Condition category
Mental and Behavioural Disorders
Date applied
01/02/2017
Date assigned
16/02/2017
Last edited
15/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schizophrenia is a long-term mental health condition that affects how a person thinks, feels and behaves. It can cause hallucinations (hearing and/or seeing things), delusions (believing something that is not true), and changes in behaviour. The causes of schizophrenia are unknown. Schizophrenia is usually treated with a combination of antipsychotic medicine and therapy however patients may still find it hard to manage their symptoms. This can make it hard for people with schizophrenia to find and keep a job. In Spain, there are programmes such as the Individual Placement and Support (IPS) programme that provides support and guidance to those with mental health problems to help them find a job. However, this programme does not have a therapy component that addresses the mental condition of patients. A therapy that addresses cognitive function (mental skills) could be beneficial to those with mental health problems seeking jobs. This study aims to see if the effectiveness of the IPS programme is improved by having additional support that works on improving cognitive function.

Who can participate?
Adults with schizophrenia who are unemployed.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the standard job search support. Those in the second group receive the standard job search support as well using a computer program that aims to improve cognitive functioning (mental skills). This program improves memory, attention, problem-solving, learning and motor skills. Participants also receive feedback, support and strategies for improving the skills they have problems with. Participants are followed up 8 months and one year after the programme to test their cognitive function and to see if they are employed.

What are the possible benefits and risks of participating?
Participants may benefit from the possibility of being employed and improving their cognitive functions through participation in this study. There are no risks to participants.

Where is the study run from?
SINPROMI (Spain)

When is the study starting and how long is it expected to run for?
October 2013 to October 2015

Who is funding the study?
SINPROMI (Spain)

Who is the main contact?
Dr Francisco Rodriguez Pulido
fpulido15@yahoo.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francisco Rodriguez Pulido

ORCID ID

http://orcid.org/0000-0003-1973-5640

Contact details

Carretera General La Cuesta Sn
Santa Cruz De Tenerife
38075
Spain
+34 60 911 65 23
fpulido15@yahoo.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SINPROMI

Study information

Scientific title

Cognitive remediation to improve vocational outcomes for people with psychosis experience: A randomised controlled tiral

Acronym

Study hypothesis

The aim of this study is to determine the effectiveness of the Individual Placement and Support (IPS) model in two groups: one with supported employment only and other with supported employment and cognitive rehabilitation.

Ethics approval

Obtaining ethical approval was unnecessary as there are no psychotherapeutic techniques used in any of the groups as the goal was employment strategies. All participants gave informed consent.

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Condition

1. Schizophrenia
2. Schizoaffective disorder

Intervention

Participants in the Individual Placement and Support programme are randomly allocated to one of two groups using a computer generated randomisation list.
All participants undergo baseline assessment to assess cognitive functioning.

Group one (cognitive rehabilitation group): Participants receive 32 one hour sessions of cognitive rehabilitation as well as the standard employment search support. This involves computer cognitive exercises with COGPACK program (version 8.4). The COGPACK prgoram involves a variety of cognitive activities that measure memory, attention, executive functions, verbal learning and psychomotor speed. The first 6 cognitive training sessions are focused on practicing in all of these areas. The following sessions focus on the cognitive functions that participants struggle with. Sessions take place once or twice a week for 45-60 minutes. Different cognitive exercises are explained and demonstrated. Sessions are individually tailored, and participants are provided with feedback, support and strategies for improving their performance on challenging exercises.

Group two (control group): Participants in the control group receive employment search support according to the standard level of practice.

Follow up is done at 8 months and 1 year post treatment to measure cognitive function (this includes tests that measure memory, attention, executive functions, verbal learning and psychomotor speed).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Employment outcomes are measured through hours worked, wages earned, and job tenure at baseline, 8 months and one year.

Secondary outcome measures

Cognitive outcomes are assessed using Digit Span, Trail Making Test, Rey Auditory Verbal Learning Test, Wisconsin Card Sorting Test and Digit Symbol at baseline, 8 months and one year.

Overall trial start date

10/10/2013

Overall trial end date

10/10/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Meets state definitions of severe mental illness (SMI), that includes psychotic disorders with a CIE-10 diagnosis
2. Difficulties keeping a competitive job
3. Currently desires a competitive job
4. Follow up commitment with the individual placement and support team

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant exclusion criteria

1. Patients with no desire to gain employment

Recruitment start date

15/11/2007

Recruitment end date

20/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

SINPROMI
Góngora s/n
Santa Cruz de Tenerife
38005
Spain

Sponsor information

Organisation

SINPROMI

Sponsor details

Calle Góngora
Santa Cruz de Tenerife
38005
Spain

Sponsor type

Other

Website

Funders

Funder type

Not defined

Funder name

SINPROMI

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact international journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Enrique Gonzalez Davila egonzale@ull.es

Intention to publish date

01/05/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes