Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial

Abstract

Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.

Fig 1.

Screening, random assignment, and completion of postintervention. CBT-I, cognitive behavioral therapy for insomnia; TCC, Tai Chi Chih.

Fig 2.

(A) Treatment response of patients with insomnia (change in Pittsburgh Sleep Quality Index score of ≥ 5 points) at 3 months (post-treatment), 6 months, and 15 months in the cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC) groups. Rate of response is indicated as a percentage of observed cases. Vertical bars indicate range of response with the assumption that missing cases are all responders or nonresponders. Rate of response was similar between the two groups at month 3 (35% and 32.4%, respectively; P = 1.0; d = 0.06) and month 6 (42.5% and 38.2%, respectively; P = .82; d = 0.10), and at the primary outcome end point, month 15 (43.6% and 46.7%, respectively; P = .82; d = −0.07). Effect sizes are reported using the d metric to reflect differences between groups. Positive values indicate CBT-I > TCC, negative values TCC > CBT-I. (B) Percentage of participants with remission of Diagnostic and Statistical Manual (Fourth Edition, Text Revision; DSM-IV-TR) insomnia at 3 months (postintervention), 6 months, and 15 months in the CBT-I and TCC groups. Insomnia diagnosis was made by clinician interview using DSM-IV-TR criteria. Rate of remission is indicated as a percentage of observed cases. Vertical bars indicate range of remission with the assumption that missing cases are all remitters or nonremitters. Rate of remission was similar between the two groups at 3 months (CBT-I, 37.5%; TCC, 32.47%; P = .81), 6 months (CBT-I, 55%; TCC, 34.4%; P = .10), and 15 months (CBT-I, 46.2%; TCC, 37.9%; P = .62).

Fig 3.

Change in global sleep quality from baseline to month 15 follow-up in the cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC) treatment groups. Total scores on the Pittsburgh Sleep Quality Index range from 0 to 21, with higher scores indicating worse sleep quality. Values are means and bars indicate standard error of measurement. Measurements were obtained at baseline 1 (BL1; 2 months before intervention) and baseline 2 (BL2; immediately before intervention), and months 2 (midintervention), 3 (postintervention), and 6 and 15 (follow-up). The numbers of participants evaluated at each time point for each group are as follows: BL1: TCC, n = 45; CBT-I, n = 45; BL2: TCC, n = 45; CBT-I, n = 45; month 2: TCC, n = 38; CBT-I, n = 44; month 3: TCC, n = 38; CBT-I, n = 42; month 6: TCC, n = 35; CBT-I, n = 40; and month 15: TCC, n = 33; CBT-I, n = 40. Shaded area indicates period of exposure to treatment after baseline assessment. Comparisons between BL1 and BL2 were not significant (t_377.7 = 0.2; P = .60). Significant pairwise comparisons were found between BL2 and months 2, 3, 6, and 15 (all P < .001). No significant differences were found between CBT-I and TCC at BL1, BL2, months 3, 6, and 15 (all P > .10), but CBT-I and TCC differed at month 2 (P < .02).

Fig 4.

(A) Change in severity of fatigue symptoms from baseline to month 15 follow-up in the cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC) treatment groups. Higher scores on the Multidimensional Fatigue Symptom Inventory indicate more fatigue severity. Values are means, and bars indicate standard error of measurement. Measurements were obtained at baseline 1 (BL1), baseline 2 (BL2), and months 2, 3, 6, and 15. The numbers of participants evaluated at each time point for each group are as follows: BL1: TCC, n = 45; CBT-I, n = 45; BL2: TCC, n = 45; CBT-I, n = 45; month 2: TCC, n = 38; CBT-I, n = 44; month 3: TCC, n = 38; CBT-I, n = 42; month 6: TCC, n = 35; CBT-I, n = 40; and month 15: TCC, n = 33; CBT-I, n = 40. Shaded area indicates period of exposure intervention after baseline assessment. Comparisons between BL1 and BL2 were not significant (t_374.9 = 1.8; P = .20). Significant pairwise comparisons were found between BL2 and months 2, 3, 6, and 15 (all P < .001). No significant differences were found between CBT-I and TCC at BL1, BL2, months 2, 3, 6, and 15 (all P > .10). (B) Change in clinician-rated severity of depressive symptoms from baseline to month 15 follow-up in the CBT-I and TCC intervention groups. Higher scores on the Inventory of Depressive Symptomology indicate worse depressive symptoms. Values are means, and bars indicate standard error or measurement. Measurements were obtained at BL1, BL2, and months 2, 3, 6, and 15. The numbers of participants evaluated at each time point for each group are as follows: BL1: TCC, n = 45; CBT-I, n = 45; BL2: TCC, n = 45; CBT-I, n = 45; month 2: TCC, n = 38; CBT-I, n = 44; month 3: TCC, n = 38; CBT-I, n = 42; month 6: TCC, n = 35; CBT-I, n = 40; and month 15: TCC, n = 33; CBT-I, n = 40. Shaded area indicates period of administration of intervention after baseline assessment. Comparisons between BL1 and B2 were not significant (t_371.5 = 0.7; P = .34). Significant pairwise comparisons were found between BL2 and months 2, 3, 6, and 15 (all P < .01). No significant differences were found between CBT-I and TCC at BL1, BL2, months 2, 3, 6 and 15 (all P > .10).