Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer

Not Applicable

Completed

• Conditions: Chronic Insomnia
• Interventions: Behavioral: Cognitive behavioral therapy for insomnia; Behavioral: Healthy eating control

• Registration Number: NCT02121652
• Lead Sponsor: State University of New York at Buffalo

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.

Study Timeline

• Study First Submitted: 2013-10-25
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2022-06-20
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Results First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy	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.
Healthy eating control	Healthy eating control	Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Roswell Park Cancer Institute Thoracic Clinic; 🇺🇸 Buffalo, New York, United States

SUNY University at Buffalo; 🇺🇸 Buffalo, New York, United States