Chronic Insomnia
Conditions
Keywords
lung cancer survivors, insomnia treatment, cognitive behavioral therapy
Brief summary
The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.
Detailed description
A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALHealthy eating control
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
Sponsors
National Institute of Nursing Research (NINR)
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer * chronic insomnia
Exclusion criteria
* Other preexisting sleep disorders * Unstable medical illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | 5 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Cognitve Behaviroal 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Healthy Eating Control | Cognitve Behaviroal Therapy | Total |
|---|---|---|---|
| Age, Customized | 64.45 years STANDARD_DEVIATION 8 | 66.45 years STANDARD_DEVIATION 7.51 | 65.45 years STANDARD_DEVIATION 7.73 |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 14 |
| other Total, other adverse events | 0 / 11 | 0 / 14 |
| serious Total, serious adverse events | 0 / 11 | 0 / 14 |
Outcome results
Primary
Sleep Efficiency
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.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Eating Control | Sleep Efficiency | 79.70 percentage of sleep efficiency | Standard Deviation 10.21 |
| Cognitive Behavioral Therapy | Sleep Efficiency | 85.21 percentage of sleep efficiency | Standard Deviation 20.54 |