NCT03865186

Brief Summary

This study was conducted to explore the effect on social functionality of the psychoeducation program organized to guide individuals diagnosed with schizophrenia to identifying and recognize emotions in facial expressions. half of participants were assessed the psychoeducation program. other half of participants were used only measurement tests.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

February 26, 2019

Last Update Submit

March 5, 2019

Conditions

Keywords

Cognitionfacial expressionfacial recognitionpsychiatric nursingpsychoeducationschizophrenia

Outcome Measures

Primary Outcomes (2)

  • Facial Emotion Identification

    Facial Emotion Identification Test (FEIT) The test is in the form of a slide presentation of 19 black-and-white facial photographs displaying expressions of different emotions. Correct answers are rated 1, errors are scored 0. The highest possible score on the test is 19

    15 minutes

  • Facial Emotion Discrimination

    Facial Emotion Discrimination Test (FEDT) This consists of 30 pairs of black-and-white photographs depicting six main emotional states (happiness, sadness, anger, fear, surprise, embarrassment). The participant is asked to differentiate the photographs in each pair, determining whether the two facial expressions are the same or different. If the answer is correct, it is scored 1; if wrong, the score is 0. The highest possible score on the test is 30

    20 minutes

Secondary Outcomes (1)

  • Personal and Social Performance

    20 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

The program titled, "Psychoeducation Program for Emotion Identification and Expression in Those Diagnosed with Schizophrenia" was conducted with the patients in the intervention groups once a week for ten weeks.

Behavioral: Psychoeducation Program

control group

EXPERIMENTAL

no intervention was applied to the control group

Behavioral: no intervention

Interventions

The program titled, "Psychoeducation Program for Emotion Identification and Expression in Those Diagnosed with Schizophrenia" was conducted with the patients in the intervention groups once a week for ten weeks.

intervention group
no interventionBEHAVIORAL
control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of schizophrenia according to DSM-IV
  • over the age of 18

You may not qualify if:

  • having cominication problems
  • having another psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Allott KA, Rice S, Bartholomeusz CF, Klier C, Schlogelhofer M, Schafer MR, Amminger GP. Emotion recognition in unaffected first-degree relatives of individuals with first-episode schizophrenia. Schizophr Res. 2015 Feb;161(2-3):322-8. doi: 10.1016/j.schres.2014.12.010. Epub 2014 Dec 19.

    PMID: 25533595BACKGROUND
  • Byrne LK, Pan L, McCABE M, Mellor D, Xu Y. Assessment of a six-week computer-based remediation program for social cognition in chronic schizophrenia. Shanghai Arch Psychiatry. 2015 Oct;27(5):296-306. doi: 10.11919/j.issn.1002-0829.215095.

    PMID: 26977127BACKGROUND
  • Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.

    PMID: 26598473BACKGROUND
  • Cohen AS, Minor KS. Emotional experience in patients with schizophrenia revisited: meta-analysis of laboratory studies. Schizophr Bull. 2010 Jan;36(1):143-50. doi: 10.1093/schbul/sbn061. Epub 2008 Jun 17.

    PMID: 18562345BACKGROUND
  • Combs DR, Chapman D, Waguspack J, Basso MR, Penn DL. Attention shaping as a means to improve emotion perception deficits in outpatients with schizophrenia and impaired controls. Schizophr Res. 2011 Apr;127(1-3):151-6. doi: 10.1016/j.schres.2010.05.011. Epub 2010 Jun 8.

    PMID: 20570490BACKGROUND
  • Combs DR, Tosheva A, Penn DL, Basso MR, Wanner JL, Laib K. Attentional-shaping as a means to improve emotion perception deficits in schizophrenia. Schizophr Res. 2008 Oct;105(1-3):68-77. doi: 10.1016/j.schres.2008.05.018. Epub 2008 Jun 27.

    PMID: 18585899BACKGROUND
  • Drusch K, Stroth S, Kamp D, Frommann N, Wolwer W. Effects of Training of Affect Recognition on the recognition and visual exploration of emotional faces in schizophrenia. Schizophr Res. 2014 Nov;159(2-3):485-90. doi: 10.1016/j.schres.2014.09.003. Epub 2014 Sep 20.

    PMID: 25248938BACKGROUND
  • Gaudelus B, Virgile J, Geliot S; GAIA/RECOS Study Team; Franck N. Improving Facial Emotion Recognition in Schizophrenia: a Controlled Study Comparing Specific and Attentional Focused Cognitive Remediation. Front Psychiatry. 2016 Jun 21;7:105. doi: 10.3389/fpsyt.2016.00105. eCollection 2016.

    PMID: 27445866BACKGROUND
  • Gur RC, Gur RE. Social cognition as an RDoC domain. Am J Med Genet B Neuropsychiatr Genet. 2016 Jan;171B(1):132-41. doi: 10.1002/ajmg.b.32394. Epub 2015 Nov 26.

    PMID: 26607670BACKGROUND
  • Hooker CI, Bruce L, Fisher M, Verosky SC, Miyakawa A, Vinogradov S. Neural activity during emotion recognition after combined cognitive plus social cognitive training in schizophrenia. Schizophr Res. 2012 Aug;139(1-3):53-9. doi: 10.1016/j.schres.2012.05.009. Epub 2012 Jun 12.

    PMID: 22695257BACKGROUND
  • Huang CL, Hsiao S. The Functional Significance of Affect Recognition, Neurocognition, and Clinical Symptoms in Schizophrenia. PLoS One. 2017 Jan 18;12(1):e0170114. doi: 10.1371/journal.pone.0170114. eCollection 2017.

    PMID: 28099444BACKGROUND
  • 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. doi: 10.1037//0021-843x.102.2.312.

    PMID: 8315144BACKGROUND
  • Kring AM, Elis O. Emotion deficits in people with schizophrenia. Annu Rev Clin Psychol. 2013;9:409-33. doi: 10.1146/annurev-clinpsy-050212-185538. Epub 2012 Dec 10.

    PMID: 23245340BACKGROUND
  • Lindenmayer JP, McGurk SR, Khan A, Kaushik S, Thanju A, Hoffman L, Valdez G, Wance D, Herrmann E. Improving social cognition in schizophrenia: a pilot intervention combining computerized social cognition training with cognitive remediation. Schizophr Bull. 2013 May;39(3):507-17. doi: 10.1093/schbul/sbs120. Epub 2012 Nov 3.

    PMID: 23125396BACKGROUND
  • Marsh PJ, Luckett G, Russell T, Coltheart M, Green MJ. Effects of facial emotion recognition remediation on visual scanning of novel face stimuli. Schizophr Res. 2012 Nov;141(2-3):234-40. doi: 10.1016/j.schres.2012.08.006. Epub 2012 Sep 5.

    PMID: 22959743BACKGROUND
  • Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand. 2000 Apr;101(4):323-9.

    PMID: 10782554BACKGROUND
  • Rose A, Vinogradov S, Fisher M, Green MF, Ventura J, Hooker C, Merzenich M, Nahum M. Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol. BMC Psychiatry. 2015 Jul 3;15:142. doi: 10.1186/s12888-015-0510-1.

    PMID: 26138715BACKGROUND

MeSH Terms

Conditions

SchizophreniaFacial Expression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNonverbal CommunicationCommunicationBehavior

Study Officials

  • Gül Ünsal, PhD

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was of quasi-experimental (pretest-posttest, with a control group) design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 6, 2019

Study Start

January 1, 2015

Primary Completion

October 30, 2015

Study Completion

July 15, 2016

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

this study manuscript sended to an academic journal