Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.

Detailed Description
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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.

Official Title
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Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia
* Behavioral: Healthy eating control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy eating control<br>Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. | Behavioral: Healthy eating control<br>* Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.<br>|
| Experimental: Cognitive behavioral therapy<br>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. | Behavioral: Cognitive behavioral therapy for insomnia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer survivors, insomnia treatment, cognitive behavioral therapy