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

Sponsor
University of La Laguna (Other)
Overall Status
Completed
CT.gov ID
NCT05866328
Collaborator
University of Santiago de Compostela (Other)
50
Enrollment
1
Location
2
Arms
24.9
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Rehabilitation and Individual Placement and Support
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cognitive rehabilitation with a cognitive training programCognitive rehabilitation with a cognitive training program
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
Experimental: ET and IPS Control: IPS
Primary Purpose:
Health Services Research
Official Title:
Online Training Program on Social Cognition for Patients With Schizophrenia
Actual Study Start Date :
Dec 13, 2019
Actual Primary Completion Date :
Oct 18, 2021
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Ekman 60 Faces Test total score changes [At baseline and after 1 year treatment]

      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.

    2. Hinting Task total score changes [At baseline and after 1 year treatment]

      Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit.

    3. Happé Strange Stories Test total score changes [At baseline and after 1 year treatment]

      Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit.

    4. Faux Pas Recognition Test total score changes [At baseline and after 1 year treatment]

      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.

    5. Ambiguous Intentions and Hostility Questionnaire total score changes [At baseline and after 1 year treatment]

      Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean.

    6. Movie for the Assessment of Social Cognition total score changes [At baseline and after 1 year treatment]

      Minimum 0 and maximum 42.

    7. Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes [At baseline and after 1 year treatment]

      Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale.

    8. Positive and Negative Symptom Scale (PANSS) total score changes [At baseline and after 1 year treatment]

      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

    1. Employment [Up to 12 months in 2021]

      Number of jobs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Francisco Rodriguez Pulido La Laguna Santa CRUZ DE Tenerife Spain 38205

    Sponsors and Collaborators

    • University of La Laguna
    • University of Santiago de Compostela

    Investigators

    • Study Director: Francisco Rodriguez Pulido, PHD MD, University of La Laguna

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Francisco Pulido, Professor of Psychiatry, University of La Laguna
    ClinicalTrials.gov Identifier:
    NCT05866328
    Other Study ID Numbers:
    • ULaguna
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Francisco Pulido, Professor of Psychiatry, University of La Laguna
    rehabilitation
    schizophrenia
    emotional adjustment
    theory of mind
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of May 19, 2023