Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial
Abstract Background Digital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We ai...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01087-z |
| _version_ | 1818228227163815936 |
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| author | Kevin K. N. Ho Milena Simic Marina B. Pinheiro Christopher B. Miller Manuela L. Ferreira Ronald R. Grunstein John L. Hopper Juan R. Ordoñana Paulo H. Ferreira |
| author_facet | Kevin K. N. Ho Milena Simic Marina B. Pinheiro Christopher B. Miller Manuela L. Ferreira Ronald R. Grunstein John L. Hopper Juan R. Ordoñana Paulo H. Ferreira |
| author_sort | Kevin K. N. Ho |
| collection | DOAJ |
| description | Abstract Background Digital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We aimed to determine the feasibility of a trial investigating the efficacy of a digital CBT-i program in people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons). Methods Thirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (> 6 weeks duration) were randomized to digital CBT-i (intervention) or educational program (control) for 6 weeks. The digital CBT-I, Sleepio (developed by Big Health Inc.), was an online interactive, automated, personalized course comprising of six sessions, once a week. The education program was six emails with general sleep information, once a week. Participants were blinded to their group allocation and offered the alternative intervention at the completion of the study. Feasibility outcomes included recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants’ experience of the intervention. Results Sixteen out of 722 contacted twin pairs were recruited (recruitment rate = 2.2%). Twins were recruited between September 2015 and August 2018 (35 months) and singletons between October 2017 and Aug 2018 (10 months). Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively. Adherence rates (percentage of sessions completed out of six) for the digital CBT-i were 63% for twins and 55% for singletons. Contamination (speaking about the study to each other) was present in two twin pairs (13%). Written or verbal feedback (n = 21) regarding the digital CBT-i intervention from participants were positive (n = 11), neutral (n = 5), or negative (n = 6). Conclusions Online CBT-i was received favorably with people with comorbid symptoms of insomnia and LBP. While the online data collection was successful, strategies need to be implemented to improve adherence, follow-up, control group credibility (for digital CBT-i), and twin recruitment rates (for twin trials). Trial registration Australian New Zealand Clinical Trials Registry ( ACTRN12615000672550 ). Registered 29 June 2015 |
| first_indexed | 2024-12-12T09:59:21Z |
| format | Article |
| id | doaj.art-a72424c83fc1452c9f6cc8c3ca897ff6 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-12T09:59:21Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-a72424c83fc1452c9f6cc8c3ca897ff62022-12-22T00:28:01ZengBMCPilot and Feasibility Studies2055-57842022-06-018111410.1186/s40814-022-01087-zEfficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trialKevin K. N. Ho0Milena Simic1Marina B. Pinheiro2Christopher B. Miller3Manuela L. Ferreira4Ronald R. Grunstein5John L. Hopper6Juan R. Ordoñana7Paulo H. Ferreira8Faculty of Medicine and Health, The University of SydneyFaculty of Medicine and Health, The University of SydneyFaculty of Medicine and Health, The University of SydneyBig Health Inc.Institute of Bone and Joint Research, The Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of SydneyCIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney and Royal Prince Alfred HospitalCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of MelbourneMurcia Twin Registry, Department of Human Anatomy and Psychobiology, University of Murcia, and IMIB-ArrixacaFaculty of Medicine and Health, The University of SydneyAbstract Background Digital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We aimed to determine the feasibility of a trial investigating the efficacy of a digital CBT-i program in people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons). Methods Thirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (> 6 weeks duration) were randomized to digital CBT-i (intervention) or educational program (control) for 6 weeks. The digital CBT-I, Sleepio (developed by Big Health Inc.), was an online interactive, automated, personalized course comprising of six sessions, once a week. The education program was six emails with general sleep information, once a week. Participants were blinded to their group allocation and offered the alternative intervention at the completion of the study. Feasibility outcomes included recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants’ experience of the intervention. Results Sixteen out of 722 contacted twin pairs were recruited (recruitment rate = 2.2%). Twins were recruited between September 2015 and August 2018 (35 months) and singletons between October 2017 and Aug 2018 (10 months). Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively. Adherence rates (percentage of sessions completed out of six) for the digital CBT-i were 63% for twins and 55% for singletons. Contamination (speaking about the study to each other) was present in two twin pairs (13%). Written or verbal feedback (n = 21) regarding the digital CBT-i intervention from participants were positive (n = 11), neutral (n = 5), or negative (n = 6). Conclusions Online CBT-i was received favorably with people with comorbid symptoms of insomnia and LBP. While the online data collection was successful, strategies need to be implemented to improve adherence, follow-up, control group credibility (for digital CBT-i), and twin recruitment rates (for twin trials). Trial registration Australian New Zealand Clinical Trials Registry ( ACTRN12615000672550 ). Registered 29 June 2015https://doi.org/10.1186/s40814-022-01087-zSleepLow back painRandomized control trialTwinsDigitalInsomnia |
| spellingShingle | Kevin K. N. Ho Milena Simic Marina B. Pinheiro Christopher B. Miller Manuela L. Ferreira Ronald R. Grunstein John L. Hopper Juan R. Ordoñana Paulo H. Ferreira Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial Pilot and Feasibility Studies Sleep Low back pain Randomized control trial Twins Digital Insomnia |
| title | Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial |
| title_full | Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial |
| title_fullStr | Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial |
| title_full_unstemmed | Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial |
| title_short | Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial |
| title_sort | efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain a feasibility randomized co twin and singleton controlled trial |
| topic | Sleep Low back pain Randomized control trial Twins Digital Insomnia |
| url | https://doi.org/10.1186/s40814-022-01087-z |
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