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

NCT ID: NCT05866328

Last Updated: 2023-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2022-01-10

Brief Summary

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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

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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

Conditions

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Social Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cognitive rehabilitation with a cognitive training program
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Experimental: ET and IPS Control: IPS

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Cognitive Rehabilitation and Individual Placement and Support

Intervention Type OTHER

Cognitive Rehabilitation and Individual Placement and Support

Control

Control Group (Individual Placement and Support)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Rehabilitation and Individual Placement and Support

Cognitive Rehabilitation and Individual Placement and Support

Intervention Type OTHER

Other Intervention Names

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CR and IPS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Santiago de Compostela

OTHER

Sponsor Role collaborator

University of La Laguna

OTHER

Sponsor Role lead

Responsible Party

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Francisco Pulido

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Rodriguez Pulido, PHD MD

Role: STUDY_DIRECTOR

University of La Laguna

Locations

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Francisco Rodriguez Pulido

San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 28740808 (View on PubMed)

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.

Reference Type RESULT
PMID: 29535646 (View on PubMed)

Rodriguez Pulido F, Caballero Estebaranz N, Garcia Caballero AA, Gonzalez Davila E, Leon Palacin C, Hernandez Alvarez de Sotomayor MDC, Lopez Reig S, Vilchez de Leon PI. Social cognition and emotional rehabilitation in participants with schizofrenia. Front Psychiatry. 2023 Nov 8;14:1250933. doi: 10.3389/fpsyt.2023.1250933. eCollection 2023.

Reference Type DERIVED
PMID: 38025483 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ULaguna

Identifier Type: -

Identifier Source: org_study_id

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