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

Primary Purpose

Social Cognition

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive Rehabilitation and Individual Placement and Support
Sponsored by
University of La Laguna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Social Cognition focused on measuring rehabilitation, schizophrenia, emotional adjustment, theory of mind

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants had to: 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) have previous difficulties to maintain a job currently want a competitive job and accept the job search starts Exclusion Criteria: People with no Severe mental illness and not want to participate

Sites / Locations

  • Francisco Rodriguez Pulido

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Experimental Group (e-Motional Training and Individual Placement and Support)

Control Group (Individual Placement and Support)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Movie for the Assessment of Social Cognition total score changes
Minimum 0 and maximum 42.
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.
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.

Secondary Outcome Measures

Employment
Number of jobs

Full Information

First Posted
September 11, 2019
Last Updated
June 1, 2023
Sponsor
University of La Laguna
Collaborators
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT05866328
Brief Title
Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
Acronym
TP;SC
Official Title
Online Training Program on Social Cognition for Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of La Laguna
Collaborators
University of Santiago de Compostela

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Cognition
Keywords
rehabilitation, schizophrenia, emotional adjustment, theory of mind

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cognitive rehabilitation with a cognitive training program
Masking
Care ProviderOutcomes Assessor
Masking Description
Experimental: ET and IPS Control: IPS
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Experimental Group (e-Motional Training and Individual Placement and Support)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group (Individual Placement and Support)
Intervention Type
Other
Intervention Name(s)
Cognitive Rehabilitation and Individual Placement and Support
Other Intervention Name(s)
CR and IPS
Intervention Description
Cognitive Rehabilitation and Individual Placement and Support
Primary Outcome Measure Information:
Title
Ekman 60 Faces Test total score changes
Description
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.
Time Frame
At baseline and after 1 year treatment
Title
Hinting Task total score changes
Description
Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit.
Time Frame
At baseline and after 1 year treatment
Title
Happé Strange Stories Test total score changes
Description
Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit.
Time Frame
At baseline and after 1 year treatment
Title
Faux Pas Recognition Test total score changes
Description
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.
Time Frame
At baseline and after 1 year treatment
Title
Ambiguous Intentions and Hostility Questionnaire total score changes
Description
Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean.
Time Frame
At baseline and after 1 year treatment
Title
Movie for the Assessment of Social Cognition total score changes
Description
Minimum 0 and maximum 42.
Time Frame
At baseline and after 1 year treatment
Title
Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes
Description
Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale.
Time Frame
At baseline and after 1 year treatment
Title
Positive and Negative Symptom Scale (PANSS) total score changes
Description
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.
Time Frame
At baseline and after 1 year treatment
Secondary Outcome Measure Information:
Title
Employment
Description
Number of jobs
Time Frame
Up to 12 months in 2021

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants had to: 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) have previous difficulties to maintain a job currently want a competitive job and accept the job search starts Exclusion Criteria: People with no Severe mental illness and not want to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Rodriguez Pulido, PHD MD
Organizational Affiliation
University of La Laguna
Official's Role
Study Director
Facility Information:
Facility Name
Francisco Rodriguez Pulido
City
La Laguna
State/Province
Santa CRUZ DE Tenerife
ZIP/Postal Code
38205
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publicate the results in a International Journal
IPD Sharing Time Frame
2019-2020
IPD Sharing Access Criteria
International Journal
Citations:
PubMed Identifier
28740808
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.2015.11.007. eCollection 2016 Jun.
Results Reference
result
PubMed Identifier
29535646
Citation
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.
Results Reference
result

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

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