Skip to main content
OpenTrials
Completed

NCT Number: NCT05866328

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Social Cognition Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francisco Rodriguez Pulido

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Rehabilitation and Individual Placement and Support

Other

Cognitive Rehabilitation and Individual Placement and Support

Other names: CR and IPS

Primary outcomes

  1. Ekman 60 Faces Test total score changes

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: At baseline and after 1 year treatment

    Minimum 0 and maximum 42.

  7. Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes

    Time frame: 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

    Time frame: 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 outcomes

  1. Employment

    Time frame: Up to 12 months in 2021

    Number of jobs

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Collaborators

  • University of Santiago de Compostela

Registry information

Official study title

Online Training Program on Social Cognition for Patients With Schizophrenia

Acronym: TP;SC

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 19, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.