Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01971151
Eligibility Criteria:
Inclusion Criteria:
* Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months
* Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and
* Moderate to high levels of pain-related fear (TSK \> 37 or at least 4 items with a score of 3 or \>3)
* Have a partner willing to participate
Exclusion Criteria:
* Specific medical disorder or cardiovascular disease preventing participation in physical exercise
* Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology.
* Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session.
* Illiteracy
* Pregnancy
* Involvement in litigation concerning the patient's ability to work or disability income
* Non-Dutch speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01971151
Study Brief:
Protocol Section:
NCT01971151