NCT05866328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

September 11, 2019

Last Update Submit

June 1, 2023

Conditions

Social Cognition

Keywords

rehabilitationschizophreniaemotional adjustmenttheory of mind

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Employment

    Up to 12 months in 2021

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Cognitive Rehabilitation and Individual Placement and Support

Control

NO INTERVENTION

Control Group (Individual Placement and Support)

Interventions

Cognitive Rehabilitation and Individual Placement and SupportOTHER

Cognitive Rehabilitation and Individual Placement and Support

Also known as: CR and IPS
Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • People with no Severe mental illness and not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Rodriguez Pulido

San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38205, Spain

Location

Related Publications (3)

  • 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.

    PMID: 28740808RESULT

  • 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.

    PMID: 29535646RESULT

  • 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.

    PMID: 38025483DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive TrainingPalliative CareMyo-Inositol-1-Phosphate Synthase

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesIntramolecular LyasesIsomerasesEnzymesEnzymes and Coenzymes

Study Officials

  • Francisco Rodriguez Pulido, PHD MD

    University of La Laguna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Experimental: ET and IPS Control: IPS
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cognitive rehabilitation with a cognitive training program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 11, 2019

First Posted

May 19, 2023

Study Start

December 13, 2019

Primary Completion

October 18, 2021

Study Completion

January 10, 2022

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Publicate the results in a International Journal

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2019-2020
Access Criteria
International Journal

Locations

ES(1)