Trial Outcomes & Findings for Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer (NCT NCT02121652)
NCT ID: NCT02121652
Last Updated: 2023-03-07
Results Overview
Sleep Efficiency \> 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.
COMPLETED
NA
44 participants
5 weeks
2023-03-07
Participant Flow
Four participants were excluded from the study after screening positive (e.g. \> or = to 15) on the overnight ApneaLink test and referred to sleep medicine for further assessment.
Participant milestones
| Measure |
Healthy Eating Control
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
|
Cognitive Behavioral Therapy
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Healthy Eating Control
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
|
Cognitive Behavioral Therapy
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer
Baseline characteristics by cohort
| Measure |
Healthy Eating Control
n=20 Participants
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Healthy eating control: Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
|
Cognitve Behaviroal Therapy
n=20 Participants
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
Cognitive behavioral therapy for insomnia: Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
64.45 years
STANDARD_DEVIATION 8.00 • n=99 Participants
|
66.45 years
STANDARD_DEVIATION 7.51 • n=107 Participants
|
65.45 years
STANDARD_DEVIATION 7.73 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 weeksSleep Efficiency \> 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.
Outcome measures
| Measure |
Healthy Eating Control
n=11 Participants
Healthy Eating Control
|
Cognitive Behavioral Therapy
n=14 Participants
Cognitive Behavioral Therapy
|
|---|---|---|
|
Sleep Efficiency
|
79.70 percentage of sleep efficiency
Standard Deviation 10.21
|
85.21 percentage of sleep efficiency
Standard Deviation 20.54
|
Adverse Events
Healthy Eating Control
Cognitve Behaviroal Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Suzanne S. Dickerson
University at Buffalo School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place