Improving functional and clinical recovery by combining Individual Placement and Support (IPS) and Motivational Interviewing-based Adherence Therapy (AT) in patients with early psychosis
Organizational Data
- DRKS-ID:
- DRKS00018107
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-01-21
- Last update in DRKS:
- 2023-03-29
- Registration type:
- Retrospective
Acronym/abbreviation of the study
IPS-AT
URL of the study
No Entry
Brief summary in lay language
The aim of the study is to examine whether the combination of Individual Placement and Support (IPS) and motivational interviewing-based adherence therapy will enable patients to more quickly and sustainably receive and maintain training, study or work in the primary labor market , It will also examined if and how attitudes and beliefs regarding mental illness and its therapies, disease-related symptoms and limitations, quality of life and substance use change as a result of treatment. It also examined the medical costs generated during the study period.
Brief summary in scientific language
Competitive employment and professional education are the expressed primary treatment goals of people with early psychosis but they have rarely access to effective vocational interventions. However, until today, there is no evidence based intervention programme which focuses on both functional and clinical recovery for people with early psychosis. Thus the aim of the present study is to evaluate an innovative intervention which focuses on functional recovery like Individual Placement and Support (IPS) and an intervention which focuses on clinical recovery like Motivational Interviewing-based Adherence Therapy (AT) combined in addition to Early Intervention (EI) in order to further improve functional and clinical recovery in young people with early psychosis with particular reference to long-acting injectable antipsychotic treatment. This study is designed as a randomised controlled trial to investigate efficacy of the combination of IPS and AT in early psychosis patients. The primary outcome criteria is functional recovery. Secondary outcomes include adherence factors like attitudes towards antipsychotic medication, symptoms and additional indicators of clinical and functional recovery. Though IPS and AT has shown good results in early psychosis, there has not been any studies, that have investigate the efficacy of the combination. IPS needs an adherent patient to achieve good results and successful integration at work or school is a main motivation for adherence therefore the combination of IPS and AT should be more effective than each intervention alone.
Health condition or problem studied
- Free text:
- Clinical diagnosis of schizophrenia-spectrum disorders (DSM-V criteria)
- ICD10:
- F20-F29 - Schizophrenia, schizotypal and delusional disorders
- ICD10:
- F30.2 - Mania with psychotic symptoms
- ICD10:
- F31.2 - Bipolar affective disorder, current episode manic with psychotic symptoms
- ICD10:
- F31.5 - Bipolar affective disorder, current episode severe depression with psychotic symptoms
- ICD10:
- F32.3 - Severe depressive episode with psychotic symptoms
- ICD10:
- F33.3 - Recurrent depressive disorder, current episode severe with psychotic symptoms
- Free text:
- ICD-10 codes F12.5, F13.5, F14.5, F16.5, F19.5
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Individual Placement and Support (IPS) and Motivational Interviewing based Adherance Therapy (AT) in addition to early interventions in patients with psychosis
- Arm 2:
- Treatment as usual
Endpoints
- Primary outcome:
- Rate of competitive employment or/and mainstream education in the 12-month follow up (monthly evaluation)
- Secondary outcome:
- 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)
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Vivantes Klinikum Am Urban, Klinik für Psychiatrie, Psychotherapie und Psychosomatik mit FRITZ am Urban & soulspace Berlin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2017-08-23
- Planned study completion date:
- 2022-12-22
- Actual Study Completion Date:
- 2022-11-22
- Target Sample Size:
- 84
- Final Sample Size:
- 84
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 35 Years
- Additional 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
- 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;
Addresses
Primary Sponsor
- Address:
- Otsuka Pharma GmbHEuropa-Allee 5260327 Frankfurt am MainGermany
- Telephone:
- +49 173 6536060
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Vivantes Klinikum Am Urban und Vivantes Klinikum im FriedrichshainKliniken für Psychiatrie, Psychotherapie und Psychosomatik mit FRITZ am Urban & soulspaceDr. Karolina LeopoldDieffenbachstr. 110967 BerlinGermany
- Telephone:
- +49 30 130226017
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vivantes.de/kau/psych/
Contact for Public Queries
- Address:
- Vivantes Klinikum Am Urban und Vivantes Klinikum im FriedrichshainKliniken für Psychiatrie, Psychotherapie und Psychosomatik mit FRITZ am Urban & soulspaceDorothea JäckelDieffenbachstr. 110967 BerlinGermany
- Telephone:
- +49 30 130226016
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vivantes.de/kau/psych/
Principal Investigator
- Address:
- Vivantes Klinikum Am Urban und Vivantes Klinikum im FriedrichshainKliniken für Psychiatrie, Psychotherapie und Psychosomatik mit FRITZ am Urban & soulspaceDr. Karolina LeopoldDieffenbachstr. 110967 BerlinGermany
- Telephone:
- +49 30 130226017
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vivantes.de/kau/psych/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Otsuka Pharma GmbHEuropa-Allee 5260327 Frankfurt am MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer BerlinFriedrichstraße 1610696 BerlinGermany
- Telephone:
- (+49)30-408062601
- Fax:
- (+49)30-408062298
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-05-18
- Ethics committee number:
- Eth-13/17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-07-05
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry