Sleep Latency

Importance: Insomnia is highly prevalent among individuals with chronic disease (eg, chronic pain, cardiovascular disease, and cancer) and results in poorer disease outcomes and quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as first-line treatment for insomnia. However, concerns remain about its applicability and efficacy in people with chronic disease.

Objective: To evaluate the nature, efficacy, and acceptability of CBT-I in adults with chronic disease, and to identify moderators of treatment outcomes.

Data sources: Systematic searches were conducted in PsycINFO, Medline, Embase, and CENTRAL from database inception to June 5, 2025. Additional records were identified from reference lists of relevant reviews and studies.

Study selection: Eligible studies were randomized clinical trials (RCTs) involving adults (aged ≥18 years) with chronic disease and insomnia. Studies using CBT-I with measured sleep outcomes were included.

Data extraction and synthesis: Two assessors extracted data from RCTs. Hedges g was used to calculate effect sizes, and random effects meta-analyses were conducted. Heterogeneity was assessed via I2. Subgroup analyses examined whether outcomes varied by delivery format, chronic condition type, or control group.

Main outcomes and measures: Primary outcomes included insomnia severity, sleep efficiency, and sleep onset latency. Secondary outcomes included treatment acceptability and adverse effects.

Results: Sixty-seven RCTs (5232 participants) met inclusion criteria, including chronic diseases such as cancer, chronic pain, irritable bowel syndrome, and stroke. CBT-I was associated with significantly improved outcomes for insomnia severity (g = 0.98; 95% CI, 0.81-1.16) and moderate effect sizes regarding sleep efficiency (g = 0.77; 95% CI, 0.63-0.91) and sleep onset latency (g = 0.64; 95% CI, 0.50-0.78). Subgroup analyses revealed some sample, treatment, and methodological moderators (eg, longer treatment yielded better outcomes for sleep efficiency and sleep onset latency). Satisfaction with CBT-I was high, with a mean dropout rate of 13.3%. Treatment-related adverse effects were rare.

Conclusions and relevance: This systematic review and meta-analysis showed that CBT-I demonstrated strong efficacy and acceptability in chronic disease populations, with moderate to large effect sizes that appear comparable to those in non-chronic disease populations. Efficacy of CBT-I was similar across a range of disease subgroups. Future research should explore the role and nature of treatment adaptations for specific populations and increase access to CBT-I in medical settings.