Social CognitionTP;SCNCT05866328
Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
A study testing Cognitive Rehabilitation and Individual Placement and Support in people with Social Cognition, run by University of La Laguna at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Cognition
- What is being tested?
- Cognitive Rehabilitation and Individual Placement and Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2019to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People with no Severe mental illness and not want to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site
Francisco Rodriguez Pulido
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38205
About this study
Official title: Online Training Program on Social Cognition for Patients With 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.
Read the 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
- Conditions
- Social Cognition
- Being tested
- Cognitive Rehabilitation and Individual Placement and Support
- Keywords
- rehabilitation, schizophrenia, emotional adjustment, theory of mind
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Rehabilitation and Individual Placement and SupportOther
Also called CR and IPS
Cognitive Rehabilitation and Individual Placement and Support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Experimental Group (e-Motional Training and Individual Placement and Support) Receives: Other: Cognitive Rehabilitation and Individual Placement and Support |
| Control | No intervention | Control Group (Individual Placement and Support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and after 1 year treatment
Movie for the Assessment of Social Cognition total score changes
Minimum 0 and maximum 42.
Measured: 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.
Measured: 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.
Measured: At baseline and after 1 year treatment
Secondary outcomes (1)
Employment
Number of jobs
Measured: Up to 12 months in 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start13 Dec 2019
- Primary completion18 Oct 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cognitive rehabilitation with a cognitive training program
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santiago de Compostela
- Responsible party
- Principal investigator, Francisco Pulido, University of La Laguna
- Investigators
- Francisco Rodriguez Pulido, PHD MD, Study director, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866328
- Sponsor's protocol ID
- ULaguna
- Acronym
- TP;SC
- Status last verified
- Jun 2023
- First submitted
- 11 Sep 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publicate the results in a International Journal
Publications
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.
PubMed 28740808Marono 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.
PubMed 29535646Rodriguez 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.
PubMed 38025483
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Training Program on Social Cognition for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05866328
- Acronym / sponsor ID
- TP;SC / ULaguna
- Conditions
- Social Cognition
- Keywords
- rehabilitation, schizophrenia, emotional adjustment, theory of mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Collaborators
- University of Santiago de Compostela
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Cognitive rehabilitation with a cognitive training program
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cognitive Rehabilitation and Individual Placement and SupportExperimental Group (e-Motional Training and Individual Placement and Support) |
| Control | No intervention | –Control Group (Individual Placement and Support) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- People with no Severe mental illness and not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Rehabilitation and Individual Placement and SupportAlso: CR and IPSCognitive Rehabilitation and Individual Placement and Support | Other | Intervention |
Primary outcome
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.
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.
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.
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.
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.
Movie for the Assessment of Social Cognition total score changes
Time frame: At baseline and after 1 year treatment
Minimum 0 and maximum 42.
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.
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.
1 secondary outcome
Employment
Time frame: Up to 12 months in 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Results publication: PubMed 28740808Vazquez-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.
- Results publication: PubMed 29535646Marono 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.
- Derived from this study: PubMed 38025483Rodriguez 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.
- Individual participant dataSharing planned: Yes. Publicate the results in a International Journal
Related trials for Social Cognition
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
Enrolling by invitation
Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
Not yet recruitingObservational study
Expression Intensity Modulates Social Intention Understanding in ASD Children
Autism Spectrum Disorder (ASD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Rodriguez Pulido, PHD MD study director
University of La Laguna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation and Individual Placement and Support in people with Social Cognition, run by University of La Laguna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ekman 60 Faces Test total score changes (time frame: At baseline and after 1 year treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866328, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.