Bipolar Affective Disorder Clinical Trial
Official title:
Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
Verified date | March 2024 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.
Status | Completed |
Enrollment | 717 |
Est. completion date | February 2019 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: Psychosis within the schizophrenic spectrum (F 2, International Classification of Diseases (ICD 10)). Severe depression (F33, ICD-10) or Bipolar disorder (F31, ICD-10) and minimum 3 years psychiatric treatment. Motivated for employment or education. 18 to 65 years old. Participants must speak and understand Danish. Exclusion Criteria: Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment) |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Centre Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | Copenhagen Municipality, Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, Odense Municipality, Odense University Hospital, Silkeborg Municipality |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hours in competitive employment or education | Measured at 18 month | ||
Secondary | In competitive employment or education at some point during follow up period | Measured at 18 month follow-up | ||
Secondary | Days to first employment or beginning of education | Measured at 18 month follow-up | ||
Secondary | Average monthly earnings in follow-up period | Measured at 18 month follow-up | ||
Secondary | Hours of work per week among those who obtain competitive employment during the follow-up period | Measured at 18 month follow-up | ||
Secondary | Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS) | Measured at 18 month follow-up | ||
Secondary | Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC) | Measured at 18 month follow-up | ||
Secondary | Functioning measured with Global Assessment of Functioning (GAF) | Measured at 18 month follow-up | ||
Secondary | Functioning measured with Personal and Social Performance (PSP) | Measured at 18 month follow-up | ||
Secondary | Quality of life measured with SF-12 | Measured at 18 month follow-up | ||
Secondary | Empowerment measured with Empowerment Scale | Measured at 18 month follow-up | ||
Secondary | Self-efficacy measured with General self-efficacy scale (GSE) | Measured at 18 month follow-up | ||
Secondary | Self-esteem measured with The Rosenberg Self-Esteem scale | Measured at 18 month follow-up |
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