Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain

NCT06771856

Chronic Spinal Pain

RECRUITING NA

Internet-based CBT for Insomnia in Chronic Pain

NCT03075683

Chronic Insomnia Chronic Pain

COMPLETED NA

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

NCT02688569

Chronic Widespread Pain Chronic Insomnia

COMPLETED NA

Resilience Enhancement Following Sleep Treatment

NCT07298941

Chronic Low Back Pain (CLBP) Insomnia

RECRUITING PHASE2

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

NCT00133601

Insomnia Chronic Pain

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain Chronic Neck Pain Insomnia Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modern Neuroscience Approach (MNA) plus CBT-I

MNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia)

Group Type EXPERIMENTAL

MNA plus CBT-I

Intervention Type BEHAVIORAL

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

The MNA (i.e. modern pain neuroscience approach) alone

Group Type ACTIVE_COMPARATOR

MNA alone

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MNA plus CBT-I

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.

Intervention Type BEHAVIORAL

MNA alone

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Nonspecific spinal pain for at least 3 months' duration, at least 3 days per week
* Seeking care because of neck pain or low back pain
* Native Dutch speaker
* Having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as \> 30 minutes of sleep latency and/or minutes awake after sleep onset for \> 3 days / week for \> 6 months
* Living or working within a radius of 50 km around the therapy location
* Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
* Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments
* Nonspecific failed back surgery \> 3 years are permitted
* Not undertaking exercise (\> 3 metabolic Equivalents) 3 days before the assessments

Exclusion Criteria

* Severe underlying sleep pathology (identified through baseline data of polysomnography)
* Neuropathic pain
* Chronic widespread pain
* Being pregnant or pregnancy (including given birth) in the preceding year
* History of specific spinal surgery
* Thoracic pain in absence of neck or low back pain
* Shift workers
* Diagnosed depression
* Body Mass Index below 30

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No