Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial
Abstract Background More than half of individuals with chronic pain also experience insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to widespread implementation. This study aims to evaluate the effecti...
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2025-08-01
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| Online Access: | https://doi.org/10.1186/s13063-025-09013-3 |
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| author | Maria Louise Stage Olsen Jonas Bloch Thorlund Robert Zachariae Werner Vach Laila Bendix Julie Jespersen Preben Kidmose Christine Parsons Kristian Kidholm Henrik Bjarke Vægter |
| author_facet | Maria Louise Stage Olsen Jonas Bloch Thorlund Robert Zachariae Werner Vach Laila Bendix Julie Jespersen Preben Kidmose Christine Parsons Kristian Kidholm Henrik Bjarke Vægter |
| author_sort | Maria Louise Stage Olsen |
| collection | DOAJ |
| description | Abstract Background More than half of individuals with chronic pain also experience insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to widespread implementation. This study aims to evaluate the effectiveness of a 9-week app-delivered CBT-I intervention, compared to an app-delivered sleep hygiene education program (active control), in reducing insomnia and pain severity in patients with disabling chronic pain and comorbid insomnia. Methods The trial is a 1:1 randomized, single-blind, superiority trial randomizing 160 patients with disabling chronic pain and comorbid insomnia to either app-delivered CBT-I for 9 weeks or app-delivered sleep hygiene education for 9 weeks. Primary outcomes are the between-group differences in change in Insomnia Severity Index (ISI) and average pain intensity assessed using a 0–10 numeric rating scale (NRS) from baseline to post-interventions. Short-term secondary outcomes post-intervention include perceived effects on sleep and pain (Global Perceived Effect scales), sleep quality, thoughts and beliefs about sleep and pain, physical and mental health, and EQ5D-5L. Medium-term and long-term secondary outcomes (ISI, pain intensity, EQ5D-5L, health care costs, and use of sleep and pain medication) will be collected after 24 and 52 weeks. Exploratory physiological sleep metrics from at-home ear-electroencephalography (EEG) will be collected for five nights at baseline and for five nights during week 8. Discussion This planned study addresses a critical need for identifying effective, safe, and easily accessible alternatives to the current treatments for patients with chronic pain and insomnia. Trial registration ClinicalTrials.gov NCT06361914. Registered on April 17, 2024. |
| format | Article |
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| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj-art-c2916d83baf24106bdfd1ddb185f80702025-08-20T03:06:00ZengBMCTrials1745-62152025-08-0126111510.1186/s13063-025-09013-3Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trialMaria Louise Stage Olsen0Jonas Bloch Thorlund1Robert Zachariae2Werner Vach3Laila Bendix4Julie Jespersen5Preben Kidmose6Christine Parsons7Kristian Kidholm8Henrik Bjarke Vægter9Pain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University HospitalCenter for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern DenmarkDepartment of Oncology, Aarhus University HospitalBasel Academy for Quality and Research in MedicinePain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University HospitalPain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University HospitalDepartment of Electrical and Computer Engineering, Aarhus UniversityDepartment of Clinical Medicine – Interacting Minds Centre, Aarhus UniversityDepartment of Clinical Research, Faculty of Health Sciences, University of Southern DenmarkPain Research Group, Pain Center, Department of Anesthesiology and Intensive Care, Odense University HospitalAbstract Background More than half of individuals with chronic pain also experience insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to widespread implementation. This study aims to evaluate the effectiveness of a 9-week app-delivered CBT-I intervention, compared to an app-delivered sleep hygiene education program (active control), in reducing insomnia and pain severity in patients with disabling chronic pain and comorbid insomnia. Methods The trial is a 1:1 randomized, single-blind, superiority trial randomizing 160 patients with disabling chronic pain and comorbid insomnia to either app-delivered CBT-I for 9 weeks or app-delivered sleep hygiene education for 9 weeks. Primary outcomes are the between-group differences in change in Insomnia Severity Index (ISI) and average pain intensity assessed using a 0–10 numeric rating scale (NRS) from baseline to post-interventions. Short-term secondary outcomes post-intervention include perceived effects on sleep and pain (Global Perceived Effect scales), sleep quality, thoughts and beliefs about sleep and pain, physical and mental health, and EQ5D-5L. Medium-term and long-term secondary outcomes (ISI, pain intensity, EQ5D-5L, health care costs, and use of sleep and pain medication) will be collected after 24 and 52 weeks. Exploratory physiological sleep metrics from at-home ear-electroencephalography (EEG) will be collected for five nights at baseline and for five nights during week 8. Discussion This planned study addresses a critical need for identifying effective, safe, and easily accessible alternatives to the current treatments for patients with chronic pain and insomnia. Trial registration ClinicalTrials.gov NCT06361914. Registered on April 17, 2024.https://doi.org/10.1186/s13063-025-09013-3Chronic painInsomniaSleepCognitive behavioral therapyCBT-IEar-EEG |
| spellingShingle | Maria Louise Stage Olsen Jonas Bloch Thorlund Robert Zachariae Werner Vach Laila Bendix Julie Jespersen Preben Kidmose Christine Parsons Kristian Kidholm Henrik Bjarke Vægter Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial Trials Chronic pain Insomnia Sleep Cognitive behavioral therapy CBT-I Ear-EEG |
| title | Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial |
| title_full | Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial |
| title_fullStr | Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial |
| title_full_unstemmed | Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial |
| title_short | Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial |
| title_sort | digitally delivered cognitive behavioral therapy for insomnia cbt i for patients with chronic pain and insomnia the back2sleep trial study protocol for a randomized controlled trial |
| topic | Chronic pain Insomnia Sleep Cognitive behavioral therapy CBT-I Ear-EEG |
| url | https://doi.org/10.1186/s13063-025-09013-3 |
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