Savard, J., Simard, S., Giguère, I., Ivers, H., Morin, C. M., Maunsell, E., . . . Marceau, D. (2006). Randomized clinical trial on cognitive therapy for depression in women with metastatic breast cancer: psychological and immunological effects. Palliative and Supportive Care, 4, 219–237.

The cognitive-behavioral therapy (CBT) intervention for insomnia consisted of eight weekly sessions of approximately 90 minutes, offered in groups of four to six patients, and delivered by a clinical psychologist. The treatment protocol was multimodal and combined behavioral (e.g., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene, fatigue and stress management) strategies that were described in a treatment manual given to all participants. A booster session was offered to participants one month after the end of treatment. Missed treatment sessions were rescheduled; therefore, all patients received the entire treatment program. Outcomes were evaluated at the conclusion of the intervention, as well as at three, six, and 12 months after the end of treatment.

Fifty-seven women with stage I to III breast cancer who met the diagnostic criteria for a chronic insomnia syndrome (CBT group, n=27; comparison group, n=30) were included.

Diagnostic criteria included

• Difficulty initiating and/or maintaining sleep, whereby sleep-onset latency and/or wake after sleep onset is greater than 30 minutes
• Sleep efficiency (ratio of total sleep time to total time spent in bed) was lower than 85%
• Difficulties occurring for at least six months
• Difficulties causing marked distress or significant impairment in daytime functioning (e.g., fatigue, disturbed mood, performance deficits).

Only patients whose insomnia was judged to be secondary to cancer were included in the study (i.e., those whose sleep difficulties were caused or aggravated by the cancer diagnosis or treatment).  Most of the sample had received prior adjuvant treatment with radiation therapy (85.2%), chemotherapy (37%), or hormone therapy (59.3%).  Slightly more than one-third of the sample was currently receiving hormone therapy (37%).

Exclusion criteria included severe major depression or other serious psychiatric disorder; presence of a sleep disorder other than insomnia (e.g., sleep apnea), presence of another illness affecting the immune system (e.g., human immunodeficiency virus [HIV] infection), and regular use of a psychotropic medication other than hypnotics (e.g., antidepressants) unless the dosage used was stable in the last month and did not increase during the study; and current involvement in psychotherapy.

• Outpatient
• Large academic medical center
• Participants were recruited through flyers and pamphlets, ads placed in local newspapers, and physician referrals.

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial, with patients randomly assigned to CBT for insomnia or a wait-list control group.

Multidimensional Fatigue Inventory (MFI)

Analysis of pooled data revealed a statistically significant improvement in fatigue from pre- to posttreatment, with maintenance of this improvement during the 12-month follow-up period.

• The fact that the study sample was primarily Caucasian and well educated and all patients were survivors of breast cancer may limit the generalization of the findings.
• The use of a wait-list control condition did not allow for the control of nonspecific therapeutic elements in the intervention, such as therapist empathy, group support, etc.
• A modest amount of continuing education, as well as access to some instructional materials for patients, are needed to prepare health care professionals to deliver CBT interventions for insomnia.