Persistent Delusional DisorderSEEearlyNCT05824117
Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.
A study testing Individual Placement and Support (IPS) in people with Persistent Delusional Disorder and Acute and Transient Psychotic Disorder, Unspecified, run by Charite University, Berlin, Germany at 6 sites in Germany.
Trial summary
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Persistent Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizophrenia
- What is being tested?
- Individual Placement and Support (IPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 6 sitesGermany
- Study dates
- 18 Oct 2022to 31 Mar 2025
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
- sufficient linguistic and intellectual abilities to take part in the study
- interest in competitive employment or/and mainstream education
- written informed consent
Who cannot join
- Learning disability or mental retardation as well as insufficient German language abilities (< A2)
- physical or organic handicap that seriously impede work or educational functioning
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte
Berlin, 10117
Anna Willert, Dr. med., anna.willert@charite.de
- Recruiting
Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban
Berlin, 10967
Dorothea Jäckel, Dipl. Psych., dorothea.jaeckel@vivantes.de
- Recruiting
Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf
Hamburg
Anja Rohenkohl, Dr.
- Recruiting
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
München, Bavaria
Oliver Pogarell, Prof.
- Recruiting
Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau
Reichenau, Baden-Wurttemberg
Daniel Nischk, Dr.
- Recruiting
Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg
Ulm, Bavaria
Nicolas Rüsch, Prof.
About this study
Official title: Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education (SEE): A Randomized Controlled Trial. Acronym: SEEearly
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.
- Conditions
- Persistent Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizophrenia, Schizoaffective Disorder, Other Nonorganic Psychotic Disorders, Unspecified Nonorganic Psychosis
- Being tested
- Individual Placement and Support (IPS)
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement and Support (IPS)Other
IPS is an evidence-based practice for helping people with severe mental illness to gain and maintain competitive employment or/and mainstream education with nine well defined key principles that can be reliably assessed by the IPS Fidelity Scale for Young Adults.
Interventions range from engagement techniques (i.e. motivational interviewing) to individualized education/employment searches and from experience-based educational/employment assessment to benefits in counseling/work incentives planning.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (TAU+SEE) | Experimental | The experimental intervention is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months plus Supported Employment and Education following the Individual Placement and Support model. Receives: Other: Individual Placement and Support (IPS) |
| Control Group (TAU) | No intervention | The control condition is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months (including medical review, pharmacological treatment, and psychosocial support: group programs and social counseling to external government-funded vocational programs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
The primary outcome is the binary indicator "Participating steadily for at least 50% of the 12 month follow-up in competitive employment or/and mainstream education". Days in competitive employment or/and mainstream education will be assessed monthly. Competitive employment is defined as jobs that anyone can apply for regardless of disability status. It comprises part and full-time positions, as well as seasonal or temporary positions depending upon the business needs of the employer. Mainstream education is defined in accordance with OECD as educational programs that are certificating or rather degree bearing and open to the general public.
Measured: 12 months
Secondary outcomes (13)
Length of competitive employment or/and mainstream education
Length of competitive employment or/and mainstream education (measured in days)
Measured: 12 months
Time to first competitive job/mainstream education
Time to first competitive job/mainstream education (measured in days)
Measured: 12 months
Monthly wages
Monthly wages (measured in Euro)
Measured: 12 months
Educational attainment
Educational attainment (measured in degrees/qualifications and ECTS points per semester)
Measured: 12 months
Social return on investment (SROI)
SROI will be computed as the ratio of 'benefits´ to 'total investment´ for each participant and is expressed as percentage. Participants' earnings in both competitive and non-competitive jobs, education, and apprenticeship hereby account as 'benefits´. 'Investments´ are defined as the total vocational program costs and total costs of mental health service per participant.
Measured: 12 months
Subjective quality of life
Subjective quality of life will be measured with the World Health Organization Quality of Life-BREF, a short version of the World Health Organization Quality of Life 100 scale. It's a self-report questionnaire which assesses 4 domains of quality of life: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 4 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).Higher scores indicate a better quality of life.
Measured: 12 months
Psychopathology
Measured with the Positive and Negative Syndrome Scale (PANSS). The PANSS is a clinical interview rating the patient from 1 to 7 on 30 different symptoms. Ranges for the Positive Scale are 7 (minimum of symptoms) to 49 (maximum of symptoms), for the Negative Scale 7 (minimum of symptoms) to 49 (maximum of symptoms) and for the General Psychopathology Scale 16 (minimum of symptoms) to 112 (maximum of symptoms). Ratings are based on the interview as well as reports of family member and/or primary care workers. The interviewer must be trained to a standardized level of reliability.
