Clinical trial NCT05866328: Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
Official title: Online Training Program on Social Cognition for Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Cognition
Keywords: rehabilitation
schizophrenia
emotional adjustment
theory of mind
Lead sponsor: University of La Laguna
Sponsor class: OTHER
Collaborators: name: University of Santiago de Compostela
First posted: 2023-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cognitive rehabilitation with a cognitive training program
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Ekman 60 Faces Test total score changes
timeFrame: At baseline and after 1 year treatment
measure: Hinting Task total score changes
timeFrame: At baseline and after 1 year treatment
measure: Happé Strange Stories Test total score changes
timeFrame: At baseline and after 1 year treatment
measure: Faux Pas Recognition Test total score changes
timeFrame: At baseline and after 1 year treatment
measure: Ambiguous Intentions and Hostility Questionnaire total score changes
timeFrame: At baseline and after 1 year treatment
measure: Movie for the Assessment of Social Cognition total score changes
timeFrame: At baseline and after 1 year treatment
measure: Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes
timeFrame: At baseline and after 1 year treatment
measure: Positive and Negative Symptom Scale (PANSS) total score changes
timeFrame: At baseline and after 1 year treatment
Secondary outcomes:
measure: Employment
timeFrame: Up to 12 months in 2021
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Francisco Rodriguez Pulido
state: Santa CRUZ DE Tenerife
Study officials:
affiliation: University of La Laguna
name: Francisco Rodriguez Pulido, PHD MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.