Treating Insomnia with CBT in Women with Breast Cancer

Institution: University of California, San Diego
Investigator(s): Lavinia Fiorentino, Ph.D. -
Award Cycle: 2005 (Cycle 11) Grant #: 11GB-0049 Award: $73,218
Award Type: Dissertation Award
Research Priorities
Community Impact of Breast Cancer>Sociocultural, Behavioral, and Psychological Issues: the human side



Initial Award Abstract (2005)
Introduction: It has been reported that women with breast cancer have complaints about poor sleep, insomnia, and fatigue. Research has shown that these complaints may persist years after treatment and that they may represent a significant source of distress and diminished quality of life. Only one study has analyzed the effects of treating insomnia with Cognitive Behavioral Therapy (CBT) in women with breast cancer and it found significant improvements in sleep efficiency, total sleep time, mood and cognitive aspects of quality of life. However, this study did not have a control group and so questions about possible placebo effects still need to be addressed.

The main objective of this research is to evaluate the efficacy of group CBT sessions for insomnia in women with breast cancer. A secondary objective of this research is to study the effect of group CBT insomnia treatment on variables often related to insomnia such as fatigue, depression, anxiety, and quality of life.

Hypothesis: CBT will be effective in improving objective and subjective insomnia in women with breast cancer. Is cognitive behavioral therapy an efficacious treatment for insomnia (measured both objectively and subjectively) in women with breast cancer? Hypothesis: Improving insomnia will result in improved quality of life, decreased fatigue, improved mood, and decreased anxiety Does treating insomnia with CBT in women with breast cancer improve quality of life, and decrease levels of fatigue, depression and anxiety?

Methodology: Twenty-four women who survived breast cancer and who have completed chemotherapy or radiotherapy but still suffer from insomnia with no other psychiatric disorder (DSM IV-R guidelines) or medical illness will be recruited. The 24 women will be randomly assigned to either a six week manualized group CBT for insomnia condition or a six week treatment as usual condition (i.e., control group).

The two groups will be compared on objective sleep measures (actigraphy) corroborated by sleep diaries, and standardized questionnaires on insomnia (ISI), sleep quality (PSQI), daytime functional outcomes of sleepiness (FOSQ), fatigue (MFSI), quality of life (SF36), depression (CESD), and anxiety (BSI-18). Data will be collected before the start of treatment and six weeks later at the end of treatment.

Impact on breast cancer: Insomnia is a debilitating condition that affects many aspects of daily life such as daytime sleepiness, energy, attention, cognitive functioning, and mood. When survivors of breast cancer experience insomnia the healing process from the traumatic, psychologically and physically distressing event might be weakened by the direct effects of the insomnia or other correlated symptoms. If so, successfully treating insomnia in breast cancer survivors would significantly improve health and quality of life in this population.

Advocacy involvement: Advocacy websites (e.g., www.breastcancer.orq, www.bcaction2rg, www.y-me.org) will be frequently visited. Information on general and the specific sleep, fatigue and quality of life needs in this population will be sought out in order to gear the intervention towards taking care of those needs. We are integrally involved with the UCSD community outreach program's efforts to help women cope with and find solutions for cancer related fatigue. Particular attention is placed on the needs of the underserved minorities. Dr. Sadler, our co-investigator, is the UCSD Cancer Center's Associate Director for Community Outreach and works closely with ustincrease advocacy involvement.


Final Report (2007)
Insomnia is characterized by complaints of difficulty initiating or maintaining sleep, or non-restorative sleep which last for at least one month and which cause clinically significant distress or impairment in functioning. Estimates of insomnia in women with breast cancer range from approximately 20% to 70%, with reports of poor sleep lasting for years after completion of the cancer treatment. Insomnia in breast cancer patients is often associated with depression, anxiety, fatigue, and low quality of life.

This study aimed at understanding whether an individual cognitive behavioral treatment for insomnia (CBT-I) would result in improvements in sleep as well as improvements in fatigue, depression, anxiety and quality of life (QOL) in breast cancer survivors. Fourteen breast cancer survivors (age M= 61, SD=11.6, range = 45-85) were randomly assigned to either 6 weeks of CBT-I followed by 6 weeks of follow up, or 6 weeks of treatment as usual (TAU) followed by 6 weeks of CBT-I.

The hypotheses tested were that subjective and objective measures of sleep would improve during CBT-I compared to during TAU, that the QOL, fatigue, depression and anxiety would improve during CBT-I compared to during TAU, and that the effects of CBT-I on sleep and other symptoms would be maintained at 6 weeks. The results revealed that the participants assigned to receiving the CBT-I in the first six weeks had improved self-rated insomnia after treatment compared to the participants assigned to TAU (Insomnia severity index. Post-CBT-I: M=12.20, SD=6.57, range=2-19; Post-TAU: M=20.71, SD=3.99, range=16-26, p=0.03). The pooled analyses of pre and post CBT-I treatment for all 14 participants revealed significant improvements in self-rated insomnia and sleep quality as well as improvements in objective measures of sleep. The analyses of the group that received CBT-I followed by 6 weeks of follow-up revealed that the sleep benefits gained during treatment were maintained at follow-up. In addition, QOL significantly improved at follow-up. No significant effects were found for psychological or fatigue variables.

The results are comparable to the sleep findings in previous studies that looked at group CBT-I therapies in breast cancer survivors, but differ in the effects found in psychological, fatigue and QOL measures. These results show that individual CBT-I is efficacious in improving sleep in breast cancer survivors. Further studies with greater sample size will help better understand the relationship between treating insomnia and psychological, fatigue and QOL variables in breast cancer survivors.


Symposium Abstract (2007)
Introduction
Survivors of breast cancer often suffer from insomnia. Sleep problems and correlated symptoms can last for years after the end of treatment. The present data are from an ongoing study testing the effects of a cognitive behavioral treatment for insomnia (CBT-I) on sleep, depression, anxiety, and quality of life in breast cancer survivors

Methods
The study is a 12-week randomized controlled crossover design, with participants being randomized to either 6 weeks of CBT-I followed by 6 weeks of follow up (i.e., group 1), or six weeks of treatment as usual (TAU) followed by six weeks of CBT-I (i.e., group 2). Self-reports of insomnia (Insomnia Severity Index: ISI) and quality of sleep (Pittsburgh Sleep Quality Index: PSQI) are assessed at baseline, 6 weeks, and 12 weeks. The CBT-I treatment is administered in 6 individual one-hour weekly sessions. The following data describe the results of the first four participants who have completed all assessments of the study protocol. Of these, 1 participant was randomized initially to CBT-I, and 3 were randomized to TAU followed by CBT-I.

Results All 4 participants (mean age=57 years, SD=9, range=46-67) had reduced levels of insomnia and sleep disruption comparing baseline (ISI: mean=18.2, SD=3.9, range=13-22; PSQI: mean=13.5, SD=2.4, range=11-16) to after the CBT-I (ISI: mean=5.7, SD=3.9, range=2-11; PSQI: mean=5.2, SD=2.9, range=3-9). In addition, the 3 participants in group 2 did not improve during the 6 weeks of TAU (ISI: mean=18.3, SD=1.5, range=17-20; PSQI: mean=13.3, SD=2.5, range=11-16). The participant randomized to initial CBT-I continued improving during the follow up (ISI: score=0, PSQI=1).

Discussion
Although these data are very preliminary, breast cancer survivors appear to benefit from CBT-I. After 6 sessions of CBT-I all 4 participants reported having no insomnia and better sleep quality. A larger sample size, currently being recruited, will permit statistical analysis of these differences.