Cancer, Insomnia
Conditions
Keywords
cancer, insomnia, CBT, CBT-I, cognitive behavioral therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCBT-I
Eligible participants will receive CBT-I by a licensed clinical psychologist.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the score on the Insomnia Severity Index (ISI) | baseline and at 19th week | The ISI assesses the severity of insomnia symptoms and subjective daytime impairments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of diary-assessed sleep onset latency | baseline and at 19th week | Sleep onset latency is the time it takes to fall asleep |
| Change of diary-assessed wake after sleep onset | baseline and at 19th week | wake after sleep onset is the total duration of nighttime awakenings |
| Change of actigraphy-sleep onset latency | baseline and at 19th week | Sleep onset latency is the time it takes to fall asleep |
| Change of actigraphy-assessed wake after sleep onset | baseline and at 19th week | wake after sleep onset is the total duration of nighttime awakenings |
Countries
United States
Outcome results
None listed