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Improving functional and clinical recovery by combining Individual Placement and Support (IPS) and Motivational Interviewing-based Adherence Therapy (AT) in patients with early psychosis

Improving functional and clinical recovery by combining Individual Placement and Support (IPS) and Motivational Interviewing-based Adherence Therapy (AT) in patients with early psychosis - IPS-AT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00018107
Enrollment
84
Registered
2021-01-21
Start date
2017-08-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical diagnosis of schizophrenia-spectrum disorders (DSM-V criteria) ICD-10 codes F12.5, F13.5, F14.5, F16.5, F19.5 F20-F29 F30.2 F31.2 F31.5 F32.3 F33.3

Interventions

Group 1: Individual Placement and Support (IPS) and Motivational Interviewing based Adherance Therapy (AT) in addition to early interventions in patients with psychosis Group 2: Treatment as usual

Sponsors

Otsuka Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: - have a stabilised mental disorder in accordance with clinical diagnosis of schizophrenia-spectrum disorders (DSM-V criteria) (contains the following ICD-10 diagnosis: psychotic disorder due to psychoacive substance use F1x.5, schizophrenia, schizotypal and delusional disorders F2x, mania with psychotic symptoms F30.2, Bipolar affective disorder, current episode manic with psychotic symptoms F30.2,5, and severe depressive episode with psychotic symptoms F32.3, F33.3); - Early Phase of disease: Duration of disease is no longer then 5 years or the first contact due this disease in a medical care Center is no longer than 5 years ago; - participation in the FRITZ therapy program - express an interest in competitive employment or professional education; - sufficient verbal and intellectual skills to participate in the study; - written consent after enlightenment

Exclusion criteria

Exclusion criteria: - learning disability (IQ < 70); - without sufficient German language ability (level a1); - primary substance abuse disorder; - physical or organic handicap that seriously impeded work; - unwillingness to attend regular outpatient treatment;

Design outcomes

Primary

MeasureTime frame
Rate of competitive employment or/and mainstream education in the 12-month follow up (monthly evaluation)

Secondary

MeasureTime frame
4 measuring time points: T0 = at inclusion T1 = 3 month after inclusion; T2 = 3 month after T1; T3 = 6 month after T2; The functional and clinical recovery is operationalized through: - Capacity and social functioning: (Mini-ICF-APP->T0,T1,T2/ Specific level of functioning scale - SLOF/ Global Assessment of Functioning- GAF -> T0,T1,T2/ Vocation and location Index -> T0,T1,T2) - Quality of life (Modular System for Quality of Life - MSLQ-R ->T0,T1,T2) - Attitude towards antipsychotic medication Insight and Treatment Attitude Questionnaire - ITAQ -> T0,T1,T2/ Drug Attitude Inventory - DAI-10 -> T0,T1,T2) -Adherence to the antipsychotic medication (Dose, application, long-acting injectable antipsychotics, and substance of psychopharmacotherapy -> T0,T1,T2/ UKU side effect Rating scale -> T0,T1,T2/ Adherence Rating Scale -> T0,T1,T2) - Symptom severity (Hospitalization and mental health service use: i) admission (hospital, day-care unit, home treatment) ii) days in treatment iii) number of psychiatric/psychotherapeutic consultations (outpatient) iv) medical costs -> T1, T2, T3/ Addiction Severity Index - ASI -> T0,T1,T2/ Positive and Negative Syndrome Scale - PANSS -> T0,T1,T2)

Countries

Germany

Contacts

Public ContactDorothea Jäckel

Vivantes Klinikum Am Urban und Vivantes Klinikum im FriedrichshainKliniken für Psychiatrie, Psychotherapie und Psychosomatik mit FRITZ am Urban & soulspace

dorothea.jaeckel@vivantes.de+49 30 130226016

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026