Schizophrenia, Schizotypal and Delusional DisordersNCT01722344
Improving Work Outcome for People With Severe Mental Illness
A study testing Individual Placement and support (IPS) and IPS plus in people with Schizophrenia, Schizotypal and Delusional Disorders and Bipolar Affective Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder
- What is being tested?
- Individual Placement and support (IPS) and IPS plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 717 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Feb 2019
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder
- Being tested
- Individual Placement and support (IPS), IPS plus
- Keywords
- Severe mental illness, Vocational rehabilitation, Supported employment, Individual placement and support, Cognitive remediation, Social skill training
- Medical subject headings
- Schizophrenia, Schizophrenia, Paranoid, Bipolar Disorder, Depressive Disorder, 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)Behavioural
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
IPS plusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Not described Receives: Behavioral: Individual Placement and support (IPS) |
| IPS plus | Experimental | Individual Placement and Support plus cognitive remediation and work-related social skills training Receives: Behavioral: Individual Placement and support (IPS); Behavioral: IPS plus |
| Standard intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours in competitive employment or education
Measured: Measured at 18 month
Secondary outcomes (12)
In competitive employment or education at some point during follow up period
Measured: Measured at 18 month follow-up
Days to first employment or beginning of education
Measured: Measured at 18 month follow-up
Average monthly earnings in follow-up period
Measured: Measured at 18 month follow-up
Hours of work per week among those who obtain competitive employment during the follow-up period
Measured: Measured at 18 month follow-up
Negative symptoms measured with Schedule for assessment of negative symptoms in schizophrenia (SANS)
Measured: Measured at 18 month follow-up
Cognitive functions measured with The Brief Assessment of Cognition in Schizophrenia (BAC)
Measured: Measured at 18 month follow-up
Functioning measured with Global Assessment of Functioning (GAF)
Measured: Measured at 18 month follow-up
Functioning measured with Personal and Social Performance (PSP)
Measured: Measured at 18 month follow-up
Quality of life measured with SF-12
Measured: Measured at 18 month follow-up
Empowerment measured with Empowerment Scale
Measured: Measured at 18 month follow-up
Self-efficacy measured with General self-efficacy scale (GSE)
Measured: Measured at 18 month follow-up
Self-esteem measured with The Rosenberg Self-Esteem scale
Measured: Measured at 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia, Schizotypal and Delusional DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen Municipality, Denmark, Odense Municipality, Copenhagen Trial Unit, Center for Clinical Intervention Research, Silkeborg Municipality
- Responsible party
- Sponsor
- Investigators
- Lene F Eplov, MD, Phd, Study director, Copenhagen University Hospital, Mental Health Centre CopenhagenMerete Nordentoft, Professor, Principal investigator, Copenhagen University Hospital, Mental Health Centre CopenhagenElsebeth Stenager, MD, Phd, Principal investigator, Department of Psychiatry, Odense, The University of Southern Denmark.Bent Nielsen, Professor, Principal investigator, Department of Psychiatry, Odense, The University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722344
- Sponsor's protocol ID
- PCK-2012-CT-2912
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2012
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christensen TN, Wallstrom IG, Stenager E, Bojesen AB, Gluud C, Nordentoft M, Eplov LF. Effects of Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training for People With Severe Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Dec 1;76(12):1232-1240. doi: 10.1001/jamapsychiatry.2019.2291.
PubMed 31483451Christensen TN, Nielsen IG, Stenager E, Morthorst BR, Lindschou J, Nordentoft M, Eplov LF. Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:280. doi: 10.1186/s13063-015-0792-0.
PubMed 26093636
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Placement and Support (IPS) Enhanced With Cognitive Remediation and Social Skills Training in Denmark: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01722344
- Acronym / sponsor ID
- PCK-2012-CT-2912
- Conditions
- Schizophrenia, Schizotypal and Delusional Disorders, Bipolar Affective Disorder, Recurrent Depressive Disorder
- Keywords
- Severe mental illness, Vocational rehabilitation, Supported employment, Individual placement and support, Cognitive remediation, Social skill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen Municipality, Denmark, Odense Municipality, Copenhagen Trial Unit, Center for Clinical Intervention Research, Silkeborg Municipality
- Study start
- Oct 2012 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 6 Nov 2012 (estimated)
- 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.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Behavioral: Individual Placement and support (IPS) |
| IPS plus | Experimental | Behavioral: Individual Placement and support (IPS), Behavioral: IPS plusIndividual Placement and Support plus cognitive remediation and work-related social skills training |
| Standard intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
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 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 | Behavioural | IPS plus, Individual Placement and Support (IPS) |
| IPS plusIndividual 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. | Behavioural | IPS plus |
Primary outcome
Hours in competitive employment or education
Time frame: Measured at 18 month
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 31483451Christensen TN, Wallstrom IG, Stenager E, Bojesen AB, Gluud C, Nordentoft M, Eplov LF. Effects of Individual Placement and Support Supplemented With Cognitive Remediation and Work-Focused Social Skills Training for People With Severe Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Dec 1;76(12):1232-1240. doi: 10.1001/jamapsychiatry.2019.2291.
- Derived from this study: PubMed 26093636Christensen TN, Nielsen IG, Stenager E, Morthorst BR, Lindschou J, Nordentoft M, Eplov LF. Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:280. doi: 10.1186/s13063-015-0792-0.
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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.
Lene F Eplov, MD, Phd study director
Copenhagen University Hospital, Mental Health Centre Copenhagen
Merete Nordentoft, Professor principal investigator
Copenhagen University Hospital, Mental Health Centre Copenhagen
Elsebeth Stenager, MD, Phd principal investigator
Department of Psychiatry, Odense, The University of Southern Denmark.
1 site 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) and IPS plus in people with Schizophrenia, Schizotypal and Delusional Disorders and Bipolar Affective Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hours in competitive employment or education (time frame: Measured at 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722344, which also lists 2 linked publications.
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 15 Mar 2024.