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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02399020
Other study ID # 169/13/03/03/2011
Secondary ID
Status Completed
Phase N/A
First received March 23, 2015
Last updated March 23, 2015
Start date January 2011
Est. completion date May 2013

Study information

Verified date March 2015
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- inadequate command of Finnish language

- unstable clinical condition

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Social Cognition and Interaction Training
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.

Locations

Country Name City State
Finland Aurora Hospital Helsinki

Sponsors (3)

Lead Sponsor Collaborator
Helsinki University Central Hospital City of Helsinki, The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Combs 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. — View Citation

Corcoran 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. — View Citation

Kerr 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. — View Citation

Penn 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary improvement in social cognitive ability improvement according to measures of facial emotion recognition, theory of mind, attributional bias and social cognitive accuracy. 11-24 weeks No
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