SchizophreniaNCT01206842
Social Cognition Training in Schizophrenia
A study testing Training in Affect Recognition in people with Schizophrenia and Social Cognition, run by Oslo University Hospital at 1 site in Norway.
Trial summary
People with schizophrenia show deficits in social cognition, the ability to process information about other people such as identifying their emotional expressions. Social cognition is associated with everyday life functioning and could therefore be an important treatment target. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Social Cognition
- What is being tested?
- Training in Affect Recognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2011to 1 May 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-55
- diagnosis of schizophrenia or schizoaffective disorder
- IQ > 69
- sufficient mastery of Norwegian to undergo assessments
Who cannot join
- history of head trauma
- neurological/medical condition known to interfere with central nervous system
- receiving outpatient care at time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
People with schizophrenia show deficits in social cognition, the ability to process information about other people such as identifying their emotional expressions. Social cognition is associated with everyday life functioning and could therefore be an important treatment target. Several social cognitive training programs have been developed during the last years. Results indicate that social cognitive performance can be ameliorated through commonly used intervention techniques. However, it is less clear whether this improvement generalizes to everyday life. The purpose of this study is to investigate if a social cognitive training program (Training in Affect Recognition) improves performance on social cognitive and neuropsychological tests and leads to improved everyday life functioning in persons with schizophrenia. The study also aims at examining if an improvement is present three months after completion of the training intervention.
- Conditions
- Schizophrenia, Social Cognition
- Being tested
- Training in Affect Recognition
- Keywords
- functional capacity, training, neurocognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in Affect RecognitionOther
A 12-session social cognitive training programming covering emotion perception and social perception administered in a group setting to up to four participants with schizophrenia at the time
| Study group | Role | What they receive |
|---|---|---|
| social cognition training | Experimental | Not described Receives: Other: Training in Affect Recognition |
| treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognitive tests
PFA and MASC
Measured: Within one week and within three months of completed training
Secondary outcomes (2)
Functional capacity tests
AIPSS and UPSA-brief
Measured: Within one week and within three months of completed training
Neuropsychological tests
MATRICS
Measured: Within one week and within three months of completed training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startAug 2011
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Vaskinn, Oslo University Hospital
- Investigators
- Anja Vaskinn, PhD, Principal investigator, Oslo University Hospital, Psychosis Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206842
- Sponsor's protocol ID
- 2010/1538 (REK)
- Status last verified
- May 2018
- First submitted
- 10 Sep 2010
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition Training in Schizophrenia
- ClinicalTrials.gov ID
- NCT01206842
- Acronym / sponsor ID
- 2010/1538 (REK)
- Conditions
- Schizophrenia, Social Cognition
- Keywords
- functional capacity, training, neurocognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 22 Sep 2010 (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.
People with schizophrenia show deficits in social cognition, the ability to process information about other people such as identifying their emotional expressions. Social cognition is associated with everyday life functioning and could therefore be an important treatment target. Several social cognitive training programs have been developed during the last years. Results indicate that social cognitive performance can be ameliorated through commonly used intervention techniques. However, it is less clear whether this improvement generalizes to everyday life. The purpose of this study is to investigate if a social cognitive training program (Training in Affect Recognition) improves performance on social cognitive and neuropsychological tests and leads to improved everyday life functioning in persons with schizophrenia. The study also aims at examining if an improvement is present three months after completion of the training intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| social cognition training | Experimental | Other: Training in Affect Recognition |
| treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-55
- diagnosis of schizophrenia or schizoaffective disorder
- IQ > 69
- sufficient mastery of Norwegian to undergo assessments
Key exclusion criteria (3 listed)
- history of head trauma
- neurological/medical condition known to interfere with central nervous system
- receiving outpatient care at time of recruitment
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 |
|---|---|---|
| Training in Affect RecognitionA 12-session social cognitive training programming covering emotion perception and social perception administered in a group setting to up to four participants with schizophrenia at the time | Other | social cognition training |
Primary outcome
Social cognitive tests
Time frame: Within one week and within three months of completed training
PFA and MASC
2 secondary outcomes
Functional capacity tests
Time frame: Within one week and within three months of completed training
Neuropsychological tests
Time frame: Within one week and within three months of completed training
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 22 May 2018.
Related trials for Schizophrenia
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Anja Vaskinn, PhD principal investigator
Oslo University Hospital, Psychosis Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in Affect Recognition in people with Schizophrenia and Social Cognition, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 3 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 22 May 2018. 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 Norway. 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?
Social cognitive tests (time frame: Within one week and within three months of completed training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2018.