Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
Condition: Chronic Low Back Pain; Chronic Neck Pain; Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders; Low Back Pain; Neck Pain
Study type: Interventional

Summary: 
      Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent
      and severely debilitating disorder characterized by tremendous personal and socioeconomic
      impact, long-term sick leave, low quality of life and very high socioeconomical costs. The
      current strategies for treating CSP are not yet optimal in reducing pain and related
      disability, urging the need for improvement. A possible problem is that the current
      approaches are often to limited and only address pain.

      Current treatments for CSP do not address associated complaints like sleeping problems which
      are however important issues. If present, sleeping problems may contribute to CSP severity
      and related disability. If left untreated, they represent a barrier for effective CSP
      management. Up to now, however, sleeping problems are hardly addressed and if so, it is
      mostly limited to sleeping medication. This is a problem since the efficacy and safety of
      drug treatment has not been established.

      Therefore, within the current innovative project we propose examining the added value of
      cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy
      treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene,
      altering sleeping patterns, and teaching relaxation skills.

      The objectives of the study are to examine if CBT-I combined with the modern physical therapy
      approach (education about pain followed by exercise therapy) is more effective than the
      modern physical therapy approach alone for reducing pain, improving sleep and functionality
      in CSP patients with sleeping problems.

      Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2
      treatment programs (60 per group) and will be assessed before and after their 14-week therapy
      program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep
      quality and functionality.
    

Detailed description: 
      Modern pain neuroscience has advanced our understanding of chronic spinal pain (CSP). Despite
      the scientific progresses with regard to the treatment of chronic spinal pain (CSP), current
      treatments for CSP do not address pain comorbidities like insomnia, an important yet seldom
      addressed issue. Treatment of CSP mostly still relies on monotherapies or on biomedical
      models, as shown by expensive but ineffective treatments like lumbar fusion surgery, ignoring
      important comorbidities such as insomnia.

      Within the current innovative project we propose examining the added value of cognitive
      behavioral therapy for insomnia (CBT-I) to the current best evidence treatment for CSP. The
      innovative nature of this approach to CSP goes well beyond the combination of 2 available and
      effective treatments: combining cognitive behavioral therapy for insomnia with the recently
      established modern neuroscience approach (pain neuroscience education followed by
      cognition-targeted exercise therapy) strengthens the content of both individual approaches
      and applies the current understanding regarding insomnia and pain neuroscience to clinical
      practice. This innovative combination will result in a synergistic effect of both treatments.

      The primary scientific objective of the study is to examine if CBT-I combined with a modern
      neuroscience approach (pain neuroscience education followed by cognition-targeted exercise
      therapy) is more effective than the modern neuroscience approach alone for reducing pain in
      CSP patients with insomnia. Secondary objectives of the study are to examine if CBT-I
      combined with the modern neuroscience approach is more effective than the modern neuroscience
      approach alone for improving pain related outcomes, sleep related outcomes and physical
      activity/functionality in CSP patients with insomnia.

      To comply with these scientific objectives, the 120 CSP patients with comorbid insomnia will
      be subjected to the baseline assessment of all outcome measures.

      Follow-up assessments will be performed immediately after 14 weeks of therapy (all tests),
      and 3 months (questionnaires), 6 months (questionnaires) and 12 months (all tests, depending
      on a go/no go decision) after finishing the therapeutic intervention.

      To investigate these objectives, a muli-center triple-blind randomized, controlled trial with
      1 year follow up will be performed.

      Appropriate statistical analyses will be performed to evaluate and compare treatment effects.
      Statistical, as well as clinical significant differences will be defined and the effect size
      will be determined.
    

Intervention name(s): MNA plus CBT-I; MNA alone
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MNA plus CBT-I includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, 6 individual sessions of CBT-I and 9 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. CBT-I is the standard evidence-based care for treating chronic primary insomnia and typically includes changing negative thoughts about sleep, sleep hygiene, sleep restriction therapy, and teaching relaxation skills. The 18 sessions will be spread over a period of 14 weeks.; MNA alone includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, and 15 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. The 18 sessions will be spread over a period of 14 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial will randomize 120 patients with CSP and comorbid insomnia, aged between 18 and 65 years, to the experimental intervention (i.e. 18 sessions of the modern neuroscience approach combined with CBT-I, including 3 sessions of therapeutic pain neuroscience education, 6 sessions of CBT-I and 9 sessions of cognition-targeted exercise therapy, n=60) or the control intervention (i.e. 18 sessions of the modern neuroscience approach alone, including 3 sessions of therapeutic pain neuroscience education, and 15 sessions of cognition-targeted exercise therapy, n=60).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment