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SchizophreniaNCT03865186

An Evaluation of a Psychoeducation Program in Individuals Diagnosed With Schizophrenia

A study testing Psychoeducation Program in people with Schizophrenia, run by Kırıkkale University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Psychoeducation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 15 Jul 2016
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • having cominication problems
  • having another psychiatric disease

About this study

Official title: An Evaluation of a Psychoeducation Program for Emotion Identification and Expression in Individuals Diagnosed With Schizophrenia

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.

Read the 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.

Conditions
Schizophrenia
Being tested
Psychoeducation Program, no intervention
Keywords
Cognition, facial expression, facial recognition, psychiatric nursing, psychoeducation, schizophrenia
Medical subject headings
Schizophrenia, Facial Expression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducation ProgramBehavioural

    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.

  • no interventionBehavioural

Study groups in NCT03865186
Study groupRoleWhat they receive
intervention groupExperimentalThe 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.
Receives: Behavioral: Psychoeducation Program
control groupExperimentalno intervention was applied to the control group
Receives: Behavioral: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 15 minutes

  2. 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

    Measured: 20 minutes

Secondary outcomes (1)

  1. Personal and Social Performance

    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

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start1 Jan 2015
  3. Primary completion30 Oct 2015
  4. Study completion15 Jul 2016

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study was of quasi-experimental (pretest-posttest, with a control group) design.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03865186
Sponsor's protocol ID
EAsik
Status last verified
Mar 2019
First submitted
26 Feb 2019
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: this study manuscript sended to an academic journal

Publications

  • 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.

    PubMed 25533595

  • 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.

    PubMed 26977127

  • 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.

    PubMed 26598473

  • 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.

    PubMed 18562345

  • 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.

    PubMed 20570490

  • 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.

    PubMed 18585899

  • 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.

    PubMed 25248938

  • 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.

    PubMed 27445866

  • 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.

    PubMed 26607670

  • 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.

    PubMed 22695257

  • 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.

    PubMed 28099444

  • 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.

    PubMed 8315144

  • 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.

    PubMed 23245340

  • 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.

    PubMed 23125396

  • 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.

    PubMed 22959743

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducation Program in people with Schizophrenia, run by Kırıkkale University.

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 2 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Facial Emotion Identification (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 NCT03865186, which also lists 17 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 6 Mar 2019.

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