Trial ID or NCT#

NCT01011218

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Oxana Palesh
Oxana Palesh
Psychologist
Associate Professor of Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences)
David Spiegel
David Spiegel
Psychiatrist
Jack, Lulu and Sam Willson Professor of Medicine
Frank E. Stockdale
Frank E. Stockdale
Medical oncologist, Breast specialist
Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus

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CONTACT

Oxana Palesh, PhD, MPH
(650) 725-7011