Lebanon, New Hampshire 03766

  • Insomnia

Purpose:

The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.


Study summary:

This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.


Criteria:

Inclusion Criteria: 1. 18+ years of age 2. have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments) 3. are diagnosed with gastro-intestinal cancer; 4. have life expectancy > 6 months; 5. are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure; 6. will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I; 7. are English-speaking and able to provide voluntary, written consent. Exclusion Criteria: 1. unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment; 2. other sleep disorders; 3. bipolar disorder; 4. unmanaged serious mental illnesses; 5. suicidal ideation/intent/plan; 6. unstabilized pharmacological treatment for insomnia; 7. night-shift employment.


NCT ID:

NCT03561064


Primary Contact:

Principal Investigator
Wai S Chan, PhD
Dartmouth-Hitchcock Medical Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03766
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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