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ID
Source
Brief title
Health condition
Spinal cord injury
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective information by the participants (patients and professionals) gathered by semi-structured interview
Secondary outcome
Psychological distress (HADS)
Fatigue (NRS)
Mindfulness skills (FFMQ-SF)
Quality of life (ISCIQoL Basic Data Set)
Self-efficacy (UWSES-6)
Pain intensity (NRS)
Pain catastrophizing (The Pain Catastrophizing Scale)
Background summary
Rationale: An average of 25% of people with spinal cord injury (SCI) experience psychological distress. Previous preliminary research showed that mindfulness-based interventions such as mindfulness-based cognitive therapy (MBCT) can help people with SCI to relieve their distress. However, to date MBCT took place in different forms; online, in person individually or in groups.
Objective: The main aim of this project is to evaluate the process of customization and implementation of an in person group based MBCT for people with SCI in a rehabilitation setting. Secondly, to investigate the effect and consolidation of the customized in person group based MBCT for people with SCI.
Study design: The current study is a process evaluation study.
Study population: Adults (>18 years, N=25) with SCI who are more than one year post injury.
Intervention: Patients will enter in an in person group based MBCT, consisting of weekly sessions (9 group meetings). The group will exist of a maximum of 9 persons with SCI. If present, one significant other of the patient will be invited.
Main study parameters/endpoints: Primary outcome for the customization of MBCT and implementation of MBCT will be qualitative information received from all parties involved. For the secondary aim the primary outcome will be the severity of psychological distress posttreatment, assessed with the Hospital Anxiety and Depression Scale (HADS)1.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden associated with participation in the evaluation study is relatively low. Participants in this study might be asked to participate in a semi structured qualitative interview concerning MBCT, how they experienced this, what was helpful and what not. These interviews will be conducted for the participants in the first group. Further all participants will be asked to fill out a questionnaire at four different timepoints; before the start of MBCT; just after the training; three months after the training and six months after the training. The risks associated with participation are expected to be low.
Study objective
Mindfulness Based Cognitive Therapy can be customized without major changes to the standard program.
The implementation will formally depend on practical aspects that can be resolved.
Study design
pre MBCT
post MBCT
3 months post MBCT
6 months post MBCT
Intervention
Mindfulness Based Cognitive Therapy (MBCT)
Inclusion criteria
Diagnosed with SCI, any height or completeness
Over age of 18
Good command of the Dutch language
Willingness to participate in the MBCT intervention
Exclusion criteria
Unable to travel to the Sint Maartenskliniek
Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, suicidal thoughts)
Alcohol or drug dependence
Severe cognitive impairments
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9660 |
| Other | METC Radboud University : Filenumber: 2021-13027 |