Condition category
Nervous System Diseases
Date applied
11/08/2011
Date assigned
31/08/2012
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Long-term occupational exposure to neurotoxic chemicals like toluene, trichloroethylene and benzene is widespread in many industries all over the world and may result in the syndrome Chronic Solvent induced Encephalopathy (CSE). Most patients with CSE do not recover; the disabilities arising from memory and attentional impairment usually continue, severely affecting daily functioning, social participation, working ability, and therefore quality of life. The aim of this study is to evaluate the effects of a psychological treatment programme for patients diagnosed with CSE.

Who can participate?
Patients diagnosed with CSE.

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention group undergo a psychological treatment programme together with care as usual. The control group receive care as usual only.

What are the possible benefits and risks of participating?
Patients may benefit from the psychological treatment being tested. Patients in the control group also received the psychological treatment after the study and therefore may also benefit from the intervention. There are no anticipated side effects from the psychological treatment.

Where is the study run from?
Participants are recruited from the two locations of the Solvent Team in the Netherlands (Amsterdam and Enschede).

When is the study starting and how long is it expected to run for?
March 2002 to June 2006.

Who is funding the study?
Netherlands Center for Occupational Diseases (Netherlands).

Who is the main contact?
Dr Ieke Visser
i.visser@amc.uva.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ieke Visser

ORCID ID

Contact details

Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
-
i.visser@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Neuropsychological rehabilitation in workers with chronic solvent induced encephalopathy (CSE): a randomised controlled trial

Acronym

Study hypothesis

A neuropsychological rehabilitation programme in patients with chronic solvent induced encephalopathy is benefical with respect to:
1. Coping with cognitive impairments
2. Subjective cognitive impairments in meta-memory
3. Health related quality of life

Ethics approval

Academic Medical Centre (AMC) Amsterdam, 14/02/2011, ref: MEC 01/146

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic solvent induced encephalopathy

Intervention

Patient were randomised, either to:
1. Intervention (neuropsychological rehabilitation group programme consisting of: memory training improving coping skills with cognitive impairments, cognitive behavioural therapy and psychosocial interventions aimed at improvement of social functioning)) together with care as usual (continuation of existing treatments) arm (INT + CAU)
2. Care as usual (CAU)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Coping with cognitive impairment (CAMQ)
2. Subjectieve cognitive impairment (CFQ)
3. Meta memory (MIA)
Measured pre-intervention (T0), post intervention at 3 months (T1 ) and at 7 months follow up(T2)

Secondary outcome measures

Health related quality of life (SF-36) measured pre-intervention (T0), post intervention at 3 months (T1) and at 7 months follow up (T2)

Overall trial start date

01/03/2002

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 17 years
2. Diagnosed with chronic solvent induced encephalopathy
3. 5 years or more exposure to organic solvents
4. Cessation of exposure not longer than three yrs before first diagnostic evaluation for CSE
5. Informed consent
6. Dutch speaking

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2 x 35

Participant exclusion criteria

1. Other neurological illness
2. Alcohol or drugs related disorders
3. Psychotic symptoms
4. Radiation therapy
5. Chemotherapy
6. Previous treatment in neuropychological rehabilitation

Recruitment start date

01/03/2002

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Meibergdreef 5
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Netherlands Center for Occupational Diseases (Netherlands)

Sponsor details

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Netherlands Center for Occupational Diseases (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes