Cost-effectiveness of an early Cognitive Behavioral Treatment in work disability due to musculoskeletal disorders
| ISRCTN | ISRCTN17984927 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17984927 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/06/2007
- Registration date
- 27/06/2007
- Last edited
- 27/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Juan Angel Jover
Scientific
Scientific
Rheumatology
Hospital Clinico San Carlos
Martin Lagos s/n
Madrid
28040
Spain
Study information
| Study design | Randomized controlled study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Cost-effectiveness of an early Cognitive Behavioral Treatment in work disability due to musculoskeletal disorders |
| Study acronym | Early CBT in TWD-MSD (Temporary Work Disability-MusculoSkeletal Disorders) |
| Study objectives | To evaluate whether a Cognitive Behavioral Treatment (CBT), complementary to a rheumatologic specific program, offered to patients with poor evolution of work disability caused by musculoskeletal disorders (MSDs) is cost-effective. |
| Ethics approval(s) | Ethics Committee of Clinical Investigation, Hospital Clínico San Carlos, approved on 30 June 2004 (ref: 0-04/139). |
| Health condition(s) or problem(s) studied | Musculoskeletal disorders-related temporary work disability |
| Intervention | A psychologist will deliver CBT that is complementary to a rheumatologic specific program. One session lasts 45 minutes. The number of sessions is not previously fixed, and varies between 1 and a maximum of 8. The control group will receive standard care. |
| Intervention type | Other |
| Primary outcome measure | Efficacy was defined as the differences between groups in the following (assessed for each participant 6 months after inclusion into the study): 1. Duration of all MSD-TWD episodes 2. Number of MSD-TWD episodes per patient 3. Number or relapses of MSD-TWD episodes 4. Duration or relapses of MSD-TWD episodes 5. Number and outcome of proposal for permanent work disability |
| Secondary outcome measures | Cost measures |
| Overall study start date | 15/10/2004 |
| Completion date | 15/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Musculoskeletal disorders-related temporary work disability for at least 3 weeks 2. Admitted to the rheumatologic specialized care |
| Key exclusion criteria | Patients with more than 8 weeks MSD-related temporary work disability. |
| Date of first enrolment | 15/10/2004 |
| Date of final enrolment | 15/04/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Rheumatology
Madrid
28040
Spain
28040
Spain
Sponsor information
Musculoskeletal Disease Foundation and FREMAP Foundation
Research organisation
Research organisation
Ercon Consultores
Calle Jorge Juan 78
Madrid
28009
Spain
| Website | http://www.fremap.es/ |
|---|
Funders
Funder type
Hospital/treatment centre
Foundation for Biomedical Investigation (Fundación para la Investigación Biomédica, Hospital Clinico San Carlos) (Spain)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/06/2009 | 27/10/2021 | Yes | No |
Editorial Notes
27/10/2021: Publication reference added.
