Conditions: Insomnia Fatigue
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

Participants will be randomized into 4 groups:

* Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
* Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
* Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
* Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Detailed description:
The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Arms:
arm 1: Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

Armodafinil 150 mg/day by mouth. arm 2: Control behavioral intervention is a sleep hygiene handout completed by participant.

Armodafinil 150 mg/day by mouth. arm 3: Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

No pharmaceutical intervention. arm 4: Control behavioral intervention is a sleep hygiene handout completed by participant.

No pharmaceutical intervention.

Interventions: intervention 1: BBT-I intervention 2: Control intervention 3: Armodafinil
Intervention descriptions: intervention 1: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone intervention 2: Control behavioral intervention is a sleep hygiene handout completed by participant. intervention 3: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.

Protocol document: