Key messages
• Cognitive behavioural therapy for insomnia (CBT-I) – a type of talk therapy that helps people notice unhelpful thoughts, challenge them, and learn healthier ways to think and behave – may slightly reduce insomnia severity and may slightly improve sleep quality in people with cancer compared to other treatments, but we are very uncertain about these findings.
• CBT-I does not appear to lead to unwanted, harmful events, but we are also uncertain about this result.
• Future research should focus on understanding how people with different types of cancer and in different cancer treatment phases respond to CBT-I.
Why is insomnia an issue for people with cancer?
Many people with cancer struggle with insomnia; that is, they have trouble sleeping, even when they have the chance to sleep. People with cancer are more likely to have insomnia than the general population. They may have trouble sleeping because of pain, stress, worry, or side effects from cancer treatment. Not sleeping well can make them feel more tired, anxious, or depressed, and can make it harder to cope with cancer and its treatment.
How is insomnia in people with cancer treated?
There are two main ways to treat insomnia: medication or non-medicinal approaches such as CBT-I and exercise. CBT-I is a structured therapy that helps people learn how to think differently about sleep, understand how sleep works, and use practical tools such as:
• creating better sleep habits;
• training the brain to connect bed with sleep;
• limiting time in bed to improve sleep quality.
Although CBT-I is widely recognised as the first-choice treatment for managing insomnia in the general population, its effectiveness in people with cancer still needs thorough, up-to-date, and detailed evaluation.
What did we want to find out?
We wanted to know if CBT-I was better than (1) no active treatment or (2) other treatments in improving people's insomnia severity, sleep quality, and sleep diary parameters, meaning things like when they went to bed, how long it took to fall asleep, and how many times they woke up during the night. We also wanted to know if CBT-I led to any serious unwanted or harmful events.
What did we do?
We looked for studies that compared CBT-I with other treatments for people with cancer. We compared and summarised the results of the studies and rated our confidence in the evidence.
What did we find?
We found 21 studies involving 2431 people, predominantly female adults diagnosed with breast cancer. Seventeen of 21 studies were conducted in North America. We identified five comparisons. In this summary, we present the results of the two main comparisons:
• CBT-I versus no active treatment;
• CBT-I versus aerobic activities.
Main results
CBT-I versus no active treatment
In people with cancer, CBT-I may slightly improve insomnia severity, sleep quality, and most sleep diary parameters without introducing additional unwanted or harmful events. However, we are very uncertain about the results for insomnia severity, how often or how soon people wake up after falling asleep, and serious unwanted, harmful events.
CBT-I versus aerobic activities
CBT-I may slightly improve insomnia severity and sleep quality without introducing additional serious unwanted or harmful events. However, CBT-I may result in little to no difference in most sleep diary parameters. We are very uncertain about the results for serious unwanted or harmful events and total sleep duration recorded by sleep diary.
What are the limitations of the evidence?
We are not confident in the evidence because people in the studies might have known which treatment they were receiving, which could have affected how they responded to the treatment. In addition, there were too few studies to be certain about the results for our outcomes of interest.
How current is this evidence?
This evidence is current to April 2025.
阅读完整摘要
Insomnia is a prevalent and distressing issue for individuals with cancer, negatively impacting their overall well-being. While cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia in the general population, its effects on cancer populations warrant rigorous, ongoing evaluation. Previous meta-analyses assessing CBT-I against specific comparators in people with cancer have often exhibited methodological limitations. Furthermore, with a recent increase in randomised controlled trials (RCTs) in this field, an updated and comprehensive synthesis is necessary.
研究目的
To assess the effects of cognitive behavioural therapy for insomnia (CBT-I) in people with cancer.
检索策略
In April 2025, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and clinical trials registries. We also checked reference lists. We applied no language, publication date, or study setting restrictions.
纳入排除标准
We included all RCTs that compared the effects of CBT-I with other treatments in individuals diagnosed with both insomnia and cancer. We placed no restrictions on the specific characteristics of the CBT-I interventions or the comparator groups. We excluded quasi-randomised and cross-over trials.
资料收集与分析
We used random-effects meta-analysis for our primary analyses. Our critical outcomes were: insomnia severity (Insomnia Severity Index (ISI), range 0 to 28), sleep quality (Pittsburgh Sleep Quality Index (PSQI), range 0 to 21), and serious adverse events (SAEs). Important outcomes were sleep diary-derived parameters: sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE). We also analysed objective sleep parameters for the comparisons presented in the summary of findings (SoF) tables. We used the Cochrane risk of bias 2 (RoB 2) tool to assess risk of bias and the GRADE approach to assess evidence certainty. We interpreted findings for continuous outcomes against minimally important differences (MIDs).
