Heckler, C.E., Garland, S.N., Peoples, A.R., Perlis, M.L., Shayne, M., Morrow, G.R., . . . Roscoe, J.A. (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: A randomized placebo-controlled trial. Supportive Care in Cancer, 24, 2059–2066.

DOI Link

Study Purpose

To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.

Intervention Characteristics/Basic Study Process

Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.

Sample Characteristics

  • N = 88  
  • MEAN AGE = 56 years 
  • MALES: 12%, FEMALES: 88%
  • KEY DISEASE CHARACTERISTICS: Patients with any cancer who completed chemotherapy and/or radiation not less than one month prior and had no measurable disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients discontinued any prescribed or OTC sleep medications one week prior to the study and for the duration of the study

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified  
  • LOCATION: United States and Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Four am factorial
  • Randomized and blinded trials for medications but not for CBT-I

Measurement Instruments/Methods

  • Quantitative data of fatigue assessment using brief fatigue inventory (BFT)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

Results

Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI;  p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.

Conclusions

CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.

Limitations

  • Small sample (less than 100)
  • Study was a secondary aim of a previous trial.

Nursing Implications

This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.