Neuropsychological rehabilitation in patients with impairments in memory and attention after long term occupational exposure to organic solvents
| ISRCTN | ISRCTN33631515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33631515 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/08/2011
- Registration date
- 31/08/2012
- Last edited
- 29/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Contact information
Scientific
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
| i.visser@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Neuropsychological rehabilitation in workers with chronic solvent induced encephalopathy (CSE): a randomised controlled trial |
| 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(s) | Academic Medical Centre (AMC) Amsterdam, 14/02/2011, ref: MEC 01/146 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2002 |
| Overall study end date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2 x 35 |
| 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 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
Study participating centre
1105 AZ
Netherlands
Sponsor information
Government
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/00jtnvh80 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
