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The effect of an add-on treatment for sleep problems in the rehabilitation of patients with acquired brain injury and patients with chronic pain

The effect of an add-on treatment for sleep problems in the rehabilitation of patients with acquired brain injury and patients with chronic pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24225
Enrollment
100
Registered
2021-03-05
Start date
2018-09-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acquired brain injury (traumatic brain injury, stroke, brain tumor, encephalitis, etc.) OR musculoskeletal chronic pain (pain lasting > 6 months).

Interventions

Short add-on treatment for sleep problems (in addition to the regular rehabilitation program). The add-on treatment for sleep problems consists of cognitive behavioural therapy for insomnia (CBT-I) el

Sponsors

No external sponsors. The study is facilitated internally by Rehabilitation Center Klimmendaal.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The treatment will be evaluated in patients with ABI and in patients with chronic pain. In order to be eligible to participate in this study, a patient must meet all of the following criteria: - Self-reported sleep problems which are associated with disability in daily life. - Following rehabilitation treatment for acquired brain injury (traumatic brain injury, stroke, brain tumor, encephalitis, etc.) in a specialized outpatient care. Patients are included if the injury is at least three months ago. OR following rehabilitation treatment for musculoskeletal chronic pain (pain lasting > 6 months). Patients are included if any possible injury for their pain is at least 6 months ago. - Fluent in Dutch. - Age between 18 and 75 - Living independently at home.

Exclusion criteria

Exclusion criteria: - Severe brain damage, such that patients are not able to follow this treatment or complete questionnaires (due to physical or severe cognitive problems), based on clinical judgement - Neurodegenerative disorder (e.g., Parkinson, Multiple Sclerosis) - Diagnosed sleep disorder prior to injury (e.g., apnea, restless legs syndrome) - Serious psychopathology (e.g., risk for psychosis) or suicidality - Alcohol or drug abuse or dependence (use of pain- and sleep medication are not exclusion criteria, unless patients started taking the medication < month ago). If necessary, the use of pain- and sleep medication will be taken into account in our analyses. - Recently started taking pain- (e.g., opioids, analgesics) or sleep medication, less than a month ago

Design outcomes

Primary

MeasureTime frame
Pittsburg Sleep Quality Index (PSQI) - sleep quality

Secondary

MeasureTime frame
Dutch Multi-Factor Fatigue Scale (DMFS) - Fatigue Dysfunctional Beliefs and Attitudes about Sleep Scale brief version (DBAS-16) - dysfuncitonal beliefs about sleep Hospital Anxiety and Depression Scale (HADS) - anxiety and depression symptoms Numeric Pain Rating Scale (NPRS) - pain score in the last 24 hours

Contacts

Public ContactNikita Frankenmolen

Rehabilitation center Klimmendaal

n.frankenmolen@klimmendaal.nl+31612790508

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)