Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial

Tobias Wiklund, Peter Molander, Philip Lindner, Gerhard Andersson, Björn Gerdle, Elena Dragioti, Tobias Wiklund, Peter Molander, Philip Lindner, Gerhard Andersson, Björn Gerdle, Elena Dragioti

Abstract

Background: Patients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.

Objective: This randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.

Methods: We included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.

Results: Results showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.

Conclusions: In patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.

Trial registration: ClinicalTrials.gov NCT03425942; https://ichgcp.net/clinical-trials-registry/NCT03425942.

Keywords: CBT-i; RCT; chronic pain; comorbid; digital health; insomnia; mental health; online health; online treatment; pain; rehabilitation; web-based CBT.

Conflict of interest statement

Conflicts of Interest: None declared.

©Tobias Wiklund, Peter Molander, Philip Lindner, Gerhard Andersson, Björn Gerdle, Elena Dragioti. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 29.04.2022.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) 2010 flow diagram. ICBT-i: internet-based cognitive behavioral therapy for insomnia; ISI: Insomnia Severity Index.
Figure 2
Figure 2
Sleep measures for internet-based cognitive behavioral therapy for insomnia (ICBT-i) and applied relaxation over time. Baseline data are presented only for Insomnia Severity Index (ISI). The active treatment period is illustrated by dots, and follow-up data are illustrated by diamonds. Note that y-axes are not illustrated from 0.
Figure 3
Figure 3
Effect sizes (random effects) for internet-based cognitive behavioral therapy for insomnia (ICBT-i) and applied relaxation at week 5 and 6-month follow-up. EMA: early morning awakenings; EQ5-VAS: European Quality of Life 5-Dimension Visual Analog Scale; GAD-7: Generalized Anxiety Disorder–7 items; ISI: Insomnia Severity Index; KSS: Karolinska Sleepiness Scale; NPR: number of pain regions; NRS: Numeric Rating Scale; PDI: Pain Disability Index; PHQ-9: Patient Health Questionnaire–9 items; SE: sleep efficiency; SOL: sleep onset latency; TST: total sleep time; WASO: wake time after sleep onset.

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