Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

Abstract

Purpose Cancer-related insomnia is associated with diminished quality of life (QOL), suggesting that improvement in insomnia may improve QOL in cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia, but less is known regarding its effect on QOL and whether improvement in insomnia corresponds to improved QOL. The present analysis examines the effects of CBT-I, with and without armodafinil, on QOL both directly and indirectly through improvements of insomnia. Methods This is an analysis of 95 cancer survivors for a specified secondary aim of a 4-arm randomized controlled trial assessing the combined and individual effects of CBT-I and armodafinil to improve insomnia. QOL and insomnia severity were assessed before, during the intervention, at post-intervention, and three months later by Functional Assessment of Cancer Therapy-General and Insomnia Severity Index, respectively. Results Mean change in QOL from pre- to post-intervention for CBT-I+placebo, CBT-I+armodafinil, armodafinil, and placebo was: 9.6 (SE=1.8; p<0.0001), 11.6 (SE=1.8; p<0.0001), −0.2 (SE=3.2; p=0.964), and 3.3 (SE=2.0; p=0.124), respectively. ANCOVA controlling for pre-intervention scores showed that participants receiving CBT-I had significantly improved QOL at post-intervention compared to those not receiving CBT-I (p<0.0001, effect size=0.57), with benefits being maintained at the three-month follow-up. Path analysis revealed that this improvement in QOL was due to improvement in insomnia severity (p=0.002), and Pearson correlations showed that changes in QOL from pre- to post-intervention were significantly associated with concurrent changes in insomnia severity (r=−0.56; p<0.0001). Armodafinil had no effect on QOL for those who did or did not receive it (p=0.976; effect size=−0.004). Conclusion In cancer survivors with insomnia, CBT-I resulted in clinically significant improvement in QOL via improvement in insomnia. This improvement in QOL remained stable even three months after completing CBT-I. Implications for Cancer Survivors Considering the high prevalence of insomnia and its detrimental impact on QOL in cancer survivors and the effectiveness of CBT-I in alleviating insomnia, it is important that evidence-based non-pharmacological sleep interventions such as CBT-I be provided as an integral part of cancer care.

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial

“…It is well established that CBT is the first-line treatment for people with chronic insomnia 14,[17][18][19]21,22 and that sleep-related outcomes, whether on index measures of insomnia or on derivations from sleep diaries, show sustained improvement. 17 The findings from this study confirm large effects on insomnia symptoms.…”

“…[17][18][19] Moreover, recent meta-analyses indicate that digital CBT (dCBT), delivered using automated web platforms or a mobile app, 20 is also efficacious. 21,22 The effects of CBT and dCBT on the nighttime symptoms of insomnia, therefore, appear robust. However, daytime symptoms are a core part of insomnia disorder, integral to its clinical presentation.…”

New Method for Insomnia Mongolian Mind–Body Interactive Psychotherapy in the Assessment of Chronic Insomnia: A Retrospective Study

“…However, CBT-I has been well addressed by numbers of studies and found to be an active form of treatment for insomnia [14]. CBT-I is also useful in the treatment of insomnia related to or caused by mood disorders, pain, alcohol-related disorders, arthritis or coronary artery disease [15][16][17][18][19][20][21]. Those who suffer from PTSD have also shown improvementa [15].…”

Psychological support for patients with cancer: evidence review and suggestions for future directions

“…[INSERT CBT is adaptable across clinical presentations and recently published trials include tailoring for: FCR [45*,51*]; clinically-elevated distress [40]; insomnia [36,39,40,44,48]; sexual dysfunction [43,55]; depression and/or anxiety [33,40,41**,47,50*]; fatigue [49]; symptom clusters [35,46]; hot flushes [34]; and broader non-specific psychosocial coping [53][54][55] Whilst this evidence is promising, much of it derives from trials under 'ideal' conditions. Few pragmatic trials have been conducted, and it remains unclear how well CBT works in 'real world' settings -for example, in patients with complex physical or psychological comorbidities.…”