Measured: 12 months
General substance abuse
General substance abuse (mininum use of 3 times per week per substance) is measured by a modified version of the Addiction Severity Index (ASI).
Measured: 12 months
Cannabis use
Cannabis use is specifically measured using the Daily Sessions, Frequency, Age of Onset and Quantity of Cannabis Use Inventory (DFAQ-CU).
Measured: 12 months
Relapse
Assessed according to DSM 5 relapse definition criteria.
Measured: 12 months
Hospitalization
Number of inpatient stays and duration of stays (measured in days) will be assessed.
Measured: 12 months
Functional impairment
Functional impairment with regard to occupational activity and participation will be assessed using a short version of the International Classification of Functioning, Disability, and Health (Mini-ICF-APP) instrument. The instruments consists of 13 capacity dimensions: adherence to regulations, planning and structuring of tasks, flexibility, applying expertise, capacity to judge and decide, endurance, assertiveness, contacts with others, teamwork capacity, self-care, mobility, proactivity and familiar and intimate relationships. Each dimension is rated from 0 (no impairment) to 4 (full impairment).
Measured: 12 months
Overall functional impairment
Overall level of functioning will be assessed using the Global Assessment of Functioning (GAF) scale. The GAF is a numeric scale to rate social, occupational and psychological functioning of an individual. Scores range from 1 (severely impaired) to 100 (extremely high functioning).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start18 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Delusional DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas Bechdolf, Charite University, Berlin, Germany
- Investigators
- Andreas Bechdolf, Prof., Principal investigator, Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824117
- Sponsor's protocol ID
- 470569697
- Other IDs
- DRKS00029660
- Acronym
- SEEearly
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education (SEE): A Randomized Controlled Trial. Acronym: SEEearly
- ClinicalTrials.gov ID
- NCT05824117
- Acronym / sponsor ID
- SEEearly / 470569697
- Conditions
- Persistent Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizophrenia, Schizoaffective Disorder, Other Nonorganic Psychotic Disorders, Unspecified Nonorganic Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (TAU+SEE) | Experimental | Other: Individual Placement and Support (IPS)The experimental intervention is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months plus Supported Employment and Education following the Individual Placement and Support model. |
| Control Group (TAU) | No intervention | –The control condition is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months (including medical review, pharmacological treatment, and psychosocial support: group programs and social counseling to external government-funded vocational programs). |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
- sufficient linguistic and intellectual abilities to take part in the study
- interest in competitive employment or/and mainstream education
- written informed consent
Key exclusion criteria (2 listed)
- Learning disability or mental retardation as well as insufficient German language abilities (< A2)
- physical or organic handicap that seriously impede work or educational functioning
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 |
|---|---|---|
| Individual Placement and Support (IPS)IPS is an evidence-based practice for helping people with severe mental illness to gain and maintain competitive employment or/and mainstream education with nine well defined key principles that can be reliably assessed by the IPS Fidelity Scale for Young Adults. Interventions range from engagement techniques (i.e. motivational interviewing) to individualized education/employment searches and from experience-based educational/employment assessment to benefits in counseling/work incentives planning. | Other | Intervention Group (TAU+SEE) |
Primary outcome
Primary outcome
Time frame: 12 months
The primary outcome is the binary indicator "Participating steadily for at least 50% of the 12 month follow-up in competitive employment or/and mainstream education". Days in competitive employment or/and mainstream education will be assessed monthly. Competitive employment is defined as jobs that anyone can apply for regardless of disability status. It comprises part and full-time positions, as well as seasonal or temporary positions depending upon the business needs of the employer. Mainstream education is defined in accordance with OECD as educational programs that are certificating or rather degree bearing and open to the general public.
13 secondary outcomes
Length of competitive employment or/and mainstream education
Time frame: 12 months
Time to first competitive job/mainstream education
Time frame: 12 months
Monthly wages
Time frame: 12 months
Educational attainment
Time frame: 12 months
Social return on investment (SROI)
Time frame: 12 months
Subjective quality of life
Time frame: 12 months
Psychopathology
Time frame: 12 months
General substance abuse
Time frame: 12 months
Cannabis use
Time frame: 12 months
Relapse
Time frame: 12 months
Hospitalization
Time frame: 12 months
Functional impairment
Time frame: 12 months
Overall functional impairment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- 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.
Andreas Bechdolf, Prof. principal investigator
Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement and Support (IPS) in people with Persistent Delusional Disorder and Acute and Transient Psychotic Disorder, Unspecified, run by Charite University, Berlin, Germany at 6 sites in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Willert, Dr. med. (+4930130226001, anna.willert@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 12 months). 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 21 Apr 2023.