Savard, J., Simard, S., Ivers, H., & Morin, C. M. (2005). Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: sleep and psychological effects. Journal of Clinical Oncology, 23, 6083–6096.

Patients received multimodal cognitive-behavioral therapy (CBT) that combined cognitive, behavioral, and educational strategies. Treatment consisted of eight weekly sessions administered in a group of four to six participants and was combined with use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue and stress management. The treatment protocol was based on clinical procedures developed by Morin (1993) and was adapted by the investigators for the cancer population.

Fifty-seven breast cancer survivors were randomly assigned to a CBT (n=27) or waiting list condition (n=30).

Patients were included in the study if they

• Had completed radiotherapy of chemotherapy for a stage I to III breast cancer at least one month prior to enrollment
• Met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Editoin (DSM-IV) diagnostic criteria for a chronic insomnia syndrome.

Patients who regularly used psychotropic medications other than hypnotics (e.g., antidepressants) were excluded unless the dosage use was stable in the last month and did not increase during the study. Individuals currently receiving psychotherapy were also excluded.

• Cancer research facility
• Participants were recruited via fliers and pamphlets, advertisements placed in local newspapers, and physician referrals.

Patients were undergoing the long-term follow-up phase of care.

This was a randomized, controlled trial with a waiting list control group and a 12-month follow-up period to assess the short- and long-term effects of the intervention.

Multidimensional Fatigue Inventory (MFI)-French Canadian version to measure fatigue

Pooled analyses within an intent-to-treat framework revealed significant differences between pre- and posttreatment on fatigue (p < 0.001). No significant difference was detected between posttreatment and the three-, six-, and 12-month evaluations of fatigue, suggesting that the clinical improvement relative to the outcome of fatigue was durable.

• Participants were primarily Caucasian and well educated.
• Of the patients, 36% who were interested in the study and had responded to the advertisement screened out or declined to participate once they heard more about the study. This may limit the generalization of the findings.
• Reasons for exclusion included severe psychiatric disorder, not meeting the DSM-IV diagnostic criteria for chronic insomnia, or having insomnia that was not judged to be secondary to cancer (some participants were also screened out due to ongoing cancer treatment).
• Approximately 20% of the individuals judged the study to be too burdensome when they learned the treatment details and declined to be enrolled.
• Use of the waiting list control condition did not allow for the control of nonspecific therapeutic ingredients.
• Trained personnel were needed to administer the CBT intervention.
• Group treatment had costs.

It is not possible to determine whether the improvements in fatigue observed in this study are attributable to the CBT strategies or to other ingredients common to all psychotherapeutic approaches (e.g., therapist empathy, group support). Sustained improvements in fatigue may also be a result of a maturation effect wherein fatigue declined as might be expected, with greater distance from treatment.