- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865186
An Evaluation of a Psychoeducation Program in Individuals Diagnosed With Schizophrenia
An Evaluation of a Psychoeducation Program for Emotion Identification and Expression in Individuals Diagnosed With Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The difficulties those diagnosed with schizophrenia have with facial identification and identifying emotions are closely associated with the adverse symptoms of the illness. Those diagnosed with schizophrenia need to be helped in forming interpersonal relations so that they can gain the skills needed to live in society.
ın this study the investigators prepared a psychoeducation program for individuals diagnosed with schizophrenia. 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. On the other hand there were a control group which weren't be applied any intervention. The investigators applied some tests to intervention and control group three times ( before intervention, after intervention and three months after intervention). This study was conducted at three Community Mental Health Centers (CMHC's). The patients who met the study inclusion criterias were determined in these centers. Randomized psychoeducation and control groups were formed from these patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of schizophrenia according to DSM-IV
- over the age of 18
Exclusion Criteria:
- having cominication problems
- having another psychiatric disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
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.
|
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.
|
Experimental: control group
no intervention was applied to the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial Emotion Identification
Time Frame: 15 minutes
|
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
Time Frame: 20 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal and Social Performance
Time Frame: 20 minutes
|
Personal and Social Performance Test (PSP) This is a 6-item Likert-type ranked assessment of four dimensions.The patient is first evaluated on the basis of the four dimensions and then the scores in these areas are entered into the score sheet on the basis of 10-point ranges from 10-100 according to the PSP assessment guidelines, assigning the patient a total PSP score.
The higher scores indicate better functionality
|
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gül Ünsal, PhD, Marmara University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAsik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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