Espie, C. A., Fleming, L., Cassidy, J., Samuel, L., Taylor, L. M., White, C. A., . . . & Paul, J. (2008). Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. Journal of Clinical Oncology, 26, 4651–4658.

Nurses administered a cognitive-behavioral therapy (CBT) intervention consisting of five weekly 50-minute sessions provided during early afternoon or early evening. The intervention included standard CBT components, such as stimulus control, sleep restriction, and cognitive therapy strategies. The nurses had participated in CBT courses and psychologist-supervised practice and had audiotapes from randomly selected sessions evaluated for congruence with intervention components and principles.

Participants were randomized to either receive CBT or treatment as usual, with stratification for center, prerandomization Pittsburgh Sleep Quality Index (PSQI) scores, existing treatment for insomnia, and tumor type. A 2:1 treatment allocation, in favor of the intervention, was selected to make efficient use of the available CBT sessions and minimize the time patients would have to wait for CBT, thus reducing the potential for patient dropout. Researchers used several strategies to promote intervention fidelity and the integrity of the treatment allocations:  the study staff did not interact with other patients in the treatment as usual group, clinicians working with participants in the treatment as usual group did not receive any information about CBT; and printed intervention materials were developed.

• Participants were recruited by mail, posters, and directly by clinic staff.
• Participants were drawn from the outpatient clinics at one of two large oncology centers in Great Britain.
• Of the 150 participants, 103 were female and 47 were male.
• Mean age was 61 years (range 38–86).
• Less than 40% of participants were employed.
• Median interval between cancer diagnosis and the presentation of insomnia complaint to the research team was longer than two years.
• All participants had insomnia longer than six months, with a group median of 30 months.
• Twenty-five percent of participants had insomnia longer than five years.
• Twenty-three percent of the sample took a hypnotic medication for one or more night of the 10-night baseline.
• Participants had breast, prostate, bowel, or gynecological cancer and satisfied the diagnostic criteria for chronic insomnia (defined as a mean value longer than 30 minutes for complaint of delayed sleep-onset latency and/or wake time after sleep onset, occurring three or more nights per week for three or more months and affecting daytime function).
• Participants also had to screen greater than five on the PSQI, a psychometrically robust instrument that identifies clinically significant sleep disturbance.
• Treatment (radiation therapy or chemotherapy) had to be completed by one month or more with no further anticancer therapy planned (excepting adjuvant hormone therapy).
• Participants with acute illness, an estimated prognosis less than six months, confusional problems, drug misuse, evidence of other sleep disorders (e.g., sleep apnea), or with untreated psychiatric disorders were excluded.

This was a randomized, controlled, pragmatic, two-center trial of CBT.

Fatigue Symptom Inventory Interference Subscale

Compared with usual care, CBT resulted in a statistically significant improvement in fatigue interference/daytime fatigue following CBT treatment, and these improvements were sustained at six-month follow-up. Two-thirds of CBT participants attended all therapy sessions, and 94% attended at least three of five CBT sessions. There were similar levels of attrition in the intervention (18%) and usual-care comparison (16%) groups.

Neither interventionists nor patients were blinded to study group allocation, and participants' knowledge that they were assigned to particular treatment arms may have influenced their responses on patient-reported outcome measures.