Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
- Conditions
- Social Cognition
- Interventions
- Other: Cognitive Rehabilitation and Individual Placement and Support
- Registration Number
- NCT05866328
- Lead Sponsor
- University of La Laguna
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
People with no Severe mental illness and not want to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Cognitive Rehabilitation and Individual Placement and Support Experimental Group (e-Motional Training and Individual Placement and Support)
- Primary Outcome Measures
Name Time Method 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.
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.
Movie for the Assessment of Social Cognition total score changes At baseline and after 1 year treatment Minimum 0 and maximum 42.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method Employment Up to 12 months in 2021 Number of jobs
Trial Locations
- Locations (1)
Francisco Rodriguez Pulido
🇪🇸La Laguna, Santa CRUZ DE Tenerife, Spain