Improving Work Outcome for People With Severe Mental Illness
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01722344 |
|
Recruitment Status :
Completed
First Posted : November 6, 2012
Last Update Posted : September 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia, Schizotypal and Delusional Disorders Bipolar Affective Disorder Recurrent Depressive Disorder | Behavioral: Individual Placement and support (IPS) Behavioral: IPS plus | Not Applicable |
Individual Placement and Support (IPS) is established as the most effective vocational intervention available for persons with severe mental illness,and the intervention is widely recognized as an evidence-based practice. Despite evidence, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Research has suggested that integrating methods such as cognitive remediation and social skills training could reduce such limitations. Further, there has not been conducted any randomized controled trials with IPS in Scandinavian countries with highly developed and generous social security and welfare systems, and with high thresholds to the open labour market.
The aim of this study is to investigate the effectiveness of IPS in Denmark and compare effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. Standard intervention.
The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced with cognitive remediation and work-related social skills training, consists of 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 717 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial |
| Actual Study Start Date : | October 2012 |
| Actual Primary Completion Date : | August 2017 |
| Actual Study Completion Date : | February 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Individual Placement and Support (IPS) |
Behavioral: Individual Placement and support (IPS)
IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling |
|
Experimental: IPS plus
Individual Placement and Support plus cognitive remediation and work-related social skills training
|
Behavioral: Individual Placement and support (IPS)
IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling Behavioral: IPS plus Individual Placement and Support + cognitive remediation and work-related social skills training, consists of the IPS intervention + 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training. |
| No Intervention: Standard intervention |
- Hours in competitive employment or education [ Time Frame: Measured at 18 month ]
- In competitive employment or education at some point during follow up period [ Time Frame: Measured at 18 month follow-up ]
- Days to first employment or beginning of education [ Time Frame: Measured at 18 month follow-up ]
- Average monthly earnings in follow-up period [ Time Frame: Measured at 18 month follow-up ]
- Hours of work per week among those who obtain competitive employment during the follow-up period [ Time Frame: Measured at 18 month follow-up ]
- Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS) [ Time Frame: Measured at 18 month follow-up ]
- Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC) [ Time Frame: Measured at 18 month follow-up ]
- Functioning measured with Global Assessment of Functioning (GAF) [ Time Frame: Measured at 18 month follow-up ]
- Functioning measured with Personal and Social Performance (PSP) [ Time Frame: Measured at 18 month follow-up ]
- Quality of life measured with SF-12 [ Time Frame: Measured at 18 month follow-up ]
- Empowerment measured with Empowerment Scale [ Time Frame: Measured at 18 month follow-up ]
- Self-efficacy measured with General self-efficacy scale (GSE) [ Time Frame: Measured at 18 month follow-up ]
- Self-esteem measured with The Rosenberg Self-Esteem scale [ Time Frame: Measured at 18 month follow-up ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722344
| Denmark | |
| Mental Health Centre Copenhagen | |
| Copenhagen, Denmark, 2400 | |
| Study Director: | Lene F Eplov, MD, Phd | Copenhagen University Hospital, Mental Health Centre Copenhagen | |
| Principal Investigator: | Merete Nordentoft, Professor | Copenhagen University Hospital, Mental Health Centre Copenhagen | |
| Principal Investigator: | Elsebeth Stenager, MD, Phd | Department of Psychiatry, Odense, The University of Southern Denmark. | |
| Principal Investigator: | Bent Nielsen, Professor | Department of Psychiatry, Odense, The University of Southern Denmark |
| Responsible Party: | Mental Health Centre Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01722344 |
| Other Study ID Numbers: |
PCK-2012-CT-2912 |
| First Posted: | November 6, 2012 Key Record Dates |
| Last Update Posted: | September 8, 2021 |
| Last Verified: | September 2021 |
|
Severe mental illness Vocational rehabilitation Supported employment |
Individual placement and support Cognitive remediation Social skill training |
|
Disease Schizophrenia Depressive Disorder Mood Disorders Bipolar Disorder |
Schizophrenia, Paranoid Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders |