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

Online Training Program on Social Cognition for Patients With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Social Cognition
• Intervention / Treatment: Other: Cognitive Rehabilitation and Individual Placement and Support

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa CRUZ DE Tenerife
    • La Laguna, Santa CRUZ DE Tenerife, Spain, 38205
      • Francisco Rodriguez Pulido

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Experimental Group (e-Motional Training and Individual Placement and Support)	Other: Cognitive Rehabilitation and Individual Placement and Support; Cognitive Rehabilitation and Individual Placement and Support; Other Names: CR and IPS
No Intervention: Control; Control Group (Individual Placement and Support)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Movie for the Assessment of Social Cognition total score changes	Minimum 0 and maximum 42.	At baseline and after 1 year treatment
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment	Number of jobs	Up to 12 months in 2021

Collaborators and Investigators

• Sponsor: University of La Laguna
• Collaborators: University of Santiago de Compostela
• Investigators: Study Director: Francisco Rodriguez Pulido, PHD MD, University of La Laguna

Publications and helpful links

General Publications

• 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.2015.11.007. eCollection 2016 Jun.
• 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: 10.3389/fpsyt.2018.00040. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): October 18, 2021
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; schizophrenia; theory of mind; emotional adjustment
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: ULaguna

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publicate the results in a International Journal
• IPD Sharing Time Frame: 2019-2020
• IPD Sharing Access Criteria: International Journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No