Depression Clinical Trial
Official title:
Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors
This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.
PRIMARY OBJECTIVES:
I. To complete a randomized pilot trial of a cognitive-behavioral anxiety-insomnia
intervention to determine the impact of this intervention on patient worry, intolerance of
uncertainty, and sleep efficiency.
II. Explore the underlying endocrine and immune mechanisms responsible for a specific
symptom cluster (anxiety-insomnia-depression-pain-fatigue) observed among advanced cancer
patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary
and worry record daily in weeks 1 and 5. Patients also receive education on the components
of anxiety (physical cognitive, and behavioral) and practice relaxation techniques and
behavioral sleep strategies in weeks 2-5. Blood draw is optional.
ARM II: Patients wear a wrist actigraph, collect saliva samples, and complete a sleep diary
and worry record daily in weeks 1 and 5. Blood draw is also optional. This is a wait-list
control arm, so patients in this arm, after a six-week period of treatment as usual with
their oncologist, then receive the intervention.
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