Psychotic DisorderNCT02399020
Social Cognition and Interaction Training for Adults With Psychotic Disorders: An Open Pilot Study in Finland
A study testing Social Cognition and Interaction Training in people with Psychotic Disorder and Cognitive Function 1, Social, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorder, Cognitive Function 1, Social
- What is being tested?
- Social Cognition and Interaction Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of schizophrenia, schizoaffective disorder or psychosis NOS
- inpatients in longer-stay rehabilitation wards or outpatients in supported housing
- stable clinical condition
- written informed consent
- problems in social relationships according to the clinical staff
- standard medical treatment provided by the care facilities
Who cannot join
- inadequate command of Finnish language
- unstable clinical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Cognition and Interaction Training (SCIT) for Adults With Psychotic Disorder: An Open Pilot Study in Finland
33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the intervention. Main outcome was improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.
Read the detailed description
33 clinically stable in- and outpatients with chart diagnoses of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis, aged 18-56 years, were given 22-24 weekly or twice weekly sessions of a manualized group treatment for improvement of social cognition, Social Cognition and Interaction Training (1,2). Main outcome was defined as improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.Emotion perception was measured with the Facial Emotion Identification Task (FEIT) (3); Theory of Mind was measured with the Hinting Task (4) and attributional bias with the Ambiguous Intentions Hostility Questionnaire-Ambiguous Items (AIHQ-A) (5). In addition, broad-based social cognitive accuracy, attributional bias and metacognitive overconfidence was measured with the Social Cognition Screening Questionnaire. All the measures were evaluated at the baseline and immediately after the intervention. Changes in total scores for the FEIT and Hinting Task, and the three subscales of AIHQ-A and SCSQ were analysed separately using paired samples t-test in IBM SPSS Statistics version 21.
- Conditions
- Psychotic Disorder, Cognitive Function 1, Social
- Being tested
- Social Cognition and Interaction Training
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition and Interaction TrainingBehavioural
manualized group treatment providing training in facial emotion recognition, understanding the role of emotion in social situations, training with videoed vignettes to avoid jumping to conclusions in order to avoid attributional biases, tolerating ambiguity and distinguishing facts from guesses, skill consolidation and generalization to everyday life situations.
| Study group | Role | What they receive |
|---|---|---|
| SCIT group | Experimental | Social Cognition and Interaction Training intervention group Receives: Behavioral: Social Cognition and Interaction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in social cognitive ability
improvement according to measures of facial emotion recognition, theory of mind, attributional bias and social cognitive accuracy.
Measured: 11-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, City of Helsinki
- Responsible party
- Principal investigator, Jorma Oksanen MD, Helsinki University Central Hospital
- Investigators
- Leena Turpeinen, MD, Study director, City of Helsinki Department of Social Services and Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399020
- Sponsor's protocol ID
- 169/13/03/03/2011
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberts DL, Penn DL. Social cognition and interaction training (SCIT) for outpatients with schizophrenia: a preliminary study. Psychiatry Res. 2009 Apr 30;166(2-3):141-7. doi: 10.1016/j.psychres.2008.02.007. Epub 2009 Mar 9.
PubMed 19272654Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.
PubMed 17412842Kerr SL, Neale JM. Emotion perception in schizophrenia: specific deficit or further evidence of generalized poor performance? J Abnorm Psychol. 1993 May;102(2):312-8. doi: 10.1037//0021-843x.102.2.312.
PubMed 8315144Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.
PubMed 8541250Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.
PubMed 17453895
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Interaction Training (SCIT) for Adults With Psychotic Disorder: An Open Pilot Study in Finland
- ClinicalTrials.gov ID
- NCT02399020
- Acronym / sponsor ID
- 169/13/03/03/2011
- Conditions
- Psychotic Disorder, Cognitive Function 1, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, City of Helsinki
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Mar 2015 (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.
33 individuals with a psychotic disorder were given 22-24 sessions weekly or twice weekly of Social Cognition and Interaction Training (SCIT) and evaluated at the baseline and after the intervention. Main outcome was improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.
Detailed description
33 clinically stable in- and outpatients with chart diagnoses of schizophrenia, schizoaffective disorder or unspecified nonorganic psychosis, aged 18-56 years, were given 22-24 weekly or twice weekly sessions of a manualized group treatment for improvement of social cognition, Social Cognition and Interaction Training (1,2). Main outcome was defined as improvement in social cognition according to specific measures of facial emotion identification, Theory of Mind, attributional bias, social cognitive accuracy and metacognitive overconfidence.Emotion perception was measured with the Facial Emotion Identification Task (FEIT) (3); Theory of Mind was measured with the Hinting Task (4) and attributional bias with the Ambiguous Intentions Hostility Questionnaire-Ambiguous Items (AIHQ-A) (5). In addition, broad-based social cognitive accuracy, attributional bias and metacognitive overconfidence was measured with the Social Cognition Screening Questionnaire. All the measures were evaluated at the baseline and immediately after the intervention. Changes in total scores for the FEIT and Hinting Task, and the three subscales of AIHQ-A and SCSQ were analysed separately using paired samples t-test in IBM SPSS Statistics version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCIT group | Experimental | Behavioral: Social Cognition and Interaction TrainingSocial Cognition and Interaction Training intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinical diagnosis of schizophrenia, schizoaffective disorder or psychosis NOS
- inpatients in longer-stay rehabilitation wards or outpatients in supported housing
- stable clinical condition
- written informed consent
- problems in social relationships according to the clinical staff
Key exclusion criteria (2 listed)
- inadequate command of Finnish language
- unstable clinical condition
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 |
|---|---|---|
| Social Cognition and Interaction Trainingmanualized group treatment providing training in facial emotion recognition, understanding the role of emotion in social situations, training with videoed vignettes to avoid jumping to conclusions in order to avoid attributional biases, tolerating ambiguity and distinguishing facts from guesses, skill consolidation and generalization to everyday life situations. | Behavioural | SCIT group |
Primary outcome
improvement in social cognitive ability
Time frame: 11-24 weeks
improvement according to measures of facial emotion recognition, theory of mind, attributional bias and social cognitive accuracy.
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 26 Mar 2015.
- Background: PubMed 19272654Roberts DL, Penn DL. Social cognition and interaction training (SCIT) for outpatients with schizophrenia: a preliminary study. Psychiatry Res. 2009 Apr 30;166(2-3):141-7. doi: 10.1016/j.psychres.2008.02.007. Epub 2009 Mar 9.
- Background: PubMed 17412842Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.
- Background: PubMed 8315144Kerr SL, Neale JM. Emotion perception in schizophrenia: specific deficit or further evidence of generalized poor performance? J Abnorm Psychol. 1993 May;102(2):312-8. doi: 10.1037//0021-843x.102.2.312.
- Background: PubMed 8541250Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.
- Background: PubMed 17453895Combs DR, Penn DL, Wicher M, Waldheter E. The Ambiguous Intentions Hostility Questionnaire (AIHQ): a new measure for evaluating hostile social-cognitive biases in paranoia. Cogn Neuropsychiatry. 2007 Mar;12(2):128-43. doi: 10.1080/13546800600787854.
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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.
Leena Turpeinen, MD study director
City of Helsinki Department of Social Services and Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition and Interaction Training in people with Psychotic Disorder and Cognitive Function 1, Social, run by Helsinki University Central Hospital at 1 site in Finland.
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 6 inclusion and 2 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 26 Mar 2015. 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 Finland. 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?
improvement in social cognitive ability (time frame: 11-24 weeks). 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 NCT02399020, which also lists 5 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 26 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.