CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
Completed · Not applicable
Conditions studied: Insomnia
In brief
This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.
Key facts
- Study ID
- NCT02756390
- Run by
- Dana-Farber Cancer Institute
- People needed
- 56
- Starts
- 2015-12-01
- Expected to finish
- 2018-05-14
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 years of age
- History of a cancer diagnosis
- No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
- No surgery planned in the next 6 months
- Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
- Able to read and write in English
- Willing to attend study group sessions
- Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep.
You may not qualify if…
- Survivors who report ever being diagnosed with Bipolar Disorder will be excluded.
- Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded.
- Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period.
- Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder
- Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
- Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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