    Up to 2 years

Secondary Outcomes (1)

  • Change in Work Ability

    Up to 2 years

Other Outcomes (3)

  • Psychopathological symptoms

    Up to 2 years

  • Structural impairments

    Up to 2 years

  • Interpersonal problems

    Up to 2 years

Study Arms (1)

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

Behavioral: Group psychotherapy

Interventions

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

Group psychotherapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in work integration programme

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZHAW

Zurich, Canton of Zurich, 8005, Switzerland

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy, Group

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Agnes von Wyl, Prof

    University of applied sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

November 17, 2020

First Posted

December 17, 2020

Study Start

November 1, 2020

Primary Completion

July 31, 2022

Study Completion

February 28, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations