Online TP (Training Program) on SC (Social Cognition) for Schizophrenia

Social Cognition Clinical Trial

— TP;SC  

Official title:

Online Training Program on Social Cognition for Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05866328
• Other study ID #: ULaguna
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: January 10, 2022

Study information

• Verified date: June 2023
• Source: University of La Laguna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. Fifty-seven met criteria and agreed to participate in the study. The conditions of cognitive rehabilitation were assigned randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program was used. Two groups were followed at 8 and 12 months after the baseline.

Description:

This work was developed in the island of Tenerife (Spain) within a public service specialised in labour integration of people with disabilities in which an IPS team was set up in 2005. The study was carried out in collaboration with the units of community mental health of the island. These units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. All research procedures were approved by the Medicine Committee of Canary Health Services.

The follow-up period for the data collection was set between 2013 and 2014. Employment specialists belong to a public institution specialized in work disability.Sixty-five participants but only 57 signed written informed consent and completed the baseline. Two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with IPS alone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 10, 2022
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Participants had to:

1. comply with the state definitions of severe mental illness (SMI), which includes an ICD-10 (World Health Organization, 1992) diagnosis of F20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and F31-F32.3 (major mood affective disorders)

2. have previous difficulties to maintain a job

3. currently want a competitive job and

4. accept the job search starts

Exclusion Criteria:

People with no Severe mental illness and not want to participate

Related Conditions & MeSH terms

• Schizophrenia
• Social Cognition

Intervention

Other:
• Cognitive Rehabilitation and Individual Placement and Support
Cognitive Rehabilitation and Individual Placement and Support

Locations

Country	Name	City	State
Spain	Francisco Rodriguez Pulido	La Laguna	Santa CRUZ DE Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
University of La Laguna	University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Marono Souto Y, Vazquez Campo M, Diaz Llenderrozas F, Rodriguez Alvarez M, Mateos R, Garcia Caballero A. Randomized Clinical Trial with e-MotionalTraining(R) 1.0 for Social Cognition Rehabilitation in Schizophrenia. Front Psychiatry. 2018 Feb 26;9:40. doi — View Citation

Vazquez-Campo M, Marono Y, Lahera G, Mateos R, Garcia-Caballero A. e-Motional Training(R): Pilot study on a novel online training program on social cognition for patients with schizophrenia. Schizophr Res Cogn. 2016 Mar 12;4:10-17. doi: 10.1016/j.scog.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ekman 60 Faces Test total score changes	Minimum 0 and maximum 60. Between 20-40 years average 51.43, cut-off point 45, below deficit. Between 40-60 years, average 51.20, cut-off point 43, below deficit.	At baseline and after 1 year treatment
Primary	Hinting Task total score changes	Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit.	At baseline and after 1 year treatment
Primary	Happé Strange Stories Test total score changes	Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit.	At baseline and after 1 year treatment
Primary	Faux Pas Recognition Test total score changes	FP stories and C questions, C stories and FP questions and C stories and C questions minimum 0 and maximum 20. FP stories and FP questions minimum 0 and maximum 60. Cut-off point without errors 54 and with errors 48, lower deficit scores.	At baseline and after 1 year treatment
Primary	Ambiguous Intentions and Hostility Questionnaire total score changes	Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean.	At baseline and after 1 year treatment
Primary	Movie for the Assessment of Social Cognition total score changes	Minimum 0 and maximum 42.	At baseline and after 1 year treatment
Primary	Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes	Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale.	At baseline and after 1 year treatment
Primary	Positive and Negative Symptom Scale (PANSS) total score changes	Positive and negative subscales minimum 7 and maximum 49. General psychopathology subscale minimum 16 and maximum 112. Composite subscale minimum -42 and maximum +42. Categorize subtype positive >0 and negative <0.	At baseline and after 1 year treatment
Secondary	Employment	Number of jobs	Up to 12 months in 2021