Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Early CBT in TWD-MSD (Temporary Work Disability-MusculoSkeletal Disorders)
Study hypothesis
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
Ethics Committee of Clinical Investigation, Hospital Clínico San Carlos, approved on 30 June 2004 (ref: 0-04/139).
Study design
Randomized controlled study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/10/2004
Overall trial end date
15/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Musculoskeletal disorders-related temporary work disability for at least 3 weeks
2. Admitted to the rheumatologic specialized care
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Patients with more than 8 weeks MSD-related temporary work disability.
Recruitment start date
15/10/2004
Recruitment end date
15/04/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Rheumatology
Madrid
28040
Spain
Sponsor information
Organisation
Musculoskeletal Disease Foundation and FREMAP Foundation
Sponsor details
Ercon Consultores
Calle Jorge Juan 78
Madrid
28009
Spain
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Foundation for Biomedical Investigation (Fundación para la Investigación Biomédica, Hospital Clinico San Carlos) (Spain)
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