主要结果
We included 21 RCTs (2431 randomised participants, predominantly female adults). Participants had received treatment for a range of cancer types, with breast cancer being the most frequently studied, and most were cancer survivors undergoing or following cancer treatment. CBT-I was typically delivered via therapist-led sessions or digital programs (four to 12 weeks). We identified five comparisons and summarised the findings for the two primary comparisons, with outcomes assessed at the conclusion of CBT-I treatment. The risk of bias was often high. Overall, CBT-I may offer small subjective improvements in insomnia for cancer survivors, and the evidence certainty was mostly low to very low. Benefits on objective measures are less clear.
CBT-I versus inactive control
Compared to inactive control post-intervention, CBT-I may slightly reduce ISI scores (mean difference (MD) –5.86 points, 95% confidence interval (CI) –7.22 to –4.51; 14 studies, 1371 participants; very low-certainty evidence) and PSQI scores (MD –3.60 points, 95% CI –4.95 to –2.24; 3 studies, 473 participants; low-certainty evidence). CBT-I may result in little to no difference in the occurrence of SAEs (risk ratio (RR) 1.05, 95% CI 0.07 to 16.77; 4 studies, 765 participants; very low-certainty evidence).
Regarding sleep diary outcomes, CBT-I probably reduces SOL (MD –13.35 min, 95% CI –17.18 to –9.51; 9 studies, 760 participants; moderate-certainty evidence), may reduce WASO (MD –15.39 min, 95% CI –25.23 to –5.56; 9 studies, 784 participants; very low-certainty evidence), and may improve SE very slightly (MD 7.84%, 95% CI 3.62 to 12.06; 9 studies, 725 participants; very low-certainty evidence). CBT-I may result in little to no difference in TST (MD 6.43 min, 95% CI –8.30 to 21.16; 10 studies, 899 participants; very low-certainty evidence).
Regarding objective sleep outcomes, CBT-I may result in little to no difference in SOL (MD –4.54 min, 95% CI –9.91 to 0.84; 2 studies, 129 participants), WASO (MD –5.08 min, 95% CI –10.62 to 0.46; 3 studies, 242 participants), TST (MD –11.01 min, 95% CI –29.35 to 7.33; 4 studies, 521 participants), and SE (MD 1.35%, 95% CI 0.08 to 2.63; 5 studies, 571 participants).
CBT-I versus aerobic activities
Compared to aerobic activities post-intervention, CBT-I may reduce ISI scores (MD –3.53 points, 95% CI –4.43 to –2.62; 2 studies, 406 participants; low-certainty evidence) and PSQI scores (MD –1.67 points, 95% CI –2.63 to –0.72; 3 studies, 496 participants; low-certainty evidence). CBT-I may result in little to no difference in the occurrence of SAEs (RR 0.35, 95% CI 0.04 to 3.36; 2 studies, 579 participants; very low-certainty evidence).
Regarding sleep diary outcomes, CBT-I may result in little to no difference in SOL (MD –6.15 min, 95% CI –13.07 to 0.78; 2 studies, 131 participants; low-certainty evidence), WASO (MD –6.35 min, 95% CI –15.30 to 2.61; 2 studies, 131 participants; low-certainty evidence), and TST (MD 0.40 min, 95% CI –21.10 to 21.90; 2 studies, 131 participants; very low-certainty evidence). However, CBT-I may slightly increase SE (MD 4.24%, 95% CI 0.45 to 8.02; 2 studies, 131 participants; low-certainty evidence).
Regarding objective sleep outcomes, CBT-I may result in little to no difference in SOL (MD 6.07 min, 95% CI –1.47 to 13.62; 2 studies, 131 participants), WASO (MD 6.16 min, 95% CI –3.80 to 16.11; 2 studies, 131 participants), and SE (MD –0.90%, 95% CI –2.84 to 1.04; 3 studies, 416 participants), and may lead to shorter TST (MD –13.02 min, 95% CI –25.00 to –1.04; 3 studies, 416 participants).
作者结论
This Cochrane review found very low-certainty to moderate-certainty evidence suggesting that CBT-I may offer small to very small improvements in patient-reported insomnia severity, sleep quality, and most subjective sleep diary parameters when compared with inactive controls. Against aerobic activities, low-certainty evidence indicates that CBT-I may also improve insomnia severity and sleep quality. The incidence of SAEs appeared similar between CBT-I and comparator groups, and the certainty of this evidence is very low.
The decision to use CBT-I to treat insomnia in people with cancer might depend on the treatment's availability and cost, as well as clinicians' and patients' preferences. Future research requires long-term, larger, and more rigorously designed studies that are inclusive and diverse